The present disclosure relates to medical rehabilitation devices. More specifically, the present disclosure describes a shoe extension or shoe enhancement that may be used for gait modification.
Neuromotor and musculoskeletal impairments generally lead to asymmetry in walking patterns, which may reduce the walking capabilities of a patient and may cause skeletal deformities. As a result, the ability to perform activities of daily living may reduce, the risk of fall may increase, and the overall quality of life may be impacted. See Perry, J., M. Garrett, J. K. Gronley, and S. J. Mulroy. 1995. “Classification of Walking Handicap in the Stroke Population.” Stroke 26 (6): 982-89, incorporated herein by reference in its entirety.
Strokes in adults and cerebral palsy in children are some of the medical conditions that may lead to asymmetry in gait patterns and motor impairment. In the United States, stroke is a leading cause of disability and death. As a result of the asymmetry in gait patterns, individuals suffering from neuromotor impairments may have an increased dependence on the healthy side of the body. For example, if neuromotor impairments affect the right leg of an individual, the dependence on left leg increases with time due to the asymmetry in gait patterns. Gait cycle parameters such as walking velocity, cadence, and step length may be affected with asymmetry in gait patterns, and the risk of fall may also increase. See De Quervain, I. A., S. R. Simon, S. Leurgans, W. S. Pease, and D. McAllister. 1996. “Gait Pattern in the Early Recovery Period after Stroke.” The Journal of Bone and Joint Surgery. American Volume 78 (10): 1506-14; and Callisaya, Michele L., Leigh Blizzard, Michael D. Schmidt, Kara L. Martin, Jennifer L. McGinley, Lauren M. Sanders, and Velandai K. Srikanth. 2011. “Gait, Gait Variability and the Risk of Multiple Incident Falls in Older People: A Population-Based Study.” Age and Ageing 40 (4): 481-87. https://doi.org/10.1093/ageing/afr055, each incorporated herein by reference in their entirety.
Different techniques have been implemented to improve walking in individuals affected with gait pattern asymmetry. A majority of the existing techniques are applied on the unhealthy limb. In a traditional rehabilitation approach, when task-oriented training is conducted, verbal instructions are provided to the patient to adjust their walking pattern/rhythm so that gait parameters, such as cadence and step length, are modified to perform a functional task exercise repeatedly. See Langhorne, Peter, Julie Bernhardt, and Gert Kwakkel. 2011. “Stroke Rehabilitation.” Lancet (London, England) 377 (9778): 1693-1702. https://doi.org/10.1016/S0140-6736(11)60325-5; and Richards, C. L., F. Malouin, S. Wood-Dauphinee, J. I. Williams, J. P. Bouchard, and D. Brunet. 1993. “Task-Specific Physical Therapy for Optimization of Gait Recovery in Acute Stroke Patients.” Archives of Physical Medicine and Rehabilitation 74 (6): 612-20, each incorporated herein by reference in their entirety.
In a different approach, an auditory feedback system, such as a metronome, is used to prompt the patient to walk while following a predefined tone. In another approach, split treadmills may be used to improve gait pattern and reduce asymmetry. Split treadmills utilize two separate belts that are operated with corresponding engines. Therefore, the belts of the split treadmill may be used to alter gait parameters of both limbs simultaneously. See Choi, Julia T., and Amy J. Bastian. 2007. “Adaptation Reveals Independent Control Networks for Human Walking.” Nature Neuroscience 10 (8): 1055-62. https://doi.org/10.1038/nn1930; Yokoyama, Hikaru, Koji Sato, Tetsuya Ogawa, Shin-Ichiro Yamamoto, Kimitaka Nakazawa, and Noritaka Kawashima. 2018. “Characteristics of the Gait Adaptation Process Due to Split-Belt Treadmill Walking under a Wide Range of Right-Left Speed Ratios in Humans.” PloS One 13 (4): e0194875. https://doi.org/10.1371/journal.pone.0194875; and Reisman, Darcy S., Hannah J. Block, and Amy J. Bastian. 2005. “Interlimb Coordination during Locomotion: What Can Be Adapted and Stored?” Journal of Neurophysiology 94 (4): 2403-15. https://doi.org/10.1152/jn.00089.2005, each incorporated herein by reference in their entirety.
