Medical Policy

This document addresses the use of external lower extremity sensory prosthetic devices (for example, Walkasins^®, RxFunction, Inc., Eden Prairie, MN), which have been proposed to provide directional tactile feedback to improve balance and gait in individuals with peripheral sensory neuropathy. These are not functional electrical stimulation (FES) or threshold electrical stimulation (TES) devices.

Note: For more information, please see the following related documents.

• CG-OR-PR-12 Lower Limb Prosthesis
• CG-OR-PR-13 Ankle-Foot and Knee-Ankle-Foot Orthoses
• CG-OR-PR-08 Microprocessor Controlled Lower Limb Prosthesis
• CG-OR-PR-09 Microprocessor Controlled Knee-Ankle-Foot Orthosis

Note: For a high-level overview of this document, please see “Summary for Members and Families” below

Investigational and Not Medically Necessary:

The use of external lower extremity sensory prosthetic devices is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains why external lower extremity sensory prosthetic devices are not clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

External lower extremity sensory prosthetic devices, such as Walkasins, are wearable devices designed for people with peripheral sensory neuropathy who have reduced feeling in their feet. These devices do not support the leg or stimulate muscles. Instead, they detect pressure and body movement and provide vibration signals to the skin above the area with sensory loss. The goal is to help improve balance and walking.

What the Studies Show

External lower extremity sensory prosthetic devices aim to replace some of the sensory information that is lost because of nerve damage in the feet and legs. The devices use sensors placed near the foot and ankle to monitor movement and pressure. It then sends vibration signals to the skin to provide information about balance and body position. Unlike braces or electrical stimulation devices, these devices do not move muscles or support joints.

Several studies found improvements in balance scores, walking speed, and some measures of fall risk in people who used Walkasins. One study reported benefits after a single treatment session, while others reported improvements over several weeks or months. A case report described improvements in 1 person over more than 2 years. However, most studies included small numbers of people, did not use comparison groups, and could not fully rule out placebo effects or other reasons for improvement. Many studies also involved researchers who had financial relationships with the manufacturer. Professional organizations, including the American Physical Therapy Association (APTA), American Diabetes Association (ADA), American Geriatrics Society (AGS), Peripheral Nerve Society (PNS), and American Academy of Neurology (AAN), do not currently recommend these devices. Better studies are needed to know if these devices improve health. Reported harms were limited, but there is not enough long-term information to allow conclusions about the possible benefits from using these types of devices. Better studies are needed to know if these devices improve health.

Is this clinically appropriate?

External lower extremity sensory prosthetic devices, such as Walkasins, are not clinically appropriate because they have not been proven to improve health.

(Return to Description/Scope)

Summary

External lower extremity sensory prosthetic devices are wearable medical devices designed to replace or augment lost sensory input from the feet and lower extremities in individuals with peripheral sensory deficits, most commonly due to peripheral neuropathy. Unlike braces or functional electrical stimulation (FES) devices, external lower extremity sensory prosthetic devices do not provide mechanical support or muscle stimulation. Instead, they detect information about foot pressure, balance, or body sway and deliver alternative sensory signals (usually tactile or vibratory feedback) to intact skin areas above the site of sensory loss. The evidence base is limited primarily to studies of the Walkasins external lower-limb sensory neuroprosthesis device and includes a small, randomized crossover trial, a prospective single-arm multicenter study, a case report, and exploratory neuroimaging research. These studies reported improvements in balance and gait measures, including Functional Gait Assessment (FGA) scores, gait speed, and reductions in fall rates over periods ranging from several weeks to 6 months. However, the evidence is limited by small sample sizes, lack of control groups in most studies, short follow-up in some investigations, and frequent manufacturer involvement. Specialty societies and professional organizations, including the American Physical Therapy Association (APTA), American Diabetes Association (ADA), American Geriatrics Society (AGS), Peripheral Nerve Society (PNS), and American Academy of Neurology (AAN), do not currently provide specific recommendations supporting the use of external lower extremity sensory prosthetic devices in clinical practice guidelines.

