Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
Eligible age
60+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: RxFunction Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Jacksonville
Source: ClinicalTrials.gov · NCT07554443 · last updated 2026-06-25