In view of the drawbacks of the existing gait modification systems and methods, where only the unhealthy limb is targeted to improve gait patterns, the system and method of the present disclosure targets the healthy limb to improve gait patterns. More specifically, the present disclosure describes a wearable shoe extension or shoe enhancement that may be worn on the healthy limb to reduce asymmetry of the step length and reduce the time on the least affected/healthy limb. By utilizing the device of the present disclosure in training, a patient with gait pattern asymmetry is encouraged to adjust their walking pattern such that the unhealthy limb is strengthened through increased weight bearing. Different mechanisms may be implemented to adjust the difficulty level applied to the least affected/healthy limb.
The present disclosure describes a shoe extension that may be used for gait modification. The shoe extension is utilized with a shoe worn on a healthy limb of a patient with gait asymmetry. By wearing the shoe extension on the healthy limb, resistance is introduced to the healthy limb such that the overall speed of motion of the healthy limb may be reduced. Thus, the patient may be prompted to adjust a walking pattern by applying weight on the unhealthy limb. The weight applied on the unhealthy limb may vary with the resistance applied to the healthy limb through the shoe extension. In particular, with an increase in the resistance applied to the healthy limb, the weight applied on the unhealthy limb may also increase. The unhealthy limb may be strengthened by gradually increasing the weight applied on the unhealthy limb.
The shoe extension described in the present disclosure includes a vamp section, a base section, an attachment strap, and a restraining mechanism. The vamp section is terminally connected to a top surface of the base section. When the shoe extension is used on the healthy limb, a toe box of the shoe worn on the healthy limb is positioned into a receiving slot formed by the vamp section. Moreover, when the toe box is positioned into the receiving slot, the base section is positioned along an outsole of the shoe. The shoe extension described in the present disclosure is held against the shoe using the attachment strap which is preferably positioned over a collar of the shoe. By using the shoe extension on the healthy limb, a length of the footwear increases such that the length of the footwear worn on the healthy limb is greater than a length of the footwear worn on the unhealthy limb. As a result of the length difference, a speed of motion of the healthy limb may reduce. By delaying the motion of the healthy limb, additional weight may be applied on the unhealthy limb for strengthening purposes.
In addition to the vamp section, the restraining mechanism may also be used to restrict movement of the healthy limb. To do so, the restraining mechanism is preferably integrated to a bottom surface of the base section. In one aspect, the restraining mechanism may be a plurality of suction cups that is distributed along the bottom surface. A distribution pattern of the plurality of suction cups and a size of each of the plurality of suction cups may vary in order to adjust the resistance applied on the healthy limb. In another aspect, the restraining mechanism may be a pressure-sensitive adhesive layer that is coated on the bottom surface. A thickness of the pressure-sensitive adhesive layer and a distribution of the pressure-sensitive adhesive layer may also vary to adjust the resistance applied on the healthy limb.
A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
All illustrations of the drawings are for the purpose of describing selected embodiments of the present disclosure and are not intended to limit the scope of the present disclosure or accompanying claims.
The present disclosure describes a shoe extension that may be used for modifying gait patterns in patients with asymmetrical gait patterns. The shoe extension is used on a healthy limb of a patient, and may be used to improve the strength of an unhealthy limb. In particular, the shoe extension of the present disclosure reduces a speed of motion of the healthy limb or otherwise encumbers the healthy limb such that the unhealthy limb is strengthened by increased weight bearing. Furthermore, the shoe extension may reduce a probability of trip and fall, reduce secondary postural deviations, and improve body image and dual task cognitive skills.
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In some embodiments of the invention the device includes a haptic feedback mechanism, pressure sensor, power supply (battery) and controller. A micro vibrator (e.g., mini vibration motor) and associated power supply are embedded in the base section 1 of the device. A pressure switch initiates a multistage haptic feedback that is expressed by the haptic feedback mechanism and felt by the wearer. The feedback is preferably in the form of vibrations that can vary in intensity or frequency in multiple stages. A first stage is triggered by a first pressure sensor which triggers the micro vibrator through the controller for a predetermined time.