Discussion

Koehler-McNicholas (2019) evaluated the short-term effects of Walkasins in a randomized crossover study of 31 community-dwelling male Veterans (ages 56-84 years) with peripheral neuropathy, insensate feet, balance impairment, and elevated fall risk (baseline FGA < 23). Participants completed standardized balance training sessions with the device either turned ON or OFF, followed by crossover to the alternate condition. Use of Walkasins was associated with significantly greater improvements in gait and balance compared with the OFF condition. The mean improvement in FGA score was 4.4 ± 3.7 points with the device ON compared to 1.5 ± 3.2 points with the device OFF (p<0.01), exceeding the minimal clinically important difference (MCID) of 4 points. Overall, 17 of 31 participants (55%) improved by at least 4 FGA points during ON treatment compared with 7 of 31 (23%) during OFF treatment (p<0.001). Significant improvements were also observed in normal gait speed (0.97 to 1.06 m/s, p<0.005) and 4-Stage Balance Test performance (23.3 to 27.5 seconds, p<0.017) during ON treatment. Across both treatment sessions, mean FGA scores increased from 15.2 ± 4.8 to 21.1 ± 5.2 (p<0.001), and 16 of 31 participants improved beyond the FGA fall-risk threshold of 23, indicating a transition into the normal fall-risk range. Limitations include a small sample size (n=31) and consisted entirely of male Veterans, limiting generalizability to women and broader populations with peripheral neuropathy. The intervention and outcome assessments occurred during a single study visit, meaning only short-term effects were evaluated and no conclusions could be drawn regarding long-term fall reduction or durability of benefit. Neither participants nor the evaluating physical therapist were blinded to treatment assignment, creating potential performance and assessment bias. Peripheral neuropathy diagnoses were based on medical records and monofilament testing rather than comprehensive neurologic evaluations. Additionally, one study author was a co-inventor of the Walkasins technology, founder of RxFunction, and held financial interests in the company, although the authors stated that the funder had no role in data collection, analysis, or publication decisions.

Oddsson (2020) reported on the walk2Wellness Trial, a prospective, multicenter clinical trial that evaluated the effects of 10 weeks of home-based use of the Walkasins wearable sensory prosthesis in individuals with peripheral neuropathy, impaired plantar sensation, gait and balance dysfunction, and high fall risk. Of 52 enrolled participants, 45 (87%) completed the 10-week assessment period. Significant improvements were observed in several objective clinical outcomes. Mean FGA scores improved from 15.0 to 19.1 (p<0.0001), exceeding the MCID of 4 points and yielding a large effect size (Cohen’s d_rm=0.92). Normal gait speed increased from 0.86 to 0.95 m/s (p<0.0001) and fast gait speed from 1.24 to 1.33 m/s (p=0.002), while Timed Up and Go (TUG) improved from 13.8 to 12.5 seconds (p=0.012). Additionally, 13 participants improved beyond the FGA fall-risk threshold (> 22), moving into the normal fall-risk range. Among those who reported falls during the 6 months before enrollment (n=25), fall rates decreased from 13.8 to 7.4 falls per 1000 participant-days (p=0.014), and the number of fall-risk factors declined from 5.1 to 4.3 (p=0.023). However, the 4-Stage Balance Test did not improve significantly, and most participant-reported outcome measures remained largely unchanged. Limitations include a single-arm trial without a control group, sham intervention, or blinding, making it difficult to exclude placebo effects, regression to the mean, or other sources of bias. Participants could not be blinded because the device provides perceivable tactile stimulation, and the investigators acknowledged that creating an appropriate sham device would be challenging. The trial was funded by RxFunction, and several authors had financial relationships with the company, including employment, consulting, stock ownership, and inventorship of the technology. The sample size was small (n=45), and nearly half of participants were Veterans, resulting in a predominantly male cohort that may limit generalizability. The study duration was only 10 weeks, which limits conclusions regarding long-term effectiveness and fall prevention.

Wrisley (2021) reported a long-term case study of a 51-year-old man with type 2 diabetes and sensory peripheral neuropathy who used the Walkasins sensory prosthesis for 8-10 hours per day over more than 2 years while participating in a neurological wellness program. Prior to receiving the device, the individual had completed approximately 5 months of gait and balance training and had reached a plateau in functional improvement. Following Walkasins use, substantial improvements were observed across multiple balance and mobility measures. The Activities-specific Balance Confidence (ABC) Scale improved from 33% to 80%, the Vestibular Activities of Daily Living (VADL) score improved from 3.54 to 1.0, the FGA increased from 13/30 to 28/30, and the miniBESTest improved from 15/28 to 26/28. Gait speed increased dramatically from 0.23 m/s to 1.5 m/s, and TUG performance improved from 26 seconds to approximately 8-10 seconds over the course of follow-up. The individual reported decreased lower-extremity pain and cramping, increased community ambulation from less than 0.25 miles to more than 5 miles, and improved overall function. Notably, improvements exceeded published minimal detectable change thresholds for all major outcome measures and appeared to persist even when the device was temporarily turned off for 1 day after several months of use. Limitations include a single-participant case report, which precludes generalization to broader populations. The individual continued to participate in a neurological wellness program involving gait and balance training throughout the intervention period, making it impossible to isolate the independent contribution of Walkasins to the observed improvements. The participant was highly motivated, relatively young compared with many individuals with diabetic peripheral neuropathy, and had no recent history of falls, all of which may have influenced outcomes. The study lacked a control condition, blinding, or systematic withdrawal testing, making placebo effects, continued training effects, or natural variation difficult to exclude. In addition, many outcomes were collected repeatedly over time without a formal experimental design, and some assessments were performed with the device turned off only briefly, limiting conclusions regarding carryover effects. The authors also disclosed that Walkasins were supplied by RxFunction and that one author was a co-inventor, executive, shareholder, and board member of the company.

