A METHOD AMD APPARATUS FOE MEDIATING PROPRIOCEPTIVE SKIN AMD BODY SENSORS, VISION, VESTIBULAR AND SOMAT -SENSAT1GN ACTING IN COMBINATION WITH BRAIN FUNCTION OR NEUROSENSORY-MOTOR SYSTEM

FUNCTION

jOl] PRIORITY

\92\ This application is related to LI .S, Provisional Patent Application Ser. No.

61807260, Sled on April 1, 2013, which is incorporated herein by reference and to which priority is claimed pursuant to 35 USC \ 19. f03j Background

104} Field of the Technology

[85} The disclosure relates to the field of sensory motor orthonVprosthetic systems and methods for detecting and/or mediating proprioceptive loss, inability to engage the appropriate muscles (hypo or hypertonic), or decreased ability to interpret sensor information in a person, mammal or other animal having a postural control, balance, or other disorder with a stimulating device tending to improve one or more of the person's or animal's function; inclnding visual, somatosensory, vestibular, perception of an upright pasture, sway, static and dynamic balance, raotor control coordination, gait, speech, swallowing, handwriting and/or raotor control.

[66] Description of the Prior Art

[07] Postural control and symmetry of the body of a human and animal is described as the ability to maintain a neutral position in static upright static positions, such as sitting or standing, during dynamic activities, such as moving from one position to another, and to react to destabilizing stimuli, such as a. series of internal or external sensory Inputs to the body via the somatosensory, vestibular and or visual systems. These sensory systems can be challenged to trigger automatic postural control via primitive or refined reflexes and pathways. However, only about 5% of people whom we ha e tested using balance-based, torso- weighting, (BBTW), have high postural control, in a series of BBTW tests described in: US Patents 8,215,773; 7,156,792; 7,708,673; US Patent Publications 20110043755: 20100248915; 20070099775: and

20040147377, incorporated herein by reference, we often found that even relatively healthy individuals still had areas of postural insufficiencies that can be improved with the use of strategically placed weights on the body . In addition we found that animals and individuals respond and can move in more coordinated patterns with improved stability from the use of a selective strategically placed weight or weights on the body according to directional md symmetry related tests.

{68] in addition, in some cases we have found that people with directional balance impairment and rotational asymmetry, once corrected, clinically respond positively with improved visual testing, ocuhnotilities, fixation disparity, sieriognosis, depth perception, eye movement, eye alignment, and vestibular ocular coordination. Clinically this has been shown in. patients with MS, ataxia, stroke, traumatic brain injury and cerebral palsy. Some people also demonstrate improved coordination testing in the upper ( including hand writing, hand to mouth, finger to nose, etc ) and lower extremities as well as the trunk over the lower extremities. Some show less torso and extremity tremor as seen in the Lift. Iab9

(!vit ^^^

Individuals also may show improved, somato-sensory, visual, and vestibular organization testing on the Smart BALANCE MASTER'S ¹ , a trademark of euroCora, Clackamas, Oregon, for an apparatus, which provides objective assessment and retraining of the sensory and voluntary motor control of balance with visual biofeedback on cither a stable or unstable support surface and in a stable or dynamic visual environment. The BALANCE MASTERS system utilizes a dynamic 18" x ί 8" dual force plate wii.li rotation capabilities to measure the vertical forces exerted by the patient's feet and a moveable visual surround. Body Sway in eyes open and closed and on fiat surface and foam and walking have also been shown to improve using inertia! measurement units (lMUs) such as APDMTM wearable sensors made by APD Inc.. of Portland, Oregon, which are wireless inertia! measurement units about the size of a watch using solid state MEMS technology to precisely record movement with a complete kinematic sensors suite that include triaxial accelerometers, gyroscopes, and magnetometers, in. the medical field, these IMOs are ideal for monitoring human movement for clinical research, biomechanical research, physical therapy research, movement disorders research, and athletic tuning.

Patients have also demonstrated improved sensory motor strategies, center of gravity alignment, and motor control. Previously as set form in U.S. Patents 7,150,?&2;

7,708,763; 8,215,773, and U.S. Patent Application. 12/728,873, incorporated herein by reference, we used a weighting garment and orthotics to improve balance. In particular, the person was put through a series of both static and dynamic testa to determine directional impairment. Adjustable balance evaluation systems were used to determine the strategic placement of a weights) to reduce the patient's directional balance loss. For an example of static application, if a person was felting backward and unable to sit or stand, weights could be applied anteriorly until static ability was achieved. In the example of a dynamic application, if a person, had the following problems: decreased ability to resist right -rotation of the upper torso; loss of balance of the upper torso to the right; and a posterior loss of balance of the upper and lower body, the weigh ting process would be as follows. A fraction of a pound, e.g. ¼ , ½ pound or less, weigh t would be placed or attached to a garment at a position between the shoulder blade on the left between the spine and scapula.. This -placement immediately corrects rotation 99% of the time (occasionally the weight is moved ri or down a fraction of ae inch, e,g, 1/8 - ½ of an inch, to get the correct mo tor control point for the individual patient where i t controls this rotational asymmetry, firing latency, and strength). The person is then perturbed to the right by an exterior force applied to the patient at the upper and lower torso. The rotation weight may correct a lateral imbalance as well, if it did not, the clinician would compare the posterior loss of balance as well as the lateral. If the person lost their balance posteriorly and laterally to the right, then another weight is placed anteriorly and laterally to the left of the navel In some cases the weigh t is placed on the same side and the person is weighted into the direction of their loss and it corrects it Repeated external perturbations and weight adjustments are made until all loss of balance is stabilized. After these adjustments if there is directional loss that can be identified during dynamic or static activities such as walking, standing, standing on foam eyes closed, standing in sharpened Romberg ( tandem stance ) etc. minor adjustment in the weight placement or amounts ma or may not be required. Once the individual weighting strategy is determined with the evaluation system, the evaluation is used to create customized garments for the specific patient for enhancing or improviag balance.

[10] Described below are customized garments for enhancing balance. Methods of creating customized garments are disclosed, which methods enhance balance using the adjustable balance evaluations.

|I1J While the average person or animal doesn't notice that they are not completely in balance , they may note a loss or lack of balance if their balance i s challenged in a manner similar to how athletes challenge themselves. It is possible that the personal small, amounts of instability lead to subtle imbalances which, in turn leave a person at a less than desirable coordination level or mildly off balance using one side of their body more than the other,. For example, a person, who is inherently off balance by a small amount, e.g. lean or land on the Lower extremity even, a fraction of a pound or heavier. Any imbalance could cause a balance-based arthritis pain or increased muscular tension or pain on one side of their body. This imbalance may lead to sports injuries or inefficiencies in. their ability. For example when moving at greater speeds the instability may increase asvelocitics, magnitudes, and forces on the body increase. This imbalance may cause decreased efficiency of movement thereby decreasing stamina. In A recent study demonstrated a significant difference in gait velocity, in subjects with MS and healthy controls when strategically placed weights corrected imbalance with the BBTW Method,; each group increased averaged its average gait speed by 4%. in addition other spatial temporal aspects of gait i mproved. ( submitted for publication) Patients with MS , vestibular, ataxia and other diagnoses often report they feel more grounded.

\12] While the details of the underlying mechanism, neurology or physiology relating to the efficacy of weight balance mediation, is not well understood, it is appreciated by the inventors of the present disclosure that interaction with the Ml spectrum of proprioceptive skin and body balance sensors in combination with brain function is intimately involved, in a sense it is re-weighting the sensory system with correct input. The sensory system has multiple sensors that pick up a variety of inputs and relay them in different pathways in the nervous system. There is a redundancy built into the nervous system so that increased input from one source may be picked up by another part of the nervous sy stem enabling better balance and movement control. In addition just as medicines have complementary effects when used in combination, the sensory motor system may also respond to a variety of signals alone or in combination providing enhancement to aspects of balance and motor control. This includes combinations of

pharmaceuticals that also increase sensory system and motor output in combination, with sensory enhancement in the form of non-weight or weight: stimulus or an combinations thereof that can be sensed by or input into the nervous system .

[13} Therefore, what is needed is a method and apparatus in which the mediation of limitations or defects in the proprioceptive skin and body sensors in combination with brain function can be realized or efficaciously practiced using any one of or multiple modal stimuli gateways and any one of or multiple body feed forward or feedback or response pathways.

114] Brief Summary of the Invention fl5| The illustrated embodiments of the invention include an type of stimuli needed to maintain the body upright in a static position or along a continuum of more difficult postural control activities depending on the functional level of the subject being tested, making the test harder by increasing the challenge to a -person maintaining stability to identify a directional, i nstabili ty by using perturbing stimulus in combination with any type of observation of any type of response to apply any type of non-weight corrective stimulus. We also include any type of perturbing stimulus with any type of observation of any type of response to apply any type of non-weight and weight corrective stimulus. The corrective stimulus in both situations may be any type of non-weight and/or weight stimulus. The combination of weight and TENS applied to the same nerve pathway controlling the body was better than weight-based stimulus alone or TEN stimul us alone with respect ^' to motor control of a patient with a brain stem bleed The combination improved the smoothness of the motor control of gait aad trunk stability. The definitions of non-weight and weight stimuli tor the purposes of this specification and claims are provided below in the disclosure of the detailed embodiments.

|Mj The illustrated embodiments in particular include corrective electrical stimulus

(called eStim) and/or corrective vibrational stimulus (tactile stimulus). Still further, the invention inci des within its scope a stimulating device containing sensors., such as tri-axia! accekrometers, gyroscopes aad magnetometers, wherein the stimulating device is a weight, a vihrotactile device, and/or an eStim applicator, TENS, using ac dc current. Any device capable of generating a body or skin stimulus may also have the above sensors and/or specific types of stimulating devices included, within, it. The stimulating de vice is capable of attaching to the person via a gel pad, a weighted gel pad, or a vibrotactile stimulator in a gel pad. The stimulating device includes any combination eStira, weight and/or vibration stimu!or attached by possibly thermalked gel pad of any weight or any other combination of stimuli with a possibly therrnalized gel pad or any form of attachment in or on a garment or device or affixed to the skin in any form.

[J.7J The i llustrated embodiments of the invention include a method of impro ving a subject's sensory motor system, visual, somato-sensory, and/or vestibular system, comprising the steps of: evaluating the subject's somatosensory, visual, vestibular, and/sensory motor nervous system including rotational symmetry, balance reactions in static, dynamic and. perturbed stimulation from any position; stimulati g the subject's somatosensory, visual, vestibular, muscular balance, and/or motor nerve system by providing one or more selectively placed repositionable non-weight stimuli from a device worn or placed on the subject by any means; reevaluating the subject's somatosensory, visual, vestibular, muscular balance, a 'or motor nerve system; comparing the subject's reevaluated somatosensory, visual, vestibular, muscular balance, and'er motor nerve system to the subject's evaluated somatosensory, visual, vestibular, muscular balance, and/or motor nerve system; and repeating the steps of evaluating, stimulating, reevaluating and comparing until the subject's reevaluated somatosensory, visual, vestibular, muscular balance, and/or motor nerve system shows improvement after the comparison of the subject's reevaluated somatosensory, visual, vestibular, muscular balance, and/or motor nerve system to the subject's evaluated somatosensory, visual, vestibular, muscular balance, and/or motor nerve system. The somatosensory, visual vestibular, muscular balance, and or motor nerve system can be the object of the steps in any combination or separately according to subject's need. [18} The repositionable stimuli can be any kind of stimuli which can be sensed, either at sitbthreshoid. insensate levels or at perceived above threshold levels. Devices which are capable of producing such stimuli incl ude the output from at least one or more electrical electrodes, pressure transducers, vibration transducers, acoustic transducers, stretch transducer, aromatic generators, light sources, flavor sources, thermal transducers, pais generators, or stimuli generator.

[19} The non-weight stimuli of die illustrated embodiment are electrical skin stimuli

(eStim) produced by transcutaneous electrical nerve stimulation (TENS) devices and/or skin tactile stimuli produced by vibrotactile stimuli . TENS is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS by definition covers the complete range oftranscutancous!y applied can-eats used for nerve excitation, although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain, no such restrictive intent is included in the current specification. The TENS device is usually connected to the skm using two or more electrodes. A typical battery-operated TENS device is able to modulate pulse width, frequency and intensity.

Generally, TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or at a low frequency (<10 Hz) with an intensity that produces motor contraction.

|2i)J in another embodiment the method of improving a subject's vestibular, n uscular balance, and/or neurosensory motor nerve system comprises the steps of evaluating the subject's vestibular, muscular balance, and/or motor nerve system to determine a probable cause of limitation or defect therein: and stimulating the subject's vestibular, muscular balance, and/or motor nerve system by attaching at least one or more repositionable non-weight stimuli to a device worn or attached to the subject by any means according to the probable cause of limitation or defect therein.

[21} The method farther includes the steps of; reevaluating the subject's vestibular, muscular balance, and or ^• aewosensory-motor nerve system; comparing the subject's reevaluated vestibular, muscular balance, and/or motor nerve system to the subject's evaluated vestibular, muscular balance, and/or motor nerve system; and repeating the steps of evaluating, stimulating, reevaluating and comparing until the subjec t's reevaluated vestibular, muscular balance, and/or neurosensory motor nerve system shows improvement after the comparison of the subject's reevaluated vestibular, musc ular balance, and/or motor nerve system to the subject's ev aluated vestibular, muscular balance, and/or motor nerve system. |22} The illustrated embedments also include any apparatus used in the perfor aace of any of the above methods. For example, the apparatus comprises: a pair of eyeglasses or an eyeglass frame through which visual stimuli would be provided; a garment or wearable device through which nonvisual, non-weight stimuli would be provided, or a leg, arm, hand or foot prosthesis, The garment is configured to be worn on the subject's torso or body or the garment is a cap, headband, or hat or neck brace. In another embodiment the apparatus includes: an orthotic configured to fit the subject's torso, including a bra, bell, a stop of magnetic material to a piece of a garment or apparatus; or a neuroprosmesis, worn or attached anywhere ra the body. The orthotic would provide a sense of confinement, support or rigidity for a body part. The prosthesis is a prosthetic limb or more specifically a prosthetic leg, which would provide a sense of bodily extension or replacement for a lost limb. Such orthotics or prostheses provide at least corrective stimuli or provide an attachment platform or carrier through which eSti or vibrational corrective stimuli can be provided. A prosthetic is anything that replaces a bod organ or a portion of one and replaces its functions. A hearing aid is a prosthetic in this sense of the term, A sensory system is one of the body organ systems, like the auditory system as a whole, which would include the hearing aid.

[23} More particularly, the illustrated embodiments of the invention include A method of improving functioning of at least a portion of a. subject's nervous pathway system including the steps of: observing the subject's ability to maintain their stability m an unstimulated state;

selectively applying a non-weight stimulus to the on the subject to enhance the subject's stability; observing the subject's ability to maintain their stability with the selectively applied non-weight stimulus; and repeating the steps of selectively applying a son-weight stimulus to the on the subject to enhance the subject's stability and observing the subject's ability to maintain their stability with the selectively applied non-weight stimulus until an improvement in stability control by the subject is observed,

[24} The illustrated embodimen ts further include a method combining the above steps with those that follow below, omitting or limiting the number of repetitions of the above ste s before performing the steps that follow below, or omi tting ail of the above steps and performing the steps of: stimulating at least the portion of the subject's nervous pathway sy stem by providing at least one perturbing stimulus; evaluating the Subject's response to the perturbing stimulus; providing at least one corrective non-weight stimulus to the subject's nervous pathway system; restanlating at least the portion of the subject's nervous pa thway system by providing the at least one perturbing stimulus; comparing the subject's response to the resrimulation of at least the portion of the subject's nervous pathway system; and repeating the steps of stimulating.

