RecruitingNot ApplicableNCT07554443

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

Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity

Sponsor

RxFunction Inc.

Enrollment

18 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

Balance Disorders Peripheral Neuropathy With Type 2 Diabetes Balance Physical Activities Peripheral Neuropathy Grade 2 or Greater Balance Impairment, Gait Disorders, Fatigue

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called External, lower limb sensory prosthesis for people with balance, balance disorders, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExternal, lower limb sensory prosthesis

Walkasins is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.