Hsu (2022) conducted an exploratory pilot neuroimaging study to investigate whether long-term use of the Walkasins sensory prosthesis was associated with changes in brain network connectivity in older adults with peripheral neuropathy and balance impairment. The study included 8 participants (mean age 73.7 years) enrolled from the larger walk2Wellness trial who underwent resting-state functional magnetic resonance imaging (MRI) and clinical assessments at baseline and after 26 weeks of daily Walkasins use. Participants demonstrated a mean improvement of 5.0 points on the FGA (from 14.7 ± 2.2 to 19.7 ± 1.5, p<0.001), exceeding the established MCID of 4 points. Gait speed improved by an average of 0.12 m/s (from 0.98 to 1.10 m/s), exceeding the MCID threshold, although this change did not reach statistical significance (p=0.13). TUG performance improved by 1.1 seconds (12.1 to 11.0 seconds; p=0.12). Neuroimaging analyses demonstrated that greater improvements in FGA scores were associated with increased within-network connectivity in the Default Mode Network (DMN), Somatosensory Network (SMN), and Frontoparietal Network (FPN) (all p<0.01), as well as increased connectivity between the DMN and FPN (p<0.01) and decreased connectivity between the SMN and both the cerebellum and FPN (p<0.01). The authors concluded that prolonged sensory replacement stimulation provided by Walkasins may induce neuroplastic changes in brain networks involved in gait and balance control. Limitations include that the study was an exploratory pilot investigation with only 8 participants, substantially limiting statistical power and increasing the risk of false associations. There was no control group, making it impossible to determine whether observed changes were attributable to Walkasins use, increased physical activity, natural variation, or other factors. The study examined only participants who volunteered for MRI imaging at a single site, introducing possible selection bias and limiting generalizability. Also, one author was a co-inventor, co-founder, shareholder, and board member of RxFunction, and data collection was supported by the manufacturer.

Oddsson (2022) published 26-week results from the walk2Wellness Trial. Of 69 enrolled participants, 44 completed 26-week follow-up assessments and 30 completed all in-person clinical testing. Improvements observed at the 10-week primary endpoint were largely sustained through 26 weeks. For the 30 participants with complete clinical assessments, FGA scores improved from 15.0 ± 3.9 to 19.2 ± 4.1 (p<0.00001), representing a large effect size (Cohen’s d_rm=1.38) and exceeding the MCID. Self-selected gait speed increased from 0.89 to 0.97 m/s (p=0.02; Cohen’s d_rm=0.49), while the 4-Stage Balance Test improved from 25.6 to 28.4 seconds (p<0.01; Cohen’s d_rm=0.47). Improvements in fast gait speed (1.30 to 1.37 m/s; p=0.07) and TUG (13.2 to 12.3 seconds; p=0.20) did not reach statistical significance. Among the 25 participants who reported falls in the 6 months before enrollment, fall rates decreased from 11.8 to 6.7 falls per 1000 participant-days, a 43% reduction (p=0.0043), and the number of fallers declined from 25 to 13 (p<0.0001). Across all participants, median fall rates decreased significantly (p=0.044). Participants reported high adherence, using the device on average 5.1 days per week. Limitations include a single-arm, unblinded trial without a control group, making it difficult to fully exclude placebo effects, regression to the mean, or other confounding factors. Fall outcomes were compared with retrospectively recalled pre-study falls, which are subject to recall bias and may underestimate actual baseline fall frequency. The COVID-19 pandemic disrupted follow-up assessments, resulting in only 30 of 44 participants completing the 26-week in-person outcome testing. Fall reduction was a post hoc analysis rather than a predefined primary endpoint, and the study was not specifically powered to evaluate falls and blinding was difficult because participants needed to perceive the tactile stimulation to use the device effectively. Several authors had financial relationships with RxFunction, including inventorship, employment, stock ownership, and leadership positions.