? ^• evaluating, providing at least one corrective non-weight stimulus, providing at least one corrective non-weight stimulus, and comparing the subject's response to the restimulation imtii the subject's response improves to an optimal one for the treated subject.

\25] The step of providing at Ieast one corrective non-weight stimulus to the subject's nervous pathway system comprises providing at least one corrective nonweight arid weight stimulus in combination to the subject's nervous pathway system,

|26| The step of repeating the steps of stimulating, evaluating, providing at least one corrective non-weight stimulus, providing at Ieast one corrective non-weight stimulus, and comparing the subject's response to the restimulation until the subject's response improves io an optimal one for the treated subject comprises providing at least one corrective non-weight stimulus to a different location on the subject, providing a different degree, amount or intensity of the at ieast one corrective non-weight stimulus to the subject at the same or different location on the subject, or providing a different kind of corrective non-weight stimulus to the subject at the same or different location on the subject or any combination thereof

[27J The step of providing at least one corrective non- weight stimulus to a different location on the subject, providing a different degree, amount or intensity of the at least one corrective non-weight stimulus to the subject at the same or different location on the subject, or providing a different kind of corrective non-weight stimulus to the subject at the same or different location on the subject further comprises providing at least one corrective weight stimulus in combination with the non-weight stimulus.

|28] The step of providing at least one corrective non-weight stimulus to the subject's nervous pathway system comprises providing a stimulus from an from one or more electrical stimulators, pressure transducers, vibration transducers, acoustic transducers, aromatic generators, light sources, flavor sources, thermal transducers, pain generators, or bodily stimuli generator. [%9\ The seeps of stimulating, ev aluating, providing at least one corrective non-wei ght stimulus, providing at least one corrective non-weight stimulus, and comparing the subject's response to the restimulation of the subject's nervous pathway system comprises stimulating, evaluating, providing at least one corrective non-weight stimulus, providing at least one corrective non-weight stimulus, and comparing the subject's response to the restimulation of the subject's vestibular, vision, muscular balance, sensory motor nervous, proprioceptive or somatosensory systems.

\M] The illustrated embodiments also include an apparatus for improving iunetioiring of at least a portion of a subject's nervous pathway system including a garment or device worn or disposed on the subject; and at least one stimulator di posed on, in or within the garment or device capable of providing at least one correcti ve non-weight stiiiiuks to the subject's nervous ^• pathway system. The kind of non-weight stimulus provided by the stimulator to the subject's nervous pathway system, the amount, degree or intensity of the stimulus provided by the stimulator to the subject's nervous pathway system, and/or where the body location of non-weight stimulus provided by the stimulator to the sub ject's nervous pathway system is determined by an ^¬ one of the reiterative diagnostic methods described above or any other reiterative diagnostic method now known or later devised for determining the application of a type, degree and location of a non-weight stimulus to the subject with or without a weight stimulus.

[31 j in one embodiment the device comprises a pair of eyeglasses or an eyeglass frame.

[32} in another embodiment the garment is configured to be. worn on the subject's body , head or torso. The garment includes a cap, headband, hat or neck brace.

[33} in still another embodiment the device comprises an orthotic configured to fit the subject's torso, including a bra, belt, vest, undergarment or a strip of magnetic materia! to a piece of a garment.

[34| In yet another embodiment the device comprises a prosthesis worn or attached to or on the subject's body . The prosthesis comprises a prosthetic limb or a prosthetic leg.

[35} The illustrated embodiment include not only the end stage product with or without indicia to be worn or disposed on the subject but also a test garment or test device having indici thereon used by the therapist in the assessment method and to which the at least one stimulator is attachable at any location thereon to allow for reiterative repositioning of the stimulator thereon and recordai of an optimal location of attachment for the treated subject. |36j The apparatus further includes at least one other stimulator disposed on, in or within the garment or device capable of providing at least one corrective weight stimulas to the subject's nervous pathway system in combination with the at least one stimulator capable of providing at least one corrective non-weight stimulus.

{37} The apparatus further includes a plurality of stimulators capable of providing corresponding corrective weight stimuli to the subject's nervous pathway system in combination with a plurality of stimulators capable of providing at corresponding corrective non-weight stimuli.

[38} The stimulator comprises an eStira stimulator, or a vibrotaeti!e stimulator.

[39} In another embodiment the stimulator comprises a combined non-weight eStim and vibrotactik stimulator for providing corresponding stimuli at the same location on the body of the subject. {40} in yet another embodiment the stimulator comprises a combined non-weigltf eStaa and vibrotactile stimulator and a weight for providing corresponding stimuli at the same location on the body of the subject.

|41] An apparatus for improving ronctioning of at Least a portion of a subject's nervous pathway system including a garment or device worn or disposed on the subject; an electrical stimulator disposed on, in or within the garment or device capable of providing a corrective electrical stimulus to the subject's nervous pathwa system through, a skin-contact electrode; and a corrective weight combined with the electrical stimulator to provide a weight- based stimulus. The combined electrical stimulator or skin-contact electrode and weight could be supplied without disposition in, on or within the garment or device, but be directly applied to the body location and with a degree of stimuli as determined by the. reiterative diagnostic method.

[42| The apparatus includes a stimulator which provides:

a. A non-weight stimulus that is magnetic and is combined with a weight stimulus. b. A non-weight stimulus thai is vibration and is combined with a weight stimulus. c. A non-weight stimulus that is vibration and is combined with an electrical stimulus.

d. Non-weight stimuli that are magnetic and electrical and arc combined with a weight stimulus.

e. A non-weight stimulus that is a tensile force and is combined with a weight stimulus.

f. A non-weight stimulus that is a tensile force and is combined with vibration. g. A non-weight stimulus thai is a tensile force and is combined with an electrical stimulus.

h. A non-weight, stimulus that is pressure and is combined with a weight or nonweight weight stimulus.

L A non-weight stimulus that .is thermal and is combined, with a weight or nonweight stimulus,

j. Any non- weight stimulus that the sensory system can. pick up either alone or in. any combination.

[43] Brief Description of the Drawings

|44J Fig. I is diagram of a combined or integrated package for an eStioi, vibrotacttle stimulator and weight for use in one embodiment of the invention. [45| Detailed Description of the Preferred Embodiments

{46] As described above strategic weight placement provides a sensory input recognized by the animal or person that increases physical stability. While weight placement originally began as an observation and reiterative iest-retest process with each, weight placement on the person until balance control or stability in orientation, verticaliry, rotation resistance to perturbation as measured by direction, magnitude and latency was improved, in time, a correlation was made between an observation of a. specific weight placement and improved control of the patients ^* particular balance problems, and mascle, nerve or biofunetion related to balance and the correct wc.ight(s)and placewentis). Some patients also report decreased pain and effects on urinary flow, cognitive dual, tasking such as walking and performi ng math or .spelling. In addition the sensory re-weighn ^' ng also improves bow the visual and vestibular system is responding in to eurocom Sensory organizational testing and is related to decreased fails in during subject testing,

[ 7J in addition to the weight placement mediation discussed above, other tests and stimuli are applied to the body as disclosed below even where stimuli through weighting may or may not be beneficial. Strategic placement of sub-threshold stimulation, threshold stimulation, o contractile or tensile forces applied to the skin, muscles or tissue, taping, strapping, vibrating, touching, scratching, thermal stimuhis (temperature), electrical stimulation, optical stimulation, diathermic stimulation _* pressure, suction, acupressure or acupuncture or any other kind of stimulation of the proprioceptive, visual, and/or vestibular system body sensors in combination with brain or central nervous system functions can be employed in an analogous maimer by a generalization of the iterative test-'retest weight placement protocols an added, to by other perturbation methods where, one identifies the directional loss of balance. When the visual, ^• vestibular system is perturbed, a .harder paradigm is created for the bodily control system to handle, so thai the dysfunction, which, could he uncovered includes not only directions! control but symptomatic reactions such as dizziness or nausea. However, it is to be -understood that the illustrated embodiments of the invention are not limited to a method, which only emulates the prior procedures for strategic weight placemen: for balance remediation, but contemplates entirely new methodologies and apparatus as may be based on different biophysical stimuli and mechanisms. For example, included is stimuli using an electrical electrode muscle stimulation (eStjm), including but not. limited to AC, DC, pulsed or otherwise modulated signals through contact electrodes or electromagnetic coupling into or on the body. Expressly contemplated is any modulation or pulsation of any electrical stimulus at any frequency or frequencies, pulse widths, amplitudes or phases ox. combinations of the same. The electrode placement could be identical or similar to weight placement patterns or could be determined on a patient-by-patient basis using any kind ofbioelectrical (e.g. electrom ograrn (EMG)) or physical observation or measurement of sensory motor neuromuscular or proprioceptive skin and body sensor responses in combination with brain function to cancel out impairment of muscle or nerve function.

Multiple stimuli could be included in a combined stimulator for application to a single body location, e.g. an eStim. electrode 12 with its lead 18 coupled to a TEN unit (not shown), vibrotactile stimulator 14 with its lead 20 coupled to a battery pack (not shown) and weight 1 could be combined in an integrated package 10 as shown in Fig. 1 for application, to the body at the same location. Fcsr instance we could find that in people with disability or prone to injury that their body eieettoroyograph (EMG) shows certain muscles are activatable at sub-thresholds and others are activatable at over-thresholds. Using APDM wearable sensors, i.e. inertia.! measurement units incorporating wireless accelerometers, gyroscopes, and magnetometers, even subtle bodii motion changes can be observed in response to the stimuli and the stimuli coritroiied until the desired bodily motion sequence and response is obtained. Rotational and triaxial maladies can respond to each directional loss by applying a stimulus described, above to the visual, vestibular or somatosensory at the head, neck, trunk, pelvis or on the extremity to de- rotate or stimulate the malady into a more neutral position thus improving motion via attaching a stimulator having various controllable outputs or a. combination, of stimulators at different positions, each providing a different, or identical type and format of stimulation. For instance stimulation by mechanical vibration and weigh can be controllab!y applied to the bod to obtain the desired response(s). The stimulation need not only be applied from external sources, but can also include internally applied stimuli or prescription or nonprescription, drugs. For example, nonprescriptive medicaments, such as eurostimTM, which is a nootropic or one of a family of brain-enhancing drugs initially used to relieve symptoms of mind-degenerative illnesses such -as Alzheimer's and dementia, made by Mind Nutrition. LLC of Santa Fe, New Mexico, can be employed ^' in combination with external stimuli

| 8| it is anticipated that strategic weight placement according to-tne prior patents cited above may not be identical to electrode or other stimuli placements on the body, although it is expected that some overlap will occur. One object of the invention is to provide the necessary input with, the smallest amount of coverage on flic body so the wearer and the public will not know the wearer has on a corrective, sensory stimulating orthotic or neuroprosthetie device.

[49] In theory when the body is unable to resist a rotational force, anteri r or posterior or lateral perturbation of any part of the body, the force or perturbation could come from the floor or anywhere on the. body, an. input to ^' the body like a nudge, or a stimulation of the vestibular, sensory or visual system. This creates a physical instability. Cognitive issues may also arise since the ^' brain is having to focus the energy on being upright and cannot perform more than one task, if all forces are not equal and any directional instability is found, we have an opportunity to create positive change by adding input or natural bodily feedback to increase a subthreshold response, decrease an over-stimulated response, or change a co-contraction to more a normal response of agonists and antagonist muscles responses. Our system compares nonnal responses to those which are abnormal and normalizes the responses.

[50} Recently, we saw that when a patient was not able to resist rotation of the upper

^• torso, there was a. lack of muscle firing or activation on one side of the body and fascicuk ion. on the other side of the body. When we tested the other side, most or many of the museles engaged. An EMG recorded the differences on both sides of the body. When the weight was strategically placed to correct the rotational response, most of the firing was normal, if we perform the BBTW test with EMG observations, we find subthreshold activation of muscle groups in static as well as in dynamic testing. If we perform other means of perturbing the body with machines and with electromyography (EMG), we find patterns of subthreshold or over-threshold responses . In an EMG test of three patients with low back and radicular pain, we found high firing patterns of ^■ paraspiaal muscles that were immediately reduced by 50% with BBTW. By comparing the wrong sensory-motor nerve responses with correct sensory motor responses, we are able to facilitate the correct response in certain muscle groups to control the person's body. We can then treat those areas with selec ted appropriate sensory stimuli to bring them into a normalized response via the nenrosensory-motor system.

(51 j In this disclosure, we sense what the body response to perturbations or simply selected body movements by any one of various means now known or later devised to determine an impairment and then apply one or more snmu.i or inputs that feed the con ect information to the ^' body's .natural sensory neuromotor system to create a feed forward and better .feedback loop to the brain and/or centra! nervous system. We use tests to find impairments in the postural control system and add sensory information singularly or in combination to mediate the identified impairment. Our method identifies problems with static or dynamic control through observations and/or perturbations or methods challenging the input to various sensory systems, then add a sensory input to the same or different or in combination sensory motor system to correct the dysfunction followed by a reiterative tesfc'retest correctioa(s) to stabilize and improve or mediate body balance or other .functions. 152} Although it is not c ear ho the mediation functions within each patient, the disclosed method and use of the disclosed apparatus shows material changes or improvements in the somatosensory, visual and vestibular organization resulting in improved balance, vision, coordination, motor control, writing, speech, swallowing and other cognitive areas. In some cases, the mediation, improvement or restoration of normal muscle and nerve function is surprising, unexpected, uiipredicted and startling, even though it is repeatable in the patient. The same mediation does not, however, work equally well or in the same way in all. patients or to the same degree. The nature and degree of impairment in the functioning of proprioceptive skin and body sensors in combination with brain or central nervous system functioning is highly variable from one patient to the next, particularly given the wide v ariety and multiplicity of causative agents or mechanisms that could cause such impairments. The effects of the mediation, can be temporary or long term, which appears to be related to re-teaching the brain or central nervous system to subconsciously control muscular function using a different neurosensory motor protocol.

[53J Therefore, it must be understood that the illustrated embodiments of the invention include a device or devices that, detects the abnormal neurosensory functioning of proprioceptive skin and body sensors, vision, vestibular or somatosensory, and/or motor sensors in combination with brain or central nervous system functioning; and a method or device that ^• provides a mediating stimulus or stimuli to the proprioceptive skin and body sensors in combination with brain or central nervous system. The functioning of a proprioceptive skin and body sensor in combination with brain or centra! nervous system functioning is again tested to determine whether any norraalization of functioning has occurred. If aot, or if the observed functioning of a proprioceptive skin and body sensor in combination with brain or centra! nervous system functioning is not improved, a different stimulus or stimuli is provided or a different location or input location is provided for the stimulus or stimuli. The process and use of the devices continues reiie ative!y until satisfactory mediation is observed.

|54} Any device or methodology now known or later devised for stimulating a response from a proprioceptive skin and or body sensor in combination with brain or central nervous system may be employed. For example, a visual stimulation such as used in virtual reality training could be introduced to cause imbalance as a sensory perturbation. We would then alter the directional impairment with a corrective input for stabilization utilizing other areas of the sensory system to stabilize the visual induced impairment.

[55J Any device or methodology now known or later devised for detecting the response of a proprioceptive skin and/or body sensor in combination with brain or centra! nervous system may be employed. The method disclosed above may employ any device for creating a response from a proprioceptive skin and/or body sensor in combination with brain or central nervous system in combination with any device for detecting a response from a proprioceptive skin and/or body sensor in combination with brain or central nervous system. The sources of stimuli as well as the sensors of the responses may be applied directly to the body or held in contact with or proximity to the body or any portion thereof by any device, garment, appliance or other means tor positioning, holding, and/or allowing for repositioning of such sources and sensors.

