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

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.

NCT Number	NCT07554443
Lead Sponsor	RxFunction Inc. Collaborators: Brooks Rehabilitation
Conditions	Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater, Balance, Balance Impairment, Gait Disorders, Fatigue, Balance Disorders, Physical Activities
Enrollment	18 participants
Start Date	2026-06-25
Primary Completion	2027-05 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-25