NCT07554443NARecruiting

Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity

RxFunction Inc.

Start Date

6/25/2026

Completion Date

12/1/2027

Summary

The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy. Participants will do the following as part of the study: * Complete a sensation and balance assessment to determine eligibility for the study. * Answer questions about their medical history, physical function, balance confidence, and sleep. * Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker. * Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed. * Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.

Detailed Description

This will be a prospective within-participant study design conducted over a period of one year. After providing informed consent, all participants will undergo a battery of instrumented mobility assessments (e.g., 6-minute walk test \[6MWT\], Functional Gait Assessment \[FGA\], etc.), questionnaires, and a 10-day habitual physical activity observation period, wearing an electronic event logger to derive the primary outcomes. This initial (baseline) assessment, without the sensory assistance of the Walkasins, will allow participants to serve as their own control. Assessment and observation periods will be repeated at the dispensing of the Walkasins device and after participants have acclimated to daily use, 10 weeks after participants have begun wearing the device.

Eligibility Criteria

Age Range: 60 years to No maximum

Inclusion Criteria: * Be 60 years of age or older * Have a diagnosis of PN with plantar sensory loss * Demonstrate balance impairment, defined as a Single-Leg Stance time of \<23 seconds * Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted) * Be willing to use the Walkasins device as recommended * Be willing to participate in all aspects of physical activity monitoring and study assessments Exclusion Criteria: * Under 60 years old * Do not have a diagnosis of PN with plantar sensory loss * Self-reported acute thrombophlebitis, including deep vein thrombosis * Self-reported severe peripheral vascular disease * Untreated lymphedema * Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use * Self-reported, untreated fractures in the foot and ankle * Other neurological or musculoskeletal conditions that moderately or severely impact walking * Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins * Weight of more than 300 pounds * Inability to perceive vibration from Walkasins Haptic Module * Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \<23 seconds

Interventions

DEVICE

External, lower limb sensory prosthesis

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Conditions

Peripheral Neuropathy With Type 2 DiabetesPeripheral Neuropathy Grade 2 or GreaterBalanceBalance Impairment, Gait Disorders, FatigueBalance DisordersPhysical Activities

Locations

Brooks Rehabilitation Center

Jacksonville, Florida 32216

United States