[56} In practice certain categories of impairment are found to be responsive to certain stimulus or stimuli and certain placements of the stimulus or stimuli. As the practitioner gains experience in diagnosing the impairment and the effective mediation for each category of impairment, the reiterative process becomes more directed and efficacious. For example, in the case of impairments related to balance control of the torso, use of the apparatus, namely small body weights strategically attached to a Velcn receivable garment, has led to an experiential knowledge database, that can be taught to others, mat impairment in one or more directions corresponding to muscle groups or to a portion of the proprioceptive system in the torso is often effectively mediated by weight placed on or in the location of the opposite on the torso on the muscle or at least to the overlying skin positions.

[57} Therefore , as another example, instead of stimulation by placement of small body weights, the attachment of selected subthreshold or threshold electrical, vibratory muscle activations of the torso skin, muscle groups by transcutaneous electrical nerve stimulation (TENS) or muscle stimulators using different signal protocols are used. I» another example, selective stimulation of different skin proprioceptive sensors, e.g. superficial., dermal, or suhdermal tactile, thermal, pressure, or pain sensors would be stimulated using any modality effective for acti vating these sensors. For example, a small lightweight patch of small nonpenetrating or.micropenetiating spikes, like a miniature bed of nails, pressed against the skin ^• using a tight fitting, compression garment or device, is used in place of the small weight ^• placement discussed above. Implantable electrodes or biodevices can be employed.

{58} instead of observing the responses to the stimuli by visual observation by a skilled practitioner in response to gross anatomical body perturbation forces, computer analysis and/or observation of EMG sequences and traces, similar to using . electrocardiograms for cardiovascular diagnosis, are employed.

[59] The responses of the brain and any selected, part of the nervous system may be detected in the above methodology by any modality now known or later devised, include ftmctionai MRS of any body part or electroencephalogram (BEG) of brain or electrical trace of CNS function. According to the spirit and scope of the invention, the number, and variety of stimuli that can be applied, their combination, their sequencing and formatting is nearly limitless. Similarly, the number and variety of sensing or observational modalities that can be applied, their combination, their sequencing and formatting is also, nearly limitless.

However, for the purposes of mis disclosure and clarity of terminology in the following claims, the term, "non-weight stimulus" and similar terms, e.g. ^il no.n. ^» weight.-based stimulus", is defined to include all forms and sources of stimuli perceivable by vision, smell, taste, sound or touch, and any equivalents thereto later discovered or developed, other man stimuli which arise from the use of a static mass ot weight applied directly or indirectly to the body or skin, including but not limited to a garment, appliance or device for coupling such a mass or weight to the body or skin. Thus, "non-weight stimulus" ½ to be understood as not including any apparatus or methodology disclosed or claimed in any of the U.S. Patents 7,156,792;

7,708,763; 8,215,773, or U.S. Patent Application 12/728,873, or in any divisional, continuation or currently filed coatmuation-part application related to the same under 35 USC 119, 120.

Correspondingly, the term "weight stimulus" and similar terms, is defined to include stimuli whic arise from the use of a sialic mass or weight, applied directly or indirectly to the body or skin, including but not limited to a garment, appliance or device for coupling such a mass or weight to the bod or skin. Thus, "weight stimuli" or "weight-based stimulus" is to be understood as including any apparatus or methodology disclosed or claimed in any of the U.S. Patents 7,156,792; 7,708,763; 8,215,773, or U.S. Patent Application 12/728,873, or m any divisional, continuation or currently filed continuation-part application related to the same under 35 USC 119, 120.

|61 J It is expressly understood that the entirety of the disclosure of US Patent

8,215,773 (hereinafter 773 patent) has been and is incorporated into the present specification by reference. Therefore, the illustrated embodiments of the present invention, is .incorporated into and combined in all of the embodiments in the ^* 773 patent, ft is to be expressly understoo that any mechanism for attachment of the devices into or on the garments or devices of the '773 patent is contemplated. For example, the entirety of the garment or worn device may be Velcro receivable so that the perturbing stimulator and/or corrective stimulator may be mounted, attached, positioned or disposed on the outside or inside surface of the garment or worn device or even within the garment or worn device at any, all or some positions or at a selected position or region on, in or within the garment or worn device. The temporary or permanent affixation on, in or within the garment or worn device may be by any mechanism or means now known or later devised, ineladiijg- but not limited to hook/latch, adhesive, welding, gluing, sewn, magnetic, riveted, pinned, bolted, belted, tied, strapped, laced, bound, snapped, connected, joined, any type of mechanical or electrostatic attachment, and/or mechanical compression by the garment or worn device. Accessory devices for recording or sensing responses or movement, or for powering the perturbing or corrective stimuli may be incorporated into the garment or word de vice, or carried in separately attached packs or belts. It is also contemplated that the garment, or worn devices will he combined with wirelessly coupled accessory apparatus used for the disclosed functioning, for example as may he included in wheelchairs, walkers, prostheses, orthotics or other collateral apparatus. Examples of some of the garment or worn device are shown in Figs. I - 38 of the '773 patent and described therein. The various garments and devices in Figs. 1 -38 of the '773 patent may be fitted with any one or mare of the non-weight and weight stimulators disclosed herein or with the integrated multiply stimuli stimulator of Fig. I . Thus, it is to be understood thai many of the garments and devices with which the stimulators of the disclosed embodiments are intended to be used or may be used are illustrated in the incorporated patents, and in the "773 patent in particular. Regardless of how the perturbing stimulus and corrective stimulus is coupled into the patients sensory or nervous pathways, it is selected and applied as determined by the

observational and/or peitorbative reiterative diagnostic methodology of the invention.

\62\ Each patient or individual is different than each other patient or individual

Therefore, other than in very improbable and limited circumstances will the application of perturbing and corresponding corrective stimuli be exactly identical for any two patients or individuals. Just as each patient or individual has a unique set of fingerprints, so each patient or individual has a unique corrective set of stimuli that is optimal or effecti e with that patient or individual, Further, as the patient's or individual's brain learns to compensate for any

dysfunction using the corrective stimuli, the application of the corrective stimuli may or will change over time. The diagnostic-ally determined corrective stimuli needed may change m time even if there is no. disease progression, that changes the- nervous system pathways, because of brain adaptation.

{63] Further, wherever the term, "body" is used, it is to be understood to include the whole of or any portion of the body, such as the head, torso, limbs, skin, neck, hands, fee t, or a sensory organ or sensory system of the body including vision, smell, taste, sound or touch, or any in ternal portion of the body.

\64] Many alterations and modifications may be made by those having ordinary skill in the art without, departing from the spirit and scope of the embodiments. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken a limiting the cnabodimeBts as defined by the following embodiments and its various embodiments.

{65] Therefore, i t must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood thai the embodiments includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially clsimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the embodiments is explicitly contemplated as withis the scope of the embodiments..

|66J The words used in this specification to describe the various embodiments are to be understood not only in the sense of their commonly defined meanings, hut to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.

[67} The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, hut aii equivalent structure, material or acts for performing substantially the same function in substantially Ac same way to obtain substantially the same result, in this sense it is therefore contemplated that an equivalent substitution of two or more el ements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as .such, it is to be expressly understood that one or .more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a

subcombination,

[68] Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being eqtiivalently within, the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. f<$| The claims are thus to he understood to include what is specifically illustrated and described above, what is eonceptioraliy equivalent, what can. be obviously substituted and also what essentially incorporates the essential idea of the embodiments.

20

21

FIG. 3C

FIG.4A

FIG.5B

25

26

27

29

SUBSTITUTE SHEET (RLILE 26)

FIG. 10B FIG. 10C

SIDE VIEW

FIG. 10D

32

33

FIG. 12A

Flfi 1 0R

FIG. 13B

FIG. 14A

FIG. 14B

ADDING COOLING COMPONENT:

COOLSTRiP

FIG. 15

FIG.16

^" IG.17

FIG.1 SB

FIG.20

41 RECEIVABLE WAIST

FIG. 22

FIG. 23

FIG, 26A

-IG.26B FIG.26C FIG.26D

"IG, 27

45

FIG.32

FIG. 33

•3305

FIG, 33C

) ) 330?

^~ IG. 33D

48

49

50

51

52 US 8,215,773 B2

2

E iirriiSG GA M TS A » ORTHOTICS t¥iietioti, ability ¾> control em'» COG over their base of

FOR IMPROVING BALANCE support, weight shifting, equal weight bearing, vision, cog* ration, and equilibrium. Alterations in input, and output sys¬

CROSS REFERENCE TO RELAi ^' ED tems vary with. age. with the type ami severity of the neuroAPPLICATIONS logical problem, and with the severity of any resulting neurological degeneration.

This application claims priority &> U.S. Provisional A pliProper eoo i nation of posture and movement rely on the cation Ho. $1 325.981, filed Apr. 20, 2010, ttw eorhents of body's ability to initiate and effect subtle postural adjustwhich sic incorporated herein by reference. This application ments, for example, one's ability to remain iu an upright also claims priority to U.S. Provisional Application No. position while gifting or standing is fundamental to safe and 61/236.029, filed Aag, 21. 2009. the coment» of whs* are efficient movement. Similar! , balance control -while walking incorporated erein by reference. requires proactive control of upper body stability i ts both the

This application has subject matter refeted to U.S. appliea- sagittal frontal and transverse planes, as well as the coordiBtra to. No. 1 1/565,207, filed tin Nov. 30, 2006, now U.S. nation of the upper and lower extremities. Such control is Pat. No. 7,708,67 , whkb is a corttinoation of U.S. patent often compromised tine to various neurological disorders and application Set. No. 10/353,539, filed on Jan. 28, 2003. now

aging, Correction of aberrant balance is often complicated by U.S. Pat. No. 7. 56,792. VS. Pat. Nos. 7,708,673 and ?.15 ,

(he biomechanics <>f certain movements,

792 are both incorporated han-m by reference,

I ^' - ^' of example, two-t&irds ofa iititnt t's body wetg i is ceniNCO IO HON BY KBFERE Ii tered in the upper body (head, torso, and arms). When the body mass is not neutral, or is off-center, the center ofgmviiy

Ail publications end patent applications mentioned in this js not positioned over the base of support- This is simply a srsecilkation are herein incorporated by reference in their natural instability doe to the anatomy of a human being. entirety totbe same extent as ifeac .itnlividiwl publieaiiots or However, when a person cartuot maintain contxol over this patent application was specifically and individua 11 y indicated natural instability, decreased ability in function, cognition, to be incorporated by reference. cootdination, balance, ambulation, vistoji, and e¾uilibriuni tend to occur. To ameiiorate and/or eliminate this instability

FIELD and facilitate better movement, I Isave found that pjoviditig certain couater a lances and proprioceptive enes to a person

Described here- are weighted garment devices or orthotics, having such ptoblem tends t ovwomte upper body instasystems for making and using them, and methods for providbility and allow improve fimctioti of the above-meniioned ing a patient im'itsga balance disorder, or proprioceptive loss, sysien-ts,

with & weighted garment or orthotic device tending to

improve the patient's balance. Garments and other ev es SUMMARY

produced using these methods are also shown,

The ^r esent invenfion relates to ttdjtmabJe balance eva!a-

BACKGROUND atioti pnnents, tnetliods oi ^' osing ihetn to detertniaB where on the garment to place a weight to enhance a subject's stabilit ,

Many individuals suffering from tsenrokigk-ai disorders, customized adjustable and. noti-adjiistahk> garments to balance dysluticikm, difficulty with weight shifting, and l ss enhance balance, and methods ofn tang evistointzed adjustof proprioception, have problems maintaining their center of able and!ion-adjttsitsbie gisrments to enhance hakince, vision, gravity ("C ⁽ Xi") over their base of support, die perimeter and equilibrium.

defining the contact region surrounding the feet The inability For example, described herei ti are raelnods of making cus* to maintain one's COG over the base of support results in ttaiyi¾idnon-itiljttstabie gannenis or orthotics comprising the decreased postural and motor control in sitting, standing, steps o : placing a first weight on an adjustable balance evaluchanging positions, and locomotion. N-femtettiin.ee of the ation garment to determine where on. the adjustable balance COG over the base of support is desirable for smooth and evaluation gai-nieiii to place a weight io enhance, the subject's coordinated tiiovemetii iti balance and pit; stability; and securing a correspoiKiing weight to a customi¬

The ability to maintain COG balance over the base of zable garment tn the position identified from the adjustable support relies in. part on three input systems: the somatosenbalance evaluation garment . The weight contbinaijeii may be sory (proprioceptive and tactile input from ttte torso, feet, and less tltit!) 2% of die subject's body vveight,

ankles}; the vestibular (spatial orientation and balancing in some variations, the weight is permanent ly seemed to functioning); and the visual (input from sight), When a probroe eBstettaiabie ga ment, foi example, the wesght may be lem occurs in one of these input systems, it may affect both sewn to the fabric of the garment or sewn within the garment, the input to flic sensory integration system of me centra! or the febric may be secured to the garment so that the !abric nervous system ("CNS") and th resulting ability to use the itself may provide theweigiit (i.e., weighted or heavy ttric). remaining one or more of the somatosensory, vestibular, or Also descabed herein arc custome non-adjustable visual input systems for balance. The-CNS may then tend to orthotic g nrtejits for improving the balance of subject ior rely more heavily on one input system relative to another, or whom the garment is tuade, die garraent eomprismg: a gareven ft» rely on ether areas of the nervous system itself. ment body conii RFCd to be woai by a subject; and a weight Changing the input to one system may allow another system secured to the garaiem body i« 8 position that is not symmetto foiicttotJ normally. ric relative to the subject's body: wherein, the weight corre¬

The nervous system' s reliaaee on other areas of die MS to sponds to between about 0.2% and 2% of the subjecf s body compensate for the deficiency of one input system can lead to weight. The weight may correspond to between about 0.5% nervous sysem faligue. In addttiott, problems associated with and about 1,5% of the subject's body weight, lite garment inefl ^' eetive or inaccurate input or output tend to affect motor body may be configured to fit over the subject's torso or other control, speed, movement coordination, automatic postural body part. In some variations, the garment body is coafigured US 8,215,773 B2

3

a s m, und«$an».ent, ^' Π» garment body may fee configured to upon the weighted garment or orthotic. These methods may be wont a head or limb or as a vest, shirt or jacket. be manna!, e.g., observational, and/or to some degree com¬

Aiso described herein are adjustable balance evaluation puter-assisted. Video recording equipment or other electronic systems fax aligning a patient's ("patient" and "siibj ct" arc equipment may be used.

used interchangeably in this disclosure} COG over their base For example, these me hods may comprise the steps of of suppo t, the system eotnptisMtg: a belt st a configured to observing a paiieiti's ability to maintain their C G over their attach a wight at a rt^-predeferrnined postfioK along the base of support, optionally perturbing the patient (e.g., by length of the belt strap, wherein ihe belt strap comprises applying an externa! push or by having the patient try to resist markings to indicate the location of an attached weight; a the movement force, etc.) aad observing their body's reaction shoulder sirap configured to connect to the belt sirap, wherein lo the perturbation, selectively weighting the patient's torso, the shoulder strap is eotifigared to attach a weight tit a no»- head, or limb, and observing the patient ^' s ability to maintain prcdetermincd position along the length ofthe shoulder strap, their (XXr o er t eir base of sup rt alter being weighted. further herei a the shoulder sirap can . hoi need not, comprise Additional steps ma include tetnnostriry reducing or elimimarkings to indicate the location of an attached weight; and a nating the patient ^' s vision and observing tie yaiieafs ability repostitotiable weight configured to be positioned on the to maintain their C<X j over their base of support, and recordshoulder strap or bel t strap, whereto the weight cmehittatraa ing the position and value of each weight secured to the is ^' less than about 4 pounds. The system may also include a garment or orthotic. Any or all of the steps may he repeated as weight packet lor holding the weight a d attaching to the belt necessary. In addition, these methods may be computer or shoulder ste . So some variations. She system also includes assisted.

