Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity (NCT07554443) | Clinical Trial Compass
RecruitingNot Applicable
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
United States18 participantsStarted 2026-06-25
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Activity Score--Metabolic Equivalents (METs)
Timeframe: Over a period of ~12 weeks
2
Step Count
Timeframe: Over a period of ~12 weeks
3
Total Sedentary Time
Timeframe: Over a period of ~12 weeks
4
6-Minute Walk Test--Phase Coordination Index (PCI)