Kahya (2023) published a narrative review of wearable technologies that use noninvasive peripheral neuromodulation to improve mobility and gait function in older adults. The authors searched multiple databases through July 2021 and identified 41 technologies that met inclusion criteria. These technologies were categorized into sensory substitution (12 technologies), sensory augmentation (24 technologies; 17 closed-loop and 7 open-loop), and motor stimulation (5 technologies). Mechanical stimulation was the most common neuromodulation modality (28/41 technologies), followed by electrical (9/41), sound (3/41), and thermal (1/41) stimulation. The most frequently studied conditions were vestibular disorders, followed by peripheral neuropathy, Parkinson disease, multiple sclerosis, spinal cord injury, low vision/blindness, and general balance disorders. The review summarized evidence from individual studies showing improvements in gait speed, balance, postural control, fall risk, foot drop, navigation, and other mobility outcomes. Examples included the Walkasins® sensory prosthesis, which was reported in a referenced clinical study to improve balance, gait speed, and fall rates after 10 weeks of use. Limitations include that this was a narrative review, that did not perform a formal systematic assessment of study quality, risk of bias, or pooled quantitative analysis.  Additionally, available evidence is limited by small sample sizes, heterogeneous study populations, and substantial variability in study designs and outcome measures, making comparisons across technologies difficult. Many studies combined neuromodulation devices with rehabilitation or exercise programs, making it challenging to determine the independent contribution of the technology itself. Long-term retention and carryover effects remain uncertain, and there is limited evidence regarding the optimal duration or intensity of device use. Additional concerns include challenges with participant blinding, potential placebo effects, publication bias toward positive findings, and a lack of long-term safety and adverse-event data for many technologies. Furthermore, several authors had affiliations with RxFunction, the manufacturer of Walkasins.

External lower extremity sensory prosthetic devices (for example, Walkasins) claim to provide directional tactile feedback to improve balance and gait in individuals with peripheral sensory neuropathy. They are exempt from the premarket notification procedures by the U.S. Food and Drug Administration (FDA) as they are a non-invasive prosthetic device available by prescription for long-term daily use. To date, all published studies have involved investigators with affiliations or relationships with RxFunction, Inc., the manufacturer of Walkasins, which may introduce the potential for bias. The studies have been small, with no control groups or blinding, which can create potential performance and assessment bias. No major specialty associations or societies support use of these devices in their peripheral neuropathy guidelines. This includes the American Physical Therapy Association (APTA), American Diabetes Association (ADA), American Geriatrics Society (AGS), Peripheral Nerve Society (PNS), and American Academy of Neurology (AAN).

Peripheral Sensory Neuropathy: A condition characterized by damage or dysfunction of peripheral sensory nerves, resulting in impaired sensation, proprioception, and balance, most commonly affecting the feet and lower extremities. Symptoms may include numbness, tingling, pain, sensory loss, gait impairment, and increased fall risk.

Prosthetic Device: An artificial device or system designed to replace, restore, or supplement a lost or impaired anatomical structure or physiological function.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Associated Coding

When services are also Investigational and Not Medically Necessary for associated, secondary or subsequent procedures related to the device code listed above:

Peer Reviewed Publications:

1. Hsu CL, Manor B, Iloputaife I, et al. Six month lower-leg mechanical tactile sensory stimulation alters functional network connectivity associated with improved gait in older adults with peripheral neuropathy - a pilot study. Front Aging Neurosci. 2022; 14:1027242.
2. Kahya M, Hackman D, Jacobs L, et al. Wearable technologies using peripheral neuromodulation to enhance mobility and gait function in older adults-a narrative review. J Gerontol A Biol Sci Med Sci. 2023; 78(5):831-841.
3. Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE. Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - a randomized control cross-over study. PLoS One. 2019; 14(4):e0216212.
4. Oddsson LIE, Bisson T, Cohen HS, et al. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-the walk2Wellness trial. Front Aging Neurosci. 2022; 14:931048.
5. Oddsson LIE, Bisson T, Cohen HS, et al. The effects of a wearable sensory prosthesis on gait and balance function after 10 weeks of use in persons with peripheral neuropathy and high fall risk - the walk2Wellness Trial. Front Aging Neurosci. 2020; 12:592751.
6. Wrisley DM, McLean G, Hill JB, Oddsson LIE. Long-term use of a sensory prosthesis improves function in a patient with peripheral neuropathy: a case report. Front Neurol. 2021; 12:655963.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Academy of Neurologic Physical Therapy. Balance Rehabilitation for Peripheral Neuropathy. 2024. Available at: https://www.neuropt.org/docs/default-source/balance-and-falls-sig/balance-rehabilitation-for-peripheral-neuropathy_fact-sheet_clinician.pdf?sfvrsn=25c25843_1. Accessed on August 13, 2026.
2. Ther Peripheral Nerve Society. Guidelines for Management of Neuropathy. Available at: https://pnsociety.com/resources/guidelines/. Accessed on August 13, 2026.

1. RxFunction Inc. Our product Walkasins. Available at: https://rxfunction.com/our-product/. Accessed on August 13, 2026.

Peripheral sensory neuropathy
Walkasins

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