a clip fox attaching tc> the end f the shoulder strap and The present invention includes weighted garments or coupling the strap lo the belt strap. orthotics, typically produced using procedures described

The system may include a pair of shoulder straps. Alternahere. These garments or orthotics may take on any number of tively, the shoulder stra may comprise a back strap aiid a pair confi ttratioas. The gaanefii or orthotic may be a vest, perof front straps extending from the back strap. The belt strap haps having at least one pocket for receiving and securing a aad the shoulder strap amy comprise a Veiero-fype t ack* weight therein, or may have a plurality of pockets. The pockmeat material. ets may be distributed ftroughotrt the vest in a plurality of

The reposuiotiable weight may be less than 4 pounds, less orientations and have a plurality of sizes. The weighted garthat) 3 pounds, or less than 2 pounds. In some variations, a ment or orthotic ma also be a head piece, cottar, brassiere, plurality of repositionab!e weights may be used. corset, shoulder pad, belt, seating device to be used in com.-

Also described herein aw; adjustable balance evaluation binnfionwitlia wheelchair, lee shirt, body suit, undergarment, systems for Pi ing a patient's COO ov r (heir base of supor combination thereof. Fm&tfcsiaJjy, ihe weighted garment* port, the system comprising; a belt ste configured to attach are of .a tint), ska, shape, and thickness, suitable for correcta weight at a non-predetermined position along the length of ing, assisting in or alleviating at least a portion of a patient ^' s the belt strap, wherein the belt strap comprises markings to balance dysfunction.

indicate the location of an attached weight; ami ;t plurality of 1¾e garment or orthotic may liave pockets, receptacles, or repositionable weights configured to be posi ttoned on. tire belt tubes for placement of weights therein or thereupon. The strap, wherein the weights are less than about 3 pounds. garment or orthotic may be weighted in ;t distribution pattern

Aiso described, are adjustable balance evaluation systems determined by the methods of the present invention, or the for aligning a patient's COG over their base of support, the material making up the garment or orthotic may be the system comprising a wearable garment having a weight weighted medium.

attachment surface configured to attach a weight at a aon- One garment of particular utility is a coat, vest, or shirt predetenirified position on the weight attachment surface, constructed in such a way that it. has a number of elastic tabes wherein the weight attachment surfaces comprises markings situated along the body when worn. The tabes themselves to indicate the location of an attached weight; and a plurality .may ha e openings at each end and at points irHssrmediate in of rep sitionab!e weights configured to he positioned on the the tubes for introduction of weights or stinmfi at various wearable garment, wherein the weights are less than about 3 positions within the tubes, Other garments of interest ^' include pounds. The wearable garment may be configtired as » shirt, undergarments such as brassieres, corsets, shoulder pads, vest, or jacket, in some variations, the wearable garment is belts, seating devices and the like that, if desired, may be used configured as a cap, headband, or bat. in combination with a wheelchair, see shirts, undergarments,

Also provided herein are methods and devices for assisting body suits, and combinations thereof

a persofthaving aba!ance disorder inneedof suchassistana*, The apparatuses, garments, and orthotics of the present or ior aliping a per n COG over their base of support disclosure can also include tine, two, or moss than two relabiaoieehaoiciilly or proprioceptive!)- (e.g.. by receiving tively rigid insert; that support the bacL torso, or neck. An stimuli originating in muscles, tendons, and other internal insert can be enclosed in a pocket on the back of tire garment. tissues}. Iroprovemeats ¼ the ability to think (cognate), see, The pocket can be sealed by a variety of ways, including, but use eyes, sit, grand, tuna, walk, shift wetghi, eoonliiiat , and not limited to, hook and loop materiaL buttons, app rs, and balance may be achieved. The methods and apparatuses the like. Ihe garments may be of unitary design or be made of described here are suited to individuals suffering fisom varitmt!tiple. components. The garments or apparatuses can also ous neurological disorders and orthopedic conditions. For include a belt. The belt can wrap around the outside of the example, persons suffering from cerebellar degeneration, insert through openings in the garment or apparatus. The belt Piirii-inion's disease, multiple sclerosis, age-tejataddegenera- can also include another insert.

live disorders, stroke, traumatic injury to the head, brain, or This disclosure is also directed to methods for improving a spinal cord, orthopedic injury, aad cerebral palsy, ma benefit subject's vestibular system, hi these methods, a subject's from my described methods and apparatuses. vestibular system is initially evaluated. Next, the subject's

Oat ¹ described method provides an assessment of a vestibular system is stimulated by one or more weights or patient's ami for a selectively ei hted garment or orthotic stimuli on the head, neck, or torso. Then, the subject's vestiand for determining the proper weight placement within or bular system is evaluated again. If, when compared to the US 8,215,773 B2 initial .valuation of (he vestibular system, the «»1¾« t*s ves - perspective views, respeawel , of one vanatioftofa fe-teaer fibular system does not show improvement, the- one or more that may be used to link the straps (e.g., PIGS, 808I>) to the stimuli an&'or devices appited to the subject's vestibu lar sysboll portion (FIGS. 8A-8B).

tem can fee adjusted or added to- These stops of compar ing and FIGS.9A and 9B show fiont aad back views, lespectiwj , adjusting or adding to the one or more stimuli o devices are of a portion another variation of an adjustable balance evalurepeated until she subject's vestibolars stian shows improve* ation tool

meat when compared so the itiiiiii! evaluation. F 10. J OA shows one variations of portion of aa adjustable

This dis losure also includes methods and apparatuses for balance evaluation tool, winds .may form part of a strap or improving a subject's vision. The a aratuses em include bolt, PIGS. 10B and IOC show side and hack perspective eyeglasses or eyeglass frames that can be weighed, symviews, respectively, of an adjustable-position weight for use metrically or asyrmneirically. la these methods, a subject's with the tool shown in FIG. 10A. FiG. 1#D illustrates a clasp vision is initially evaluated. After the initial evaluation, a mechanism for use with the too! shown tn FIG, i OA. person's vestibular or ocular system is stimulated by cine or FIG, 11 A shows one variation of an adjustable balance mm stimuli or devices, such as by providing weights on or evaluation tool, including a support region.

within eyeglasses or eyegkss frames, or via application of PIG. TIB shows ano&er varkuon of an crijusmble balance stimuli io the torso.. If, when compared io the initial evaluation evaluation loot similar to the variation shown in PIG. HA. of tiie subject's visioa, the subject's vision does not show PIG. I -A shows a schematic of a support region tor use improvement, the one or more stimuli aad'or devices applied with an adjustable balance evaluation ¾>ol.

io the subject's vestibular system can he adjuste or added to. PKJ. JZB shows one varitatioa of an adjustable-position These steps of comparing and adjusting or adding to the one weight for use with the tool shown in FIG. Ϊ2Α.

or more stimuli or devices are repeated until the subject's FIGS. 1JA and ISB show front aacf back views, respecvision shows approvement when compared io the initial tively, of tffl adjustable balance evaiuation tool configured as evaluation. a bra.

Other features and advantages will become apparent fam FIGS. 14A and 14B show front and back views, respecthe following description, drawings, and claims. tively, ofaa adjustable balance evahiaiioti tool ctmiigxtfcd as a vest.

BRIEF DESCRIPTION OP THE DRAWINGS PIG. 15 is an adjustable balance evaluation tool including a cooling cosnpoReai .

FIG - 1 provide a general flowchart of a method of weight - PIG .16 is an adjustable balance evaluation tool in conjunctag a garatein or orthotic to improve a user's balance. tion with gasmen? shell, configured as a shirt or jacket.

FICrS. IA and 20 provide front and hack panel views, FIG. l7 is.:H.wfheTV;iri3tit)nof;tn;k !isfabki ba.iiit)ceevaltt-- ation tool configured, as a yoga gai'meui,.

respectively, of an illustrative vest thai may serve as a

weighted garment or orthotic. PIGS. ISA and ISB is another variation of an adjus!abfe

balance evaluation tool configured as part f« hospital gar¬

FIGS. tttroagh 3C illustrate a conipnter-assisted

ment,

weighted- method,

FIGS.4A through 4C show a weighted shirt having longitudinal wises for the introduction of weights,

FIGS. 5Λ and 58 illustrate garments having slits for the

introduction of weights. FIG. 5C illustrates a garment configured as a belt showing a weight packet that may secured

thereto.

PIGS. SA and f>B iiiiwfcale to effect of weighting on a

patient, in PIG, 6A the pafieef is unweighted. witiJe ia PIG.

f>B the patient is wearing a weighted garment as described uied as ;t collar. FIGS. 26B-.2(>D tl istrate variatiots of heroin. weights and weight packets that ma he used with the

FIGS. 7A-7E show variations of an adjustable balance weighted collar shown in PIG, 26A,

evaluation tool (garment) which includes t wo or more straps FIG, 27 illustrates another variation of an adjustable baland a waist point. PIGS. 7A and 7B show variations from the ance evaluation tool configured as a. belt.

fat, and FIGS. 7C-7E show variations from the back. PKJ.2«A shows aa adjustable fcaiaj-ceeva!eation tool con-

PIGS. KAaitd SB sham the front and back, respectively, of figttrai as a hat or cap. FIG. 2KB shows one variation of an one variation of a belt for use as (or as part of) aa adjustable adjustable-position weight foruse with the adjustable balance balance evaluation tool, evaination loot showa in FI . 2¾A.

FIGS. 8C and 8D show (he f ront and back, respectively, of FIG. 29 shows another variation of as adjusiablc bahioce a torso strap ponton of an adjustable balance evaluation tool, e ¾h:3s«i¾j tool con8goroiJ as a cap,

whichraay be used in conjunction with thebett ortion shown PKJ.30 is at) adjustable balance evaluatiou twl configured in. FIGS. SA-8 . a ii citif o bKtceJet.

FIG. SB shows one variation of a weight packet, as FiG, 31 is an adjustable bal ance evaluation iool configured described herein, nd PIG, 8F illustrates a weight which may as a show.

be used with such a wei ht packet.

PIG. St -, shows another variation of a weight, i which the

wesght ujcSitdes aa attachment means (e.g.. securely attached

to the weight).

FIG .dH fcsa genericexarapie of a lasener that may be used

with the adjustable balance evainaik» tool (system) shown ia

FIGS. 8A-8D. and FIGS. 81 and 83 show ^" faint and back US 8,215, 773 B2

7 8

PIGS, 34 M to® various views o f ^' additional m*bod»neitts site and comparing it to a comparable COG before thai treatincluding a relatively rigid support component. ment step. Depending upon the malady and the patient, the appropriate- treatment, may result iti placement of a weight on

DETAILED DESCRIPTION the side of the patient considered likely to m ve the COG further toward center, biomecksucaily or p«>priocepti vely. inscribed erein are methods for memag a need for a Ass shown in PRi. I. the iirsl step 1M is an initial observaweighted garment or orthotic and for otaermirting appropriate tion of the patient in this step the patient's physical orientaweight and weight placement w ifljirj ihc garment or orthotic, tion is observed. This usually inv l es observation of the in addition, described herein are tools for performing these

patient while stHitig or standing, white the pravkfcrobserves methods, including adjustable balance ev luation took de- so

the patient's frontal, sagittal or transverse plane orientation, vices and systems). Aa a justable balance e aluat on tool

as well as bodily movements and balance dysfunction cues. may be a weighted garment or orthotic. Its s me variations,

The sagittal plane refers to the imaginary vertical plane the adjustable balance evaluation tool may be tised to create a

therapeutic device such as a weigh ted garment or orthotic that through the body that divides the body into equal left and right is not adjustable, lite methods described herein may ran- t ha m. The frontal, or corona! plaae, refers !o the imaginary Oitsiy he .tnamtai, computer-assisted, or LXaiibinatiotw of the plane through the body thai separates the front from the back. two. For example, during observation, the patient may first be

Making reference now to (he drawings. F !G . l is a general observed in a sitting orientation. The observation tuny involve li ev iiiw of a method for assessing a .need for a weighted the exploration oilbllovvingcjuestions: 1 ) fetbe patient able to garment or orthotic and for deteraiiniBg an appropriate 2 sit upright without support?; 2} if the patient is unable to sit weight aatU eigtii lace nt within thai garment or orthotic. upright without support, which way does (he patient tend to

In general, these methods roske use of body positioning fall or lean?; 3) is the patient sitting with their body positioned art ! perturbation leehttio-iies to detect biilaitce dysfunction. in the inkliine of the coronal and sagittal planes?; 4) which When a balance dysfunction is identified, the method of the way does the patient lean?; 5) wbaf happens to (he patient present invention ma be used to systematically and selec- 2* when t ^' bey close their eyes ie.g., do they lean in a different tively apply weight to the patient's torso or other body regaots, direction, sway mote, etc,}? If the patient: is xtmbk io sit 1 ti general a weight is selected for p iacement on or within the without support for example, or there ate other i nt!ications or therapeutic garment or orthotic. The size may depend on, cocs that the patient has a ixiiajtee dysfuaction, the selective inter alia, the patient's tolerance for the weight and their vveightitrg process 194 may begin.

ireatnwntneeds. Typically, the various weights applied to the 3» The patient mav also be observed in st ndin orientation. garment range ftom ¼ pound to 5 pounds for adults, or 1 For exatii ie, the observation may keoJve the exploration of than that for children, for example, Ί of a patient's body the follow ing questions: l i how does the patient get {com the weight. The determination of the appropriate weight may sitting to the stsatding positions (e.g.. is this movement fa ther be dependent upon on the patient's sixe, strength, and smooth; dothey use tlu"irhatKls _; ete)?'.2)eant{iepatietrt stand resistance to move the patient's ( )G to the center o I ^' fhe base 3-: j itiioitf Li.se of their hands'?: 5) how many attempts does it take of support. For example, the weight applied ma be less than the patient to stand?-, 4} how stable is the patient's initial 2.5% of the patient's body weight, ks* than 2% of the standing balance (e.g.. do they sway: how far apart are the patient's body weight, Jess than 1.5% of the patieiifs body patient's feei. etc. } ; S j eanthep fienf standsvia feet together weight, or the ^' like. These weights are generally much lighter without fitliitig?; 6) how many steps does it take ibr the patient, than weights used iu other therapeutic or exercise weighting lo bring the feet together?: 7) does the pattern litltcr while systems. For example, the weights used to achieve compresstanding?; 8) what happens So the patient when they close sion of joints (i.e., to get joint stabilisation) are typically their eyes (e.g., do they lean in a different, direction, sway much greater than the low pounds or less than four pound more, etc.). lithe patient is unable to stand without support, or weights used in the .methods, devices and systems described there are other indications- or cues that the patient has a balhere. ance cfysftinctioii, the selective weighting process 104 may i accordance with, the methods described iterei n, continbegin,

ued parturbiiHoa and balance testing is done isntii the patient The ohsarvatioa step 1 fid may also inclofle observation of resists t e perturbation or snows impro ement in control or gait. For esatnple, observation of gait may involve the explomovement compared (o the initi l observations, or (ideally) ration of the following questions: ! } is there n disturbance in evidences improvement in control end movement that cmmos the swing or stance phases of gnit?; 2) does the patient have be fiirtltenBaxiraixed.After an appropriate weight placement equal stride lengths?: 3) is there any hypenstension at the has been determined, changes in movement control, walking knee?; 4) does fh tsfienf sailftiieir iixit while they walk?: 5) ability, cognition, vision, or dizziness may be assessed. The can the patient walk a straight Jime?; $) does the patient lose patient may, during the procedu e, be asked about their ability their balance while walking (e.g., while walking straight, to tolerate additional weight and their overall comfort level forward, or titrolng, etc.)?; 7) How is the vestibular ocujor with the weighted apparatus, in this way the amount of system tonctioriing (e.g., how does the p¾ient:periorrf! when weight may be modified prior to the final preparation of the walking, and turning the head or eyes)?

weighted apparatus if necessary. In general, the observation may take any number of forms

In its Most elemental form, flits procedure is observatiotmS and includes all methods of observation useful in acquiring and heuristic. 11. is procedure does not necessarily rely on delta. For example, the observafitn step may take the form of specific balance standards for assessing the magnitude of a visual observation and may tnchide the tise of mechanical or patient's balance dysfunction {e,g. Berg; balance standards,

Tinetli balance standards, postttr graphy, etc). The a.tiwss- mem of a patient's improvement during this described procedure is by observation following the instructions

given here, or may be had by monitoring a patient's COG

placement after introduction of a specific weight at a specific US 8,215,773 B2

9 .1.0

This type of perturbation, testing is analogous to the perturFIG. 6.B, T e adjustable balance wahattioo tool in this bation testing done in step IH and will be discussed in greater example has two shoulder straps that attach to a waist hand. A detail below. weight may be secured in any position on this adjustable

That is, if after initial observation, no problem balance evaluation tool; in this variation one sttrfaceis a hook:

a material, which can mate with a hook material sec ured to the weight (e.g. , a Vefcro-typs interaction), M- ^' IG, 68 the patient is shown performing she same task (e.g., walking in a tandem stance) with substantially better balance.

