Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity
RxFunction Inc.
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.
Description
This will be a prospective within-participant study design conducted over a period of one year. 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. This initial (baseline) assessment, without the sensory assistance of the Walkasins, will allow participants to serve as their own control. Assessment and observation peri…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- DeviceExternal, lower limb sensory prosthesis
Walkasins is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.
Location
- Brooks Rehabilitation CenterJacksonville, Florida