The purpose of the haptic feedback is to encourage or train the wearer to bear more weight on the unhealthy limb. Vibrations or other mechanical disturbance provided by the haptic feedback mechanism initiates a feeling of discomfort in the healthy limb. The vibrations may vary in intensity or frequency in stages. In a first stage a relatively low vibration and energy modes are triggered encountered. As a wearer places greater weight on the device, a second pressure sensor initiates a second stage of vibration frequency or vibration intensity. A plurality of sequentially increasing vibratory energy and/or frequency is utilized such that the wearer places less weight on the healthy limb in favor of the unhealthy limb. The device preferably includes a controller that is programed with instructions to initiate and halt vibrations from the micro vibrator. The microcontroller may further include instructions for a timing or duration of vibration. For example, for an individual having a regular gait, the haptic device may be switched on at a pressure sensor set to trigger when the wearer is places about 50% of a maximum pressure encountered in a regular stride on the device. The microcontroller may initiate the vibrations from the device for a period of about 0.05, 0.1, 0.5, 1 or 2 seconds. As second and further stages of pressure are encountered, the microcontroller changes, preferably increases, the intensity or frequency of the haptic feedback for time periods such as 0.05, 0.1, 0.5, 1.0, 1.5 or 2 seconds.
In another embodiment, the upper surface of the base section (sole) of the device includes one or more protuberances that are preferably located in at the first end 31 or second end 23 of the device. In particular, a protuberances preferably has a length of approximately 1-3 or 1.5-2.5 inches, a width of 0.25 to 1 inches or 0.5 inches, and a height of from 0.1 to 0.5 inches, preferably 0.2-0.3 inches. The purpose of the protuberances is to provide feedback to the wearer. The protuberance is preferably located proximal to a front toe position or a heel position where it functions as a discomfort reminder and encourages or trains the wearer to bear more weight on the unhealthy limb.
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In another embodiment the lower layer of the shoe on the healthy leg will have a thin sheet of a permanent magnet with a certain polarity (e.g., + or −) and the patient walks on a long plastic sheet that has isolated wires powered by 12 volt DC and an adjustable current source to provide a magnetic field with a polarity that is opposite to the polarity in the shoe to ensure that both magnets would attract to reduce the speed of the health leg while the patient walks on the plastic sheet.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “substantially”, “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), +/−15% of the stated value (or range of values), +/−20% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all subranges subsumed therein.
Disclosure of values and ranges of values for specific parameters (such as temperatures, molecular weights, weight percentages, etc.) are not exclusive of other values and ranges of values useful herein. It is envisioned that two or more specific exemplified values for a given parameter may define endpoints for a range of values that may be claimed for the parameter. For example, if Parameter X is exemplified herein to have value A and also exemplified to have value Z, it is envisioned that parameter X may have a range of values from about A to about Z. Similarly, it is envisioned that disclosure of two or more ranges of values for a parameter (whether such ranges are nested, overlapping or distinct) subsume all possible combination of ranges for the value that might be claimed using endpoints of the disclosed ranges. For example, if parameter X is exemplified herein to have values in the range of 1-10 it also describes subranges for Parameter X including 1-9, 1-8, 1-7, 2-9, 2-8, 2-7, 3-9, 3-8, 3-7, 2-8, 3-7, 4-6, or 7-10, 8-10 or 9-10 as mere examples. A range encompasses its endpoints as well as values inside of an endpoint, for example, the range 0-5 includes 0, >0, 1, 2, 3, 4, <5 and 5.
The description and specific examples, while indicating embodiments of the technology, are intended for purposes of illustration only and are not intended to limit the scope of the technology. Moreover, recitation of multiple embodiments having stated features is not intended to exclude other embodiments having additional features, or other embodiments incorporating different combinations of the stated features. Specific examples are provided for illustrative purposes of how to make and use the compositions and methods of this technology and, unless explicitly stated otherwise, are not intended to be a representation that given embodiments of this technology have, or have not, been made or tested.
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference, especially referenced is disclosure appearing in the same sentence, paragraph, page or section of the specification in which the incorporation by reference appears.
Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.