In general, if an adjustable balance evaluation tool is used. so such as a vest, including the arments/s stems illustrated in FIGS.2Α-ΪΒ end FIGS. A-5C, the-weights may be placed hi any position on the adjustable balance evaluation tool, rather than pfe-detemiined positions. Thus, as described in greater detail below, the adjustable balance evaluation tool may allow is ibr weights to be positioned in regions immediately adjacent or continuously adjustable positions.

The weights may be flexible or rigid, and have any given thickness. The garment (the adjustable balance evaluation too!) may be marked (e.g., on the pockets, receptacles or dysfunction." The patient may a o be subjected to a lateral 2 surface of the garment receiving tlte weig (s) to allow recorperturbation, wherein a force is directed laterally thr h the dation of the weight placement For example, pockets or humerus at the top of the shoulder joint to displace the patient, receptacles may be numbered, or may be designated, with sideways, t:o the fight or the left. lithe- atient fail sorts unable alphabetic ch acters, sym ol^ pictures, figures, or any comto resist the perturbation, this is termed a "lateral dysfuncbinations thereof. Thus, pockets of an adjustable balance tion," Each of these dysfunctions may further he classified as 2* evaluation vest may be numbered and the method ofweight- "to the right" or 'to the kit" based on the direction the patient ittg the orthotic tdeattikd t d results recorded using a numis unable to resist the peitsrbation. bering system. Aherttatrveiy, recoitlttiioti of the weight .piace*

The patient may also be subjected to a totational perturbauieat may be :caade oa act exmea form or sheet.

tion, in right rotational perturbation, the right shoulder of The method of weighting the patient or the orthotic is often the patient is pulled forward and the left shoulder is pushed 3 dependent ott the specific type of patient dysfunction identic hack. Similarly, ¾a a left rotational pemtrbat ioa, the kit shoullied ariitg bservatioB step tt¾ ⁾ aid perturbatk)» testing 116. der of the patient is pulled {forward and the right shoulder of Refe.tBts.ee -will now be tnatie IOFKJS. lAattdiB, which show the patient is pulled back. If the patient exhibits less control front and ha ck views of one wia i ton o fan adjnstabl e bal ance over their right shoulder being pulled forward than their left evulu;tti(?i) tool that is configured as a vest . Again, this vest is shoulder, this is termed a "right rotation dysfunction." Con3-: a garment that tfsel may be tisedeither as attend product (i.e., versely, if the patient exhibits less control over laeir left u garment to be wont by the patient) or as a tool to detenni ne shoulder being puHcd forward titan their right shoulder, this is tlte placement and size of weights to be introduced into termed a "left rotation dysfunction." another garment, perhaps having greater aesthetic appeal.

However, as mentioned above, ifduringobservation Ιθβ, a Other test garments may be used in the same way. For problem is detected 1 ⁽ 12, selective weighting treatment 104 i instance, it is my intent that test gant'teats having the funcmay begirt. The selective weightin step 194 involves the tional abiftfy to hold u weight in a single position during, ibr placement ofindividaal weights on the torso to aid the patient example, perturbatioa afid bsdance testing, are included as in counteracting the displacement, of 006 over the base of garments suita ^' bleas test garmmts (adjus table balance evalusu p t via biomechamcal or proprioceptive input At this ation tools). For iastaaee, m illustrative garment for testing stage, any method aiay he used to place the weights on the 45 may etitaprtse, rather than a collection of pockets for ittckt- patient's torso. For example, the patient ntity be provided with sioit of weights, a tacky exterior <»· an exteriorhavmg Vekro, a vest or other garment, or the weights amy be placed on the. or aaofiwr utethod capable of holding a wetght in position. patient's torso through any oilier metftod. The right side of tlte vest, white mint by the patient, is

If a vest is used, for example, the vest may contain a indicated with an R, Sitailarly, the left side of the vest, while number of pockets or receptacles for receiving weights. The 5ii worn by the patient, is indicated with an L.

vest .may contain, a plurality of pockets, having various sizes As nteatkwed above, adjttsiable balance evaluation tools and orientations, in this way, weight placement alon the inelnding those mat include pockets or channels for placing torso's superior, posterior, lateral or anterior diteciions, or weights, typieaOy allow positioning: of the weight in any any combinations thereof, may be assessed. appropriate position across a broad regtott of the adjustable

In practice, the methods described herein have shown 3.1 balance evaluation tool. This raay be contrasted with, garremarkable success. For example, FIGS. A and SB illusments ittcittdtitg piedetermhjed pfecement locfitiotK for trates a patient witii multiple sclerosis who experiences difweights ^; , tn contrast to the gtmnents described and illustrated ficulty in balancing before (FJO. 6A) arid alter (FIG, 611) herein, these garmenfs may have substant ial spacing between weighting as described above, in FIG, <SA the patient j s asked locations of the pockets, which would require weights to be to perform a tandem stance walking behavior (e.g., walking w positioneti securely only in these praletennuied locations. toe-to-toe) while balancing herself. During performance of For esaiBple. in PIGS. 2A and 2B, the adjustable balance the task her she ha difficulty maintaining her balance, resultevaluation tool is configured as a vest includiaga plurality of ing in rapid and erratic arm swinging, as illustrated. After pockets Chat arc imme iatel adjacent to each other across the detemtining the positioning and weighting, as described surface of the vest (e.g., pocket 19 is immediately adjacent to above, she was provided with a single ¼ !h weight located «j pockets 14-1*, 18, 20, and 23-23), In otiter variations die near her right shoulder blade, on the back of an adjustable entire surface allows ii>r she device to be weighted in any one balance evaluation tool worn over her torso, as illustrated in of an essentially coainuous (rather than discrete) locations. US 8,21.5,773 B2

11

Adjustable balance evaluation, tools having pockets therefore

do not include substernal (if any) spacing between adjacent

pockets, as shown in FIG. 2.

Illustrated below are examples o how a vest may be selec- tively weighted. a

Postetior Balance DysftsKiiou, To test For appropriate

weight placement with this A'sfao fiat). a series of weights

from i to ¾ pounds may be placed within any of pockets

1-11 until the desired weight shi ft orperiurbation resistance- is

achieved for adults, in children, the weights may be VV,. v¾, so

Vis, or ½ pottnds. Pockets 1-11 tav n the front of est 104,

Placement of weight may begin with packet 4 nd continue

progressively to pockets 8 and 9 it determined necessary.

Directioaajly, } have found mat begjajiiag the testing

sequence it ι the middle of the vest, e.g., pocket 4, progressing t5

downward to pockets 8 aad *!, and then to the left and righ

pockets is a practical progression for this balance disorder.

Additional pocket combinations .may then he added ntitt! the

desired weight shift or perturbation resistance is obtained.

The chaired amount of weight shjltorpetturhatkm resistance 2o

will be that amount resulting in m acceptable love! of

improvement in bitlun.ee or movement from the baseline

observation and perturbation steps. Once the desired weight

shift or perturbation resistance is obtained, the weigh): place- nient (e.g., the amount of weight placed within each pocket 2?

and the eorrespotidiitg wcight-pockct location) may be

recorded.

Posterior Lateral Balance Dysfunction to the Left. For this

malady a series of weights from ¼ to ½ pounds tnay be shift or pertnrbatfon resistance will be thai amount resultin placed within any of pockets .13. .1, 3, 4, 6, 7, or 8 and 5o in an acceptable level of improvement in balance and move- ct'iabinations thereof until the desired weight shift or perta- meat from the baseline observation aad p ttmtatioti steps. I basion resistance is achieved for adults. In children, the have fount! that banning weighting on thettpper. tei ^' i, front, weights tnay he ¾«. ½. ¼. or ½ pounds. Directional!)-; I have side of vest 104, proceeding down the front of the vest, profound thai initially placing the weights higher OR the body, eeeding to weight the -upper left side of the back of the vest, mid then adding or subtracting litem lower on the body, is a 3-: and then proceeding down the back of the vest is a practical practical progression for this malady. The- desired amount of progression for ibis dysfunction, In some instances, it may be weight shift or perturbation resistance will be that amoun desirable to provide even weight distribution between the resulting In an acceptable level o irrnaweroent in balance or front and back segments of the weighting apparatus. In these niovement fom the baseline observation aad perturbation instances, weight may be placed, within pocket 5 counterbai- steps. Patients having greater lateral instability than posterior * aneed by weighs placement within pocket 19. Similarly iiistabiltty o«:«siona!ly may need a weight placed in a posfe- weight may be placed within pockets 10 or 11 eoonterbe!- rior right pocket, ( ^' e.g., 17, 21, 26, or 21) as well as a weight anced by wcigiit piaecBient within pockets 22 and 23 nspee- placed in the front. Once the desired weight s ift or pertnr- tively. In some ttistances it may also be desirable to place a ¼ bation resistance is obbtined, the weight placement (e.g., the pound weight at the shoulder, for example- within pocket 12. amount of weight placed within each pocket and the corte- *s Once the desired weight shift or perturbation resistance is spending weight-pocket location) may be recorded. obiained, the weight placement (e.g., the amount of weight t¾sti>rior Lateal Balaece Dysftatclion to the Right. To test placed within each pocket and the corresponding weight* for appropriate weight p acentent tttr tins cH-sfntichon, a pocket location) may be recorded.

series of weights may he placed on the anterior left side of the Anterior Balance Dysfunction, To test for the appropriate patient with the occasions placement in one pocket in the 5ϋ wdglit placemen; for ih¼ dysilioetkit), a scri s of weights posterior left side of the patient when the patient has more from ¼ to ¼ ponncht may be placed w-itiiia any of <tckets .15, lateral d>¾fimction than posterior dysfunction. For example, 16. 19, 20.23, 4, 5, or 2ή, and ctanbinations fbereo iaiiii from ¾ to ¼ pounds of weight ata be placed within any of the desired weigh! shift or pertiirbatioa jvsistaace is achieved pockets .1.2, 2, , 5,9, 10, r 1.1 , aad contbitintions thereof utitil for adults, la children, the weights tnay be Vis, ½, ¼, or ¼ the desired weight shift or pertnibatiort resistance is achieved j.i pounds. The desired rnoont of weight shift or perturbation for adults. 1» cbildieri, the weights rosy be Y¼. ½, ½. or ½ resistance will bothas amouttt resu ^' ing in art accept ah te level pounds, lite desired aitioiutt of weight shift or perturbation of improvement in balance and tnovemart i m the baseline resistance will be that aoiottntresuitingtn anaceeptable !evel observation said .perturbation steps. Pockets 15, 1ή, 19, 2 ⁽ 1, 23, of mp«3iv¾meot io balance aad movement front the baseline 24, 25, aad 2b are on the back of vest 1*34 and a practical observation and perturbation sfeps. Once- Ihe desired weiglil: w progression, for weight piacejEoent may begin by placing shift or perturbation resistance is obtained, the wetgljt place- weights on the top portion of the back of the vest and then menl (e.g., the anioutit of weight placed withiii eaci) pocket proceeding downward. Io some instances, it tnay be desirable and the corresponding weigiil-pocket tocatkm) may be (e.g., a quicker determination of proper weight placement recorded. may be made) to place weights first within one or more of

Lateral Balance .Dysfunction to the Left. I have found that «j pockets 15, .16 ^' , 19, and 2<! helbie p!acttig weights ithin other even posterior anterior distribution of weights produces the ptKkets, if neeesstuy. Once Ihe proper weight shift or pertnr- best result unless the- patient has a mioor rotation, or bation resistance is obtained, the weight placement (e.g„ the US 8,21.5,773 B2

13 14 amot.tfii of weight plaeed within each, potion and the o e*- (*,g, ₄ is the dysfunction, in onl one plane ofmovsauaxt, etc), sp fli!mg weight-pocket location) may be recorded, and the patient 's inability fo attain or maintain C(Xi over the

Anterior Lateral Dysfunction to lbs Right. For im ropriate base of support,

weight placement for this dysfunction, a series of weights It ^' tSe treatment is ttot sueeessdai in that signiSieant l ir&er

US 8,215,773 B2

15 .1.6 will mevecloser to pesttfem 30», In (Ms way. the provider will shoe, gfovs, jacket, pants, caps, vest, or any other garment ta readily be able to detmmne whether, and to what extent, the be mm For example, desirable garments may be those speweight placement has caused the patient's COG to move cifically designed as imdergatnients, e.g., those typically toward center. FIG. SB shows another example of a patient worn substantially out of public view (depending of course, wbo is o IF center, [a this figure. nwk 30 indicates that the on taste) or 'intended to be worn underneath outer garments, patient stands posteriorly and thus ifee selective weighting such as shirts, Metises, axtd jackets. One variation speciiieaHy procedure may be anteriorly, However, it ^' should fce noted that include the nttdcrshirss, brassieres, girdles, or girdle-like selective weighting does not always begin at a position oppogarments mentioned elsewhere Of c urse, such mufcigar- site tiiat of the dysfunction (e.g.. weighting anteriorly for a itients may be made of fabric that is comfortable against the patient who stands posteriorly). These weighting starting skits, The garment may be self ^' -Fastenable (using, e.g., butpoints are Hierdy ilhis rative. tons, swaps, book and latch fabric sndi m Vekm aad mag¬

