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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After providing informed consent, all participants will undergo a battery of instrumented mobility assessments (e.g., 6-minute walk test \[6MWT\], Functional Gait Assessment \[FGA\], etc.), questionnaires, and a 10-day habitual physical activity observation period, wearing an electronic event logger to derive the primary outcomes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Walkasins, a wearable device that sends sensory signals, helps people walk better and be more active. It is for adults age 60 or older with peripheral neuropathy (nerve damage), reduced feeling on the bottoms of their feet, and balance problems. Participants will wear Walkasins for 10 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 60 or older.
  • Have diagnosed peripheral neuropathy (nerve damage) with reduced feeling on the bottoms of your feet.
  • Have balance problems, shown by standing on one leg for less than 23 seconds.
  • Be able to walk on your own for at least 6 minutes without a cane, walker, or other walking aid. Rest breaks are allowed.
  • Be willing to use Walkasins as directed.
  • Be willing to take part in all activity tracking and study tests.

Who can't join

  • Be under 60, lack the required nerve damage and foot feeling loss, or not meet the balance test requirement.
  • Report a current inflamed vein with a blood clot, including a clot in a deep vein, or severe blood vessel disease in the arms or legs.
  • Have untreated lymphedema (swelling from fluid buildup).
  • Have an untreated sore, swelling, infection, inflamed skin, or rash on the lower leg near where the device is worn.
  • Report an untreated broken bone in the foot or ankle.
  • Have another nerve, muscle, bone, or joint condition that causes moderate or severe walking problems.
  • Use an ankle-foot brace for walking that keeps you from putting on Walkasins.
  • Weigh more than 300 pounds or be unable to feel vibrations from Walkasins.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

FL