NCT07554443Recruiting
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 25 Jun 2026
- Primary completion date
- May 2027
- Lead sponsor
- RxFunction Inc.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07554443
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 25 Jun 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Self-reported acute thrombophlebitis, including deep vein thrombosis
- Self-reported severe peripheral vascular disease
- Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
- Other neurological or musculoskeletal conditions that moderately or severely impact walking
Age
- Under 60 years old
Other
- Do not have a diagnosis of PN with plantar sensory loss
- Untreated lymphedema
- Self-reported, untreated fractures in the foot and ankle
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brooks Rehabilitation Center Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.