Once a patient has achieved improverac.su in C(X÷ over nets, etc.) or held to the torso using belts, bands, etc. base of support, or ideally, aritieved their optimal COG over The weights for placement within any of the weighted base of support, their ability to receive an interpret somaapparatuses raay be rigid or may be ilesible. The weights tnay tosensory inlormatioa, coordinate muscular contractions, be tnsdeofany suitable material, and be able to accommodate and move with more sta iiity may then optionally he tested. any thickness. When the weighted apparams is a body suit or The use of a computer together with devices for measuring brassiere, for example, the weighted material may be flexible, COG. e.g.. apliiKiiit afst!p x!rt sitditcesor loreeplates, may thin, and made of a liypoaiiergeate material. In this way the greatly ^U tatepmMsg^tMt^andt^in mamite tfoir eat! re sui f or brassier e may be made of the weighted materi ai , ways. For exati»pl , eoaiptfier assistance may facilitate having a weight distribution determined in accordance with qtneket determination of proper weight placement (e.g., as tbeabove methods, hi other variatiotts, the material itself may described above), as well as provide more detailed informanot be weighted, but may incorporate weights therein. Any tion, regarding a ttiDiifJCr of different patient positions. These suitable type of weight may he used. Tor example, in one positions may indnde, but are not limited to sitting, standing variation, flexible weights are used, of the type described in (on one or ^' both legs), bending, squatting, walkingup stairs, in U.S. Pat No. 6,<»S, ⁽ 1 to Cook filed on Nov. 9, 1995 and addition, computer assistance may help provide ntorc entitled ^* '.R«n£orc«l TiKnnoplastk fiiastomeric Gel detailed information on the patient's reaction while standing (RTEfi)." which is hereby incorporated by reference in. its on compSant and non-coiapliaai surfaces, such as floors, entirety.

rugs, etc. In this way. the testing of proper weight placement in other variations, the weights are provided in. packets may he rigorously evaluated while simnkifirtgany nuruher f having at least one hook and latch fabric, magnetic, or other conditions. easily attachable surface or portion. Thus, the weights may be

My invention also provides weighte orthotics or gartiisertediiiio a weight packet that is attachable to the gaiment ments. Proper weight placement and weight size or amount (e.g.. the adjustable balance evaluation tool). In this way, the are first determined using, the methods described above. Cusweights themselve may be attached to the apparel of the tom garments or orthotics may t hen be made to accommodate patient, for example, the weight packets may be attached to the patient's individual needs. IForexampie, ihepodfioit-tig of the watstlitie of a pair of paints, or ntay be attachable to a die weights and their actual weight values may be recorded portion of a shirt, jacket, belt, etc, iiui¾,dii3e.reji.tweigtiis.ttiaY using Hie procedures noted above and mapped onto a garment: be loaded into a atandanl-seee weight packet , In some variaor orthotic. For example, an adjustable balance evaluation tions, the weight packets may include one or more pockets for tool (system or device, including the orthotics or garments inserting one or more weights (allowing adjustment of the described) may be used to determine the correct positioning weight at a location by adding to the weight packet. One or and adjustment of the one or more weight* used. Similarly, both sides of the weight packets may kiehide a tastener (e.g., recordation of the actual weight values may help facilitate a snap, hook, etc) or adhesive materia! (chemical adhesive, reduction in the overall weight ef the g rment or orthotic by mechanical adhesive such as ho -asd-latch (i.e.. Ve-cro) making use of ratios. Once the location of weights aad their material, etc.), or the like, to secure it to the garment, in some values are recorded, tests may he performed to determine ¾ ^' variations the weights themselves areconlSgBred it attach to reduetumofalS or some weight values by a fraction wonldstilf the adjustable balance evaluation tool or garment. For produce ^' beneficial results in improving balance. La this way, example, the weight may include a fastener (e.g., snap, hook, for example, the amount of each weight may be reduced by a etc.) or adhesive material (ebemka) adhesive, mechanical fraction, such as V¾, resulting in ¼ weight reduction in each adhesive sifcl. as hook-and-iaiclj {i.e., Ve!eroj material, etc.), location. Ratios may also be used to faoiiitsi a reduction Hi or the )¾e.

the sfee of each weight. For example, the size of each weight I have fonnd an adjustable balance evaluation tool eoniig- may be reduced by a fraction if beneficial res As in improving ^' ured. as a weighted vest to be especially uscfnl. The vest laay balance are still obtained. have any imniber of optional psaeis, bat typically may have a

The garments or orthotics (including iitiiidjti.si.able balance pair of front panels separated by a front, closing seam and a eA^ua^tocrf nB b^<^a^a^o iaui fens, sim shape, back, panel or of eoinsw, it may be made up of: a from panel, and thickness, in order to accommodate the patient's needs a back panel, or side panels. Tie vest may be made of arty and the therapeutic weighting described henein. For example, number of suitable materials. The vest may be made of the orthotic may take die form of 8 weighted shoulder pad, a durable materials capable of withstanding the weight therein weighted belt, a weighted seating device to b used in com- and capable d ^' aiakiiaming its integrity intheeventthe wearer biaation with a wheelchair, e.g.. a weighte vest or other tails. The vest may have aconfinooush/ ;tdhesive sttrtace(e. ., garment thai may be attached (e,g., using Vekro or magnets) a VeJcro-type, iioiik-and-loop surface for receiving a weight to the back of a wheelchair se t to improve the patient's or weight packet) and/or ntay have any noxabcr of pockets or stability. » weighted attachment to a brassiere, a brace conreceptacles for receiving and se-cering the weights therein, as figured to fit a patient's torso, head, or body part, or any other described above. Alternatively, the vest may have no pockets weighted orthotic. Similarly, the weighted garment may be a or receptacles and be raamjiacttired in accordance itli the brassiere, tee shirt, bodv suit, belt, hat, headband, eyewear, above methods, wherein predetermination of the proper

SUBSTITUTE SHEIT (RULE 26) US 8,21.5,773 B2

17 .1.8 weig distribution is si k mi the mafcriid of the vest is need not be so. Other coo%iualj as are also suitable. f¾r weighted iji ccordiiticetliere vitti. For example, the vest may example, FIG. $C is another variation of an onho!ic device be made so that (lie weight is permanently affixed aid is not configured as a belt, as described above. A weighted packet readily adjustable after fabrication, based on lite determtna- 503 xaay be positioned and secured to the room, on!er, or tion of the weight location and amount made above. In gen- a either side surface of the device 501 by any ofthe attachment era!, such garments (cusfoaiked mid noii-iidjiistiibk' balance niec'baaisms descsi ! xl. The orthotic device s½wv.ii in. FIG.5C correcting garments) include one or more weights tbat are also illustrates .markings 501 uniquely indicating the position positioned in locations that are non-synwieiricol relative io of any attached weight packet 503, as described above, the body, but ate therapeutically positioned to correct or assist As mentioned above, the adjustable balance evaluation the balance for the individual for whom the ganne-nt is c«s- so tools described herein may also be referred to as orthotics or -ii!:. vj The weight is typically betweetj about 0.05% to less garments. These devices (which may also be sy stems includthat] 3% {e.g., less than 2%, m d 1.5%) of the subject's ing multiple components, as described below) may be used body weight. In some wtaiionsonly a single weight is used, during ihe testing/analysis portion of the method to determine and is secured on m asymmetric position n the garment where to post tioti one or m weights. After determining (relative to the subject's bilaterally symtnetry-"-t otrt back S where ihe weight or weight should be positioned, a separate and right kit symmetry). (e.g., ctBtomimi, non-adjtistitble) garment or orthotic may be

The vest may be of any length and shape to accommodate made usi og the infoniiaiioii taken irons the adjustable balance ihe wearer's height, size, body type., comfort, and ability to evaluation tool. ^' Tints, described herein is a method for creatmaneuver about while wearin it. Similarly, the vest ma be ing a customized orthotic that ma hjc lade the steps of using of any thickness so thai it may he worn it) any number of ways. 2 an adjustable balance evaluation, tool to detenuine the posiFor example, ia otic variatiravtbc vest is rehitivaly thin so thai: tion and weight appropriate so benefit a patient as described it may be worn underneath the wearer's clothing. In other above, then securing a corresponding weight to a customizvariations, the vest is thick, atid may be worn oft top of the able gsttneat in the position, ideniili&l Any appropriate garwearer's clothing. ment may be used. The weight may be pemiansntiy secured

Another weightable OS-weighted garment of particular use- 25 (e.g., sewn to the iabric or within the garment), oi it may be fulness is s twM ill FIG. 4A, The garment 400, although, temporarily secumi. In some v¾riat ats s pocket or altacli- shown in the form oi ^' a shin, ma he a vest, corset, or oilier tnent site is positioned on the jfarmeta at the appropriate apparel, ha ving at least a portion worn on the torso. Central to (cusioitt, paticat-specjftc) site so that the weight may be this garment 400 arethe lmrarencfosnres402 that are adapted attstchedi detached by the user. As mentioned mow than one io receive weights in shapes and forms that may be inserted 3» site tnay he used. Viiriasions inclutJiag attachment sites that into the to ene!osuites 402, Shown in F!G. 4A are linear are positioned by tlsis taethod may he coaiigared for «se with enclosures 402.haviri an.open upper end 40ή. cross-slits 08, 'weight ⁴ that are devices or objects weighing the same or less and open lower and 410. Each of the linear enclosures 402 than described that are not simply therapeutic weights but w uld typically have the <¾waings specified just above. achieve improved balance. For example, roe ^* wright' that

PIG. 4B shows a partial ose-up view of one o the linear 3-: may be attached «t me ctistota gannent may be a cold o.r hot enclosures 402 with the open cross-slit 40$ and the o en pack, cell phone, sensor, or other da vice, The aiJachniettl: site bottom end 4.10. FIG.4C shows a top view cutaway oi ^' a linear may be a pocket or r«gioo iticittding a fastener (or for mating: enclosure 402 and the open space 4.12 within lor placement of to a iiisfei ). In practice, the attachment sitefH ) for any paran approp i te weight. The linear enclosure 402 shown in ticular patient are specific to that paiieffi. and each gamiest FIGS, 48 and 4C is made up of a cover 414 that is surged to * may have one or more weights or attachment sites for weights the backing material 4W», at these spect!k sites, A custom garment may include one or

I have found that construct ing one or more o f flic cover 414 more weights (or an attachment site for a weight) that is and the backing materia) 416 from a stretchabie material such typically positioned on a discrete location (e.g., smaller than as nylon, Fyeni*. or the like, tends to hold the weights in 4.'.4 inches) iaau itsyimiicirie position. on the garment. For a position ia the linear enclosures, particularly if (be weights *s garment worn on the torso, the weight or attachment site may are resistatit to movement after placemen! or covered with a be located on the back, front, sksak!ers,, or sides.

rubber awiteriaf . Returning to F!G. A, the linear enclosures In some variations, the adjustable balance evaluation tool 402 shown there are positioned longitudinally wit the torso may be used, o:r adapted, for use, as a customized ganxient or of the wearer. However, they ne d not be so. Other wsiiigu- ortliotie, |¾r exanvple, once positioned, e v,¾ight ma be rai.ions, helical about the torso, of differing widths, as well as .so Lwistteviil attached to the adjustable balance evaluation single enclosures having varying widths, are also satiable. tool (raakiag it ii a-ad ssiybie}, or it may be attached to, or

Other useful weighted garments arc illustrated in FIGS.5.Λ viit itt. a porfi noi ^' tniothergannen!. For example, the adjustand SB. HO. 5A illustrates a weighted garment 500 configable balance evaitiaiioji tool may be coupled with a garment ured to be worn about both shoulders while PIG, SB illussuch: as a shirt, vest, bra, jacket, or ihe like. Examples of trates a weighted garment 510 configured to be worn about 5.1 adjustable balance evaluation tools adapted to be customised one shoulder. The ganiignis 5M and 510 may be doable garmeiHs or orthotics etc provtdef! in detail below (e , , FIGS. layered:!* example, and be made of a breathable and stretch- t.Vv2« .

able material. Slits 502 are provided variously along the FIGS, 7A to 7B show difiereni: variatiiMis of adjiisiabie length of the garments for the introduction of weights 504. balance evaluate! soofe or sysiems as described herein. For Slits for weights may also be provided oo the shoulder nor- example, FiOS.7A and 7B hew back views of two variations tints of the garments 588. The weights 504 may be held ia ofadj ostable balance evaliiiiiioa tools. In FIG, 7A, the adjustplace, for example, by sewing the weights in place at or near able balance evaluates) device includes a back strap 701 mat slit 502 or the wights may he allowed to migrate to the base connect to a belt region 700. The back strap 78.1 also connects of the garment 506 before being ssa ia place. In addition, (or is continuous with) two shoulder straps 703, 703'. one for any of the methods of attachment described above (e.g., hook «s each shoulder. The shoulder straps can thm pass over the and latch iabric, ma netism, etc.) tnay be employed hem hi front of the torst;, as illustrated ia PIGS. 7C" and 7F, and addition, while horizontal slits are represented here, the slits connect to the belt region 70S) on the front of the garment The US S _t 2 15,773 B2

19 20 stumps and belt .may he different compoesMts that nuns with lire straps shown in FIGS, $C and 8D are configured to each other, or they may be formed as a single garment. The connect to the belt of FIGS. 8A aad$B. Thus, the ends of the variation Aown in FIG. 7B includes lateral straps 70S, 705' straps 819, 809; 811 may foe coupled .securely to the belt. In that pas* under the arras and ver the shoulders, as illustrated general, an adjustable balance evaluation tool may be ctts- in FIG TO. ¾e«mfianrat«>nof the adjustable te^ a totnixtble to fit the torso of an individual by adjusting the a lion tool may depend on the patient. In particular, the con* length of the straps. For example, the ends may be cut or figuratfonmay depend ^' on the anticipated needs of the patient otherwise shortened and connected to a connector to couple based >ti w he re i t is aril i cipaied t I sa t wei ght s w ill be placed, as to the belt, FIGS. 8H-8J illustrate variations of connectors that may be included, as part of an adjustable balance evaki- described m the methods above, hi some pa tients more lateral

t ation system. A connector may be secured to the end 809, placement of weights is .necessary, thus the conhguration

11 of a strap, F orexaaspfe, the connector ma be folded shown iii PIGS. 7B and 7D may be mow appropriate, 809', 8

over the cut end of the strap (after i! has been cut io lit the

In all of the variations shown io FIGS. 7A-7B, &e straps

subject), and locked over the strap by a connector (e.g., fasand belt portions typically include one or mate axis of marktener), adhesive (Velcro, chemical adhesive, etc.), sewn, or ings, jncHcafing. where cm she Adjustable balance evaluation is otherwise secured. Hie connector may be a Mila clip, allowtool (relative to the patient's body) the weight or weight s are ing for customiztag of the length of the sttiips, and securing placed during treatment. For example, a ruler or calibrated them to (lie belt. The cottnectorinay include a hole or opening pattern may be termed m iite straps wtjdior belt- II» entire through which the belt is threaded, or it may .include a las- adjustable balance evaluation tool may be configured to allow tener. In FIGS. 81 and S.f. the connector includes an outer attachment of a eight or weights, for example, one surface 2 surface that, i s a Velcro material tlai can mate with the Velcro of the adjustable balance evaluation tool (the timer or outer receiver on the belt {at vice-versa).

surface) rosy be configured to alkw a weight to be secured FIG, 8E illustrates one variation of a weight packet 820 thereto. For exam le, the outer surface stay be a \¾lei¾ mateincluding a pocket 822 into which a weight (e.g., the wei ht ria] that is configured to mate with a Velcro hook material on shown in FIG. JfFjmay be positioned. The weight packet ma the weight, or weight packet. The markings along the adjust2* also include one or more sides configured to couple to the able balance evaluation too! indicating the position, of the adjustable balance evaluation too!, such as a fastener orVcl- weight may be on the same side or the opposite side of the cro-hool material. The weighs packet may be used with garment; (inside or outside). weights of a variety of skes, widths, and weights. More than

As mentioned, the adjustable iwlaac¾ waluationtool may one weight may be inserted or held by a weighted packet. actually be ait adjustable balance e aluati n system, tncltid- 50 FIG. SG is onevarintiono! a weight thtit includesa fastener on tag a pfctaKty of Kwieei i stra s thai are a apt d to attach one side (e.g., a Velcro hook tBaterial). Otlw feteae s .may to one or more weights or weighted packets, and include tticlitiie buttons, snaps, magnets, Ve!cro, atl!iesives (e.g., calibration marking uniquely identi lying the position on the glues), zippers, etc.

straps where the weight is positioned relative to the patient's As tnemkmed above, atsy appropriate weight may be used. body. The system may include one or more eights _* which 55 Fo example, the weight may be a mass formed of a meta l or may be directly attachable to the straps, or they may be user! other dense- materia! (e.g., lead, sfeei. etc.), a gel material, with one or more weight packets thai are attachable to the sand, reinlarcedt ennoplastic gels, magnets, pellets, rubber, straps. liquids (e.g., water), etc. In stane variations the weights are

For example. FIGS. 8A-8B and 8C-JK) show two compoeaiibraied to be of known weighi (e.g., ¼ pound. ½ pound, nents of an adjustable balance evaluation system, FIGS. 8A (i etc.), and may be marked. The wei hts may be for may and 8B show the calibrated inside and solid outside, respectiiclixfe.iffliigiiets for magnetically attaching to ¾e adjustable tively, of a belt stick as the ^' belts iterated in PIGS. 7A-7E. balance evaluation tool, hi some variations the weight is an The belt may include one or more surfaces that are configured active element such as an electrical stimulation .device, therto secure a weight or weights. For example, the belt may have mal device, or a vibration device, which may provide addj- a surface that is made of a Velcro materia! configured to mate 45 tional ilterapy or dierapentie benefit when worn. In sense <^ha Velctoh^imatetial. ^' RiebdtK reall adjustable so variations tbewe^ht is an element that is configured to .perthat it can fit a variety or range of wais! siss, and may be form an additional or separate function.. For example, the secured in place using a buckle, latch, or other material such weight may be a cell phone or other (nonnaliy) handheld as a Velcro attachment between the end regions, in PIG. 8A. deG.ee. ¾e weight may be a wallet orpoucb which may hold theitisidesuriiice oj ^' Ehebeit includes indicators fa numbering 3 ^; s additional material. In still other variations, a patient's sensystem that can be used on other portions of the device to sory s stem can be stimulated by c<!ropt¾ssion, hi sudivana- indicate position). FIG. SB shows an outside surface of the (iot)s, the stimttiiis ^' siitnulates a person's sensory system by device of FIG. $A, In this example, the outside sacked i» compressing a portion of the patient's body. Such eotnpres- adapted to secure a weight thereto, e.g., via Velcro. Thus, the sj(H). stitna!us can be provided by any of the apparatuses and outside surface includes a Velcro receivable surface, allowing 3.1 arincttts described hutdn. (¾tnpression can be provided «8. the weight to fee positioned an where the surface of the any body pan iecluding, hvst not limited to. a patient's head, device in a nofi-ptcdeiennitied manner, its outer variations the neck, ana, wrist, shtnilder, toreo, back, waist leg, hip, toot, outer surface is ceniigured t secure a weight or weights by a etc . The e ompressio ti can be provi ded by adj nstab ie bands or zipper, stay, track, button, magnet, or other .means. elastic material at desired locations.

FIGS. 8C and 8D illustrate one variation of straps which In some variations, the 'weight* m be a device such as a may be part of an adjustable balance evaluation system, la sensor or console for a sensor. For example, a controller or this ^; example the straps may also include a numbering system console (e.g.. Wii game controller) including motion and/or as illustrated tor the belt F i.8A), and one or more surfaces position sensor may be used as a weight or in place of a (e.g., the outer or inner surface*) may be configured, to secure weight. This may allow tracking or recording of the (XX} a weight or weights (either directly or via a weight packet). «J niovetnetii issteraciivdy.

The straps inthis example, include a hack portion 895 and two The adjnstable balance evaluation tools and systems over-slse-shoidder portions S'I7. 867', described herei n may be used ss indicated to help assess and US 8,215, ^' 773 B2

21 22 determine how to treat a balance disorder. In addition, to after passing tisrengh .the loop, as shown, ^' i e region marked providing weight as indicated above, these systems and "ί " may be ra ede o f < t s ire t e abi e Veler -ty pe receivi rig ma te- devices may also be used to provide additional sensory treatria! that is attached io D-rirtgs on the back (shown in FI0.9B). ment modalities such as vibration. eiaarte S stniirlatiori, or The strap cotdd also be made !othread tlmnig th D-ringand the iifce. The weight typically imparts a non-syremetrtcai s attach back to itself to allow more adjustment. The D-iingson force U) ilxe subject tiirougft the garment (based its posithe back may be pteotab!e to ailow adjtistnient of the shoulder tion) lo help stabilize the patient in need thereof, L« general, region. ^' The bnckoi ^' the device (region "S") makealso be made adjustable balance evaluation fools such as those described of a Velcro-fype .¾eeivirig tnatefial The lower back region herein (which may be- customized to fit and measure each ("7" and "8") are also made of an adjustable Velcrotype subject specifically) may provide many benefits. Since the so receivingntateri ai (and a region oi ¾k«5-iype hook roateiial} device may be cnsto iKe sad adjusted eOattrttKiusiy. the and can be adjusted to the stthject's height before attechii¾ to irtsurnctrtrnay b€o tiiiJ)zexf. ^' l¾ec]i:nieiatHSja use t(iedevite the belt, as dea-sibcii.

to assess the effects of the- treatment Also, as mentioned The example, shown above includes straps (shoulder above, aa adjustable s stem or device such as tiiose descri ed straps) and a belt, and the weight or weights are attached in. herein may be used to create, customized .aon-sijusisbie gar- S5 any (tion-predeteratixted) position using a Velcro-iype attachmeats or orthotics. ment. PIGS. lOA-lO ilhistrate another variiitioti in which

Aay of the adjustable bala nce evaluation devices and systhe ei lit or weights are attached to a track or strand oa the tems described herein may be Mly adjustable. Thus, these strap(s). For ex mple, FIG. 1 ftA shows a region of a strap for devices may be adjusted to fit multiple body sizes, ironr tali io belt) Tt ^' Wti that inehifks a central teener track 1 COJ to which short, large to rain., or the like.As described for FIGS. 8A-8D, 2 one or more weights may be attached (either directly or via a the straps and belt in state variations my be adjusted t» hi: weight packet). FIGS.19B aad tlius&tiiett weight ittclwl- different torso sires, trod the resulting device is easy to apply ing a coupling or fisstenin" region J ftS that attaches to the and may he lightweight arid fit aiiigiy. i addition, variations central fasteaer itaek 1¾01 so that the weiglit is held in place. comprising one or more straps may be comfortably wont, In this example, the coupling region is ;t clip-like structure since they cover only a portion of (he patient's bod , and do 25 that allows the weight to be secured itniler Ore central fastener not hind the patient's movements, although tbey may provide track ^' ίθβ ^' ΐ after .it has been clipped, on. Iti some variations the stability in multiple planes of movement . iti addition, these weight may be slid along the teener track i OI to adjust the de i es and systems may be quickly applied (and customposition of (he weight. For ^■ example, PIG .. 01) shows a partial ised) said may he wont by the patient over a l ng lime < e.g., side view through a fas!ener including a friction clip that may mirmtes. hours and even days). These adjustable balance κ> be released (e.g., by pnsMngoo one end ofardeose lever) and evaluation tools ffiay be i»,a-ohtrusjveiy worn beseaili other allowed to slide oa tlieeeittfai festener track or removed frotn. earthing, or over other clothing, as mentioned. the track entirely. In some variations the device aist? includes

In operation, a device such as the owe shown in PIGS. maAings on either the central listener track or the strap 1008, 8A-$D may be fit to a subject b lacing the straps onto the or both.

hack and shoulders of the subject, attaching the belt eronnd 3-: PIG. 11 A shows another variation of an adjustable balance the waist of the subject, measuring and cutting the font evaluation system ta which the belt and the straps (e.g., shoulstraps, attaching the clips (ainnectors) to the ends of the der straps) are connected prior io being applied to the subject. straps, attaching the straps fo the bell, and then placing the In this variation, the back of the device fparticnlarly the weights as described above. region near the belt.) may inehtde one or more flexible or

In some variations the adjustable balance evaluation tool * non-flexible stays Jlftt ofany appropriate s:i¾- or length (e.g., includes just a belt, without the upper torso strops or vest the stays may be as long go ¾p the garment to the upper region. For exam le, an adjustable balance evaluation system thoracic area, or !onger) within or attached to the device to may include a belt as shown is FIGS. ¾A-88. pro vide increased jrepport to the device. The back strap region

FIGS. S and 98 tihistraie another variation of as adjustmay also be adjustable (not shown), and the front straps ma able balance evahiatkm system. The device shown in PIGS. ·« be adjustable as well, allowing the device to he custom-fit to 5>A and 9B is coofignred m adjustable "suspender" different body shapes and sitixs). For example, the frotti straps o tho tic. This vaci at ion may be at iache to a belt (e .g , the belt may he cut and t&c ends sitae bed to a eoenec tor (e . . , c.H p) for shown in FIGS. 8A-8B) around the patient's waist. The belt attachment to the front of the belt ,

may be matte of a susichabte material, and may include a FIG, 1 lii shows an aiwmetive variation, in which a comreceiving surface for ccoeiving β \¾cro-type hook on both i pression strap .1115 ( ^' which tnay be removable) may ^' be inside and/or outside of the belt, lite suspenders shown an anached to the back of the belt, providing additional support FIGS. 9A and SB are I ^' liily adjustabie in height in both Jiont to the wearer, Osmpj ssion strap 1115 may be elastic and and back for proper patient fit. A weight or weights may be niay be sewn to the side of the belt. The oiiivvajxi- laeiny side placed anywhere along the straps {or belt, in some variations). of the compression strap may also be configured lo allow For example, the weight may include a Yeiero or VHcro-type 5.1 connection of a weight (e.g., having a Velcro-iype receivi ng hook material (or be secured in a weight packet with a t¾s- surface). FIG, 1:1 B also inclKdes four ilexi e stays rbai ffiay wner such as Vefcro ook) and placed anywhere on the susbe se\vt): into the belt.

pender's straps. FIG. 12A shows another variation of an adjustable ^, balance la FIG.9 A, all or a portion of the straps may be ma e from evaluation systHjj, in which stiftemng or support members a Zloop or other Veiero-type receivable material, pririiciflariv 1201 are included ak» the ssraps iitntrin the device, and on he outside o f the device. The ends of the straps (region may also be present along the belt 1204. These support memmarked "l")ra ay include Velcro-hook type material to secure bers 1201 may be stifTemitg members, and may be ibraied of to the belt or other clip-on suspender hardware toay be used any appropriate asaferial, In some variations the sh!fen g to attach the straps to the belt. The region marked "2" may members are wire or other materia! secured to the strap(s) afeti he made of a Yelcro-type receivable material on both «j aod'or belt, hi some variations the stil&tttng material :nsa skies with ;> Velero-hook type materia! on the ends, allowing pro vide an ettachmeBt site for the weights or weight packets. adjustment of the length by folding this region back on itself FIG. 12B ilhistrates one variation in which the sfiifenirtg US 8,215,773 B2

23 24 member 1201 to» a back lor the weight » fee s*cur«d to a:; an outer shell thai covers the steps, belt and any weights.

(similar to t e embodiment sii wts in F!GS. 10A-10 ). hi The shell may include a liner, lite sbellxasy be secured to the some variations the weight, or weight packet, is threaded over straps and'or bell. FIG.17 illustrates a exampleof an adjust.* the track-like member on the garment. able balance evaluation system in whieli the system is eoti-

FIGS. 13A-25 illustrate various embodiments of garments s figured as a yoga shirt which may fit over or under the straps eoaii red as adj sta le balance evaluation systems or and beJttegKt&ofihe adjustable balance evaluation system to devices. I many of these variations the adjustable balance which the weights may be attached.

evaluation system is incorporated or integrated with a garIn some variations the adjustable balance evaluation sysment sucl} as a jacket, shirt, pant, skirt, or the like. The tems may be comlgiued for use in a hospital or healthcare adjustable balance evaluation system may be adapted r so (e.g.. chronic health care) setting. Por example, FIGS. 18A lofig-tcnn use by securing the eight in position more persad 18B illustrate is hospital-style shirt to which one or mere manently after it has been positioned, orh uiayretnainadjusi- weights may be attached. It! addition, the garment raay able. In SOBM variations the garment includes a she!! or other include one or more reg ons configured, to help a third party ponkxi that eoatieets (either ^' er anently r removably) to (e.g., njjrse, tccMciaa, tbenipist. caregiver) to hold the the adjustable balance evaluation system, itsclxjdmg adjustis wearer secstrdy. l or example, in Ϊ-Κϊ. the adjustable able balance evaluation svstems such a» those described balance evaluation system is s¾own to include a belt region above (e.g, FIG. 7 -7E). ^" adapted to allow a caregiver to more- easily grasp and support

Par example, PIG. J3A shows an adjustable balance evaluIhc subjectwe;sriF¾iiiedi.wice. Siaiil rIy _t PIG.20 is ;m adjustation system coaf Igared as a bra . i ne.liui.mg si sports br . ί a ii« s able baiance eva!»ation system including a ring that may he example, the adjustable balance evaluation system may 20 used to k:>ld ttnto the patient. The otsjonty of the rest of the iitchide a hsed elastic stretch material tbat has an interact! dei'ice ii 'indes an ottter surface ofVeJcxn-!ike nuiierial for

US 8,215,773 B2

26

ca e provider, Ai the initki evaluation, a person's vestikv lar or ocular system is stimulated b one or mote stimuli or devices described herein, in some instances, the subject ^' s

FIGS.28A.-29 illustrate adjustable balance evaluation sysvestibular or ocular system is stimulated by attaching one or tems to be wont on the subject's head. For example, F IG .28A - more repositioitable stimuli, such as weights, to a garment s ows it head cap device ( oaent) to which .snips o tacky being want by the subject, or to eyeglasses, such as those febric (in which, light, thin weights can be affixed) along one shown FIG. 32. If. when compared to the initifil evaluatioa or more surfaces cover the head either Oft the iaskfc or outside of the subject's vision, the subject's vision does not show of tiie garment. Utilizing the method for determiaiftg the

itaptrsvfc¾iei!t,theoitet»t' titoresfiti!ttii and/ ox devices applied improvement in center of gravity control described herein,

to the subject's vestibular system can be adjusted or added to. One fitay simply observe a subject ^' s head Over their shoulder

These steps of comparing and adjusting or adding to tlx- one position or head on trunk control to help deternime weighting.

or more stimuli or devices ate repeated until the subject ^' s Based on static and dynamic control weight may be placed

strategically irt » mm-pmde mined locationfs) within or vision shews improvement when compared to the initial upon the flexible cap, headband, or crown encircling all or evaluation. In some instances, the improvement in vision part of the skull. One variation includes a cap with indicators occurs while the subject is being siimnbied. In other (e.g. , markings). The device or garment coo id also be made to it!sfancos. the improvement in vision ctmoccur or persist after look like a ^' baseball cap, bonnet, aim hat. Iwtwiiha visor. FIG. (he sti uli or device is no longer stimulating the subject. 2SB is an exa ple of a weight that could be attached in or The devices and systems described herein may also be upon the skull cap shown in F 5. 28A by any means already 2 configured as an orthotic to be worn on a subject's leg or described above. FRX 29 illustrates one variation of a eraaia! configured as a prosthetic leg or limb. As with the above- remolding orthosis lor deformations! plag cephaly (DP). described devices, weights can be attached to the orthotic or Conditions that limit iittiiiiis" mobility, sttcit as isolated tortiprosthesis by 8 screw, ring, magnet, wire (e.g., sliding them collis, hypotonia, and cervical spine anomalies, aiealso asso- onto the device like an abacus), hook and loop fastener (e.g., catted with DP. in this variation, a weight may be applied via 2? V lcro) or the like. In some variations the weight may be niesns already discussed within or u n the device or garcrimped on to the orthotic or prosthesis, hi oilier variations, ment Device* or garments adapted for use on the subject"* the ortbotic orprosthesis may be formed to be weighted one head (such as those shown in I'lG. 29) may include one or or more positions (i .e., the orthotic or prosthesis includes the more surfaces for attachment of otic* or more weights. i¾r weight). Attaetoeat of weight may help to impart increased example, tiie outer surface 12M of the headgear may be a ^w weight at n certain spot on the- leg to chan e control ofraove- Veto-like attachmen staterial■ Specialized vemtt tated head- ment or center of gravity for tainor control. By promoting or wear, helmets, or the like (e.g., helmets that provide addiconveying balance, the ortbotic or prosthesis can impro e a tional protection around the ears and nape of the neck) may be

subject's ability to walk, stand, or run.

adapted tor use as adjustable balance evaluation systems and/

or noxt-adjustahie orthotics. Devices or garments adapted for PIGS, 34-38 show a garment, such as a ^" vest, with a relause on a subject" a head also include, or can consist essentia lly tively rigid buck support. The materials, use of w igh s, and of, a weighted barretteor a headband to which thin weights or the methods for providing the weights on or to the garment, all other stimuli described herein can be attached. as described above, can be used,

In general, the devices and systems described herein may FIG. 35 illustrates the inside of a garment that can. rovide help promote or convey balance, Thus, these devices may he additional back support. The garment can he adjustable to fit configured as sportswear (e.g., site yoga, gol ί ^' , etc.. outfits), or patterns of different sizes. The garment can be of unitary other variations, include those shown in FIGS. 30-32. For design or be nuwleofmultiplecomponenis. RG.35 illustrates example, FIG. 39 illustrates a bra det'eufj to be wm on a a garment made of multiple com one ts. Side components subject' s ami . This bracelet, brace or cuff may be used to hold 3502 and 3504 iilitss&ise coetjponents that attach to a back different amounts of weights thai can fee secured vi a a screw, 45 component 3506. Side coniponenls 35(t2 and 3504 can attach ring, magnet, wire (e.g., sliding them onto the device like an to back component 35W by book, ttnd ¾iop tttaterial (e.g., abacus), Vefcro, or the like, tnsome variations the wtright may Vhlcro). buttons, xippors, or oilier ways of connecting gfr- be crimped on to the device, Attachment of weight may help ment components as described hereitt. I.,ocaiiotis 35.12, 3522, to impart eternise weight at s certain spot on the ami to 35J4, and 3524 ilhtstrate where Veiero-type book maierial change control of movement/center of gravity control of the so can be located on side components 350 and 35414 to connect artt! ftw tremor control Thus, in mm variations the device side components 3592 and 3504 to back component 35045. may e secured to the body so that it doesn't dramatically Buttons, biitfoH holes, or zippers can also he used. Compochange the position of the weight relative to the body. For nents 3502, 35(14, and 3506 cart be roostSy or entirely co ered example, the bracelet may be held to the arm irt a particular with lMibrokea loop material thai is reeeptive to Velero-type orientation using an elastic material. 3.1 hook tijaterial for p!acemeni of one or moiv si imul us.

FIG.3 J illustrates a shoe orthotic to which strips of eight FIG. 36 iilRsirates i!¾e ontsitfeoftte garment of F 35. can be applied to the foot or ankle to shift control of the Back compoflent 36 *» (whi h is the outside of back compoperson's toot and guide it medially or laterally. Wei ht could nent 35(H> in FIG.35) can include nabroken loop taaterial on be introduced through flic inside of the heel or at the laces. the outside at locations 360$, 34>16. 3610, and 3618, so that

Similarly, FIG, 32 illustrates a pair of glasses to which side components 3502 and 354M (side components Jfi02 and small sliding weights may be placed along the frame of the 3604 ia F!G. 36 iilasirfiie the outside of side components glasses to provide a means to eiwnge the COG of the bead, ,1502 and 35114) can attacb to back contpoften! 3606 via ie and/or to improve vision or equilibrium. As suggested Vfcteo-iype book material at ktcnttons 3512,3522, 3514. and already, the weights can he asymmetrical about the head. 3524 As mentioned above, other metitods, including, but not

This disclosure also includes methods for improving a w limiied to, buttons and dippers, can also be used. Back comsubject's vision. In these methods, a subject's vision is iniponent 3606 can also include some Velero-type hook material tially evaluated. This evaluation could be done by a health at. for example, locations 3626 and 3622 that will connect to US 8,215,773 B2

27 28 th unbroken loop material on 3502 and 3504. Side compo- The rigid or relatively rigid back support can be used with nents 3602 and 3604 can be connected to each oilier via other types of garments, stielt as those shown above, e.g„ a zi e * 3412 and.3614. belt without an upper portion with arm openings.

efeiiag also again to PIG. 35, back cv r» i 350$ One or more stimulus can.be attached to the unbroken loop includes a relatively rigid insert that support's the wearer's material on the inside of the garment by Velero-type hook back. Pocket 3516 is designed to receive and hold the insert. material or any oilier method of attaching stimulus hereiti The insert ma be sown into pocket 3516. or pocket 351 f> can described. The stimulus can be of any type described herein. e designed so to the insert is removable, thereby allowing The ti mult ti> can also be placed on the outsi e « t.be ga nneut . different inserts of different shapes, dif)exe«t ntatoia!s, or The gaanent can, but need not, include a position reference systemfor marking the position of one or taore suraulus, such different weights tt» be inserted, The insert can have a variety

as that shown in U.S. Pat. No. 7.156,792, which is incorpoof shape* designed to support the back. For exam le, the

rated herein by reference for ail prtr whes,

insert may have shapes such, as those shown by insert.3726 io

Another aspect of this disclosure is directed to devices for FIG. 37 or insert 4Θ2 in FIG. 34. As indicated inthe figures, stinitjiating a subject ^' s vestibular system, Deviees for stimu- the insert can have a wider portion at the ^■ bottom and narrower fating a subject's vesnbulaf systera can include any of the at the top. The shape can be considered generally triangular, devices described herein, ii -!wdtng multiple devices in comorn/et trafiy pentagonal (like a bomeptatej, but with witnded bination.

corners. isxcE if desired, some contour to on* or more of the Also inchfded m this disclosure are methods feimprovtng sides. T e insert can be relatively rigid i.e., more rigid than a subject's vestibular system. In these .nwltods. a subject's die garment .materia!, but have sufficient flexibility to contour vt'stibtdar s stem is initially evaluated. Generally, this evaltt- to ⁽ he wearerVback. Hie insert cat) fee made of materials that atiott cats be done by a Iwalfbcnre provider. Nest, the subject's range in degree of ilext bifity from ikxibfc enough to contour vestibttlitr system is siini lttied by one or more stimuli or to a wearer's back to being a stiiT, relatively inflexible eits- devices described tecin. In some instances, the stibject's tomi-zed moid formed to fit an Mdivsktafs back. The insert vesfibniar system is stinHtiatecl by attaching one or more may be made of any material suitable for providing back reposiitonali!e stimnli to a garment, orthotic, or device being support, including, but mi limited to, itches, high density worn by die subject, Tfie gannenfi orthotic, tw device may be polyethylene iHDPB), low density polyethylene (LDPE), any of the {garments, orfeofics. or devices described it! this rwiycarbooates, thmno iastic polymers, foams, etc. disclosure. Then, the subject's vestibular system is cvalaated

Pocket 3516 as openings 3520 aad 351.8 on each side. again, if, whets eortspared to the initial evaluation of the vesThese opening)! are a ho shown m openings 3804 and 38βδ on tibular system, the subject ' s vestibttlar system does not show PIG, 38, FIG, illustrates another view of the iasicf o tlie ti»ptx!vei¾i.¾t, theofte or awr e stimnli and/or devices ap lied garment where side components 820 and Mil are conto ihe subject's Yestibuiarsysteni can be adjusted or added to. nected to back component 3824. Arm openings 3816 and These steps o f comparing and adjusting or adding to the one 3S1JS are for the wearer's arms. Belt 3802 is f e through oris or tnore stnmt!i or devices are repeated until the subject's of openings 3804 and 806 and then around the outside of the vesf .ibi.itar system shows tmerovisnenf when compared to the insert (shown in dashed Boss) contained in pocket 381 and initial evaluation, la some itistances, the improvement itt the out the other opening. PIG. 31 illustrates the belt in farther vestibular system, occurs wiiile tiie subject is being stlmu- detail. Belt 3702 iadndes back 371 ⁾ 4 ⁽ hat goes around the lated. in other tnteces, the itnptevenient in the vestibnfctr insert in the pocket. Back 3704 can be made of a vented, systert] can persist or oeear after the stimuli or device is no elastic material or a relatively inelastic material, and can be longer svimulaiiflK tiie subject.

made of the same material as the rest of the belt. Back 3704 In addition to atethods described abo e for improving a can be the same size as sides of belt 3706 ami 37 8 or can be subject ^' s vestibular system and vision, this disclosure also larger, as illustrated itt FIG.37. Sides of belt 3706 and 3708 includes similar methods for improving speech (tneiudiiig, ean be made of ^* art elastic or inelastic material and c have out not limited to, clarity, vocal ataxia, projection, and timunbroken loop material on theoutsfcJc. The belt may be placed ing), cognition (including but not limited to, time spent on a inside it garment and sides 37 K> and 3708 can be pulled (ask, attention span, reading, .spelling, at)dxnit)li), proprtocep- through slots 3806 and 3804 in the garment fioo, waiktag, aenfo , standing, trunk control, spinal

Ends 3730 and 3712 of beli.3702 include Veterodype ktok reflexes, coordinstitm of upper and lower trunk, upper material on the inside at for example, positions 3714 and extremity con tesl, tinge r tapping, handwriting, lower extrem3716. Sides 3706 and 3708 of the belt can be connected to a ity control, general cooK!ii¾!t.iot!, sea sickness, latency of fat pane! 3718 that contains insert 3720 by. for example, response from pen ttbat ion frotti the grouad up or t¾e trunk ihreadinji«E«!s of belt 37.1 and 3712 through loops 3722 and down, swallowing, and kyphosis. In some instances, the 3724 cm front panel 3818. Insert 3720 ean be sown into front iaiprovenieot occurs while the- subject is being siioiulaied. hi panel 3718 or front panel 3718 can bavea re-scalable pocket so other instances, the improver! sent occurs alter the stimuli or that insert 3720 can be removable. Insert 37Ϊ0.may be made device is ao longer stimulating the snbjeei.

of any material suitable for providing hack support, includAny of the devices, systems and niethods described herein ing, but not limited to. acayltcs. high density polyethylene may be used in tomans, and also in non-hnmans, particularly (IfDPE), low density polyethylene (LDPE), polycarbonates, tian-knsan vertebrates. For example, FIGS, 33A-33B ilias- thermoplastic polymers, foains, etc. Once esds of belt 3710 trate vartaiions of mi adjustable balance cvahiation system and 3712 are fed throtig loops 372.2 and 3724. Ve! ro-type that may be nsed for a dog. PKr. 33A shows a dog wearing hook material at locations 37.14 and 3716 can fee connected to strap 3301 and VfcJcro device 3303 to which case or more unbroken loop material est) the outside of sides 3706 and 3708 weights rnavbeailached. An alternative variation is sho nin of the belt. When t e belt is wrapped around a subject and the FIG. 33B. FIGS. 33C and 331) illustrate weight 330S and ends of belt 3710 and 3712 are fed through loops 3722 and weight packet 3307 that may be used with the variations 3724, the eo.a!)ectionofthe ¾Jcxo-fype book material at 3714 shown ia PIGS. 33A and 33B.

and 3716 to unbroken loop material on the outside of sides of Although illustrative variations of the presets! invention belt. 3706 and 3708 secures die belt ia place. have been described above, it will be eviden » one skilled in US 8,2 .5,773 B2

29 30 the art thai various changes «aod<Jfcaik ma? be ma e (i) comparing (he sub ect's vision in (c) to the subject's without (teparhngircsmtlft; invention. For iftsiitnce. variations vision i» (a); antl

of the present invention may include weighted devices on the (e) repeating }¾>·{¾ until the subject's vision shows lower extremities or any other area of the body, in addition, improvement after the comparison hi (d).

the present invention may include the use of she procedures s 7. The method of claim ft, wherein ft device is a garment. describee- herein, for therapy, repeating the procedures as 8, The method of ciaim 7, herein the garment is cap, often as necessary, as the amount or placement of the weights headband, barretfs, or bat.

may change over time, ft is tniended in (fee following claima 9. The method of claim 7 _f wherein the garment is configto cover ail such changes and modification, falling within the ured to fit the subject's torso.

true scope and spirt! of the awe-ntton. to J ft. ^' The method of claim 6, wherein t e device is a pair of

What is claimed is: e eglasses or t) eyeglass f i we.

1. An apparatus tor stimulating a patient's sensory system, 1.1. A method of improvin a subject's vestibular system, comprising; comprising;

a gawneat made- of a flexible and wearable material, and (a) evaluating the subject ^' s vestibular system:

configured to be w rn on the patient's torso atid comis (b) stimulating the subject 's vestibular system by attach* itg prising an inner and an outer surface, the garment one or more repositiotiahie stimuli to a device worn b capable of receiving oneor more stimuli over a plurality the subject;

of iiiimediateiy adjacent and continuous positions; (c) reevaluating the subject's vestibular system;

one or more reposiikatahfe stimuli capable of sensortfiijy id) comparing the subjaefs vestibular system in (e) to the stimalating the patient and coitfigored to attach to (be subject's vestibular system in (aj: and

garment; and (e) repealing (b)-(d) until the subject's vestibular system at least one removable insert in an insert pocket within the shows improvement, after the comparison in id). garment for supporting the patient's back, (he insert 12■ The method of claim 11.. wherein the device is a pair of comprising a shape to physically support the patient's eye lasses or an eyeglass frame,

backand being relatively rigid compared to lite garment 13. The method of claim 11, wherein the device is a garinsteria!, ment.

2. The apparatus f claim i, further comprising belt. 14. The method of claim 13. wherein the garment is con¬

3. The apparatus ofclauw 2, wherein the belt fcrtSier comfigured to be worn on the subject's torso.

prises nemos for coupling to a fats anel for accommodating 15. The method of claim .13, whereits the garment is a cap, a removable insert, head band, or hat.

4. Hie apparatus of claim 2, wherein the Wt wrap* aimed IS, The method o claim 11. wherein the device is an the insert in the gormm, wherein the bed is tBorovah!y orthotic c nfig red to fit the subject's torse, threaded through a pair of openings defined on either side of 17. The method of claim 11, wherein the device is a prosthe insert pocket. thesis.

5. Tise apparatus of claim .1, wherein the apparatus h com» IS- The method of claim 17, wherein the prosthesis is a prised of at least two skfe components and a back component prosthetic limb.

removably coupled together at a plurality of immediately 19. The method of claim 18, wherein the prosthetic ihab is adjacent and continuous positions. a prosthetic leg.

6. A method of improving a subject's vision, comprising: 20. The method of claim 11. wherein, the one or more (a) evaluating the subject's vision; i reposrtioxiable stimuli comprise one or more weights, ih) stimulating the su ject's ocular system by attaching wherein fhe one or more eights combine to eight between one or more repositionable stimuli to a device worn by about 0.2% to aboni 2% of die aifeject's body weight. the su ject;

(c J reevehtating the subject' s vision: