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Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Sponsor: RxFunction Inc.
Summary
The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground. Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study. During the study participants will be asked to do the following: * Answer questions about their medical history and balance. * Do some standing and walking tests. Some of the tests will be timed. * Attend study visits and participate in study phone calls. * Keep track of any falls and notify study staff if they fall. * Wear the Walkasins device on a regular basis.
Official title: Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals With Peripheral Neuropathy and Balance Problems - A Randomized Control Trial
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-06-17
Completion Date
2027-12-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Walkasins
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.
Fall Prevention Training
Participants will watch "6 Steps to Prevent a Fall," a short (2 minute) educational video from the National Council on Aging, which describes simple steps to reduce fall risk. To improve their access to the education provided, participants will also receive three handouts, produced by the Center for Disease Control and Prevention (CDC) STEADI initiative (Stopping Elderly Accidents, Deaths, and Injuries), to review after the study visit. The STEADI Initiative is a coordinated approach for healthcare providers to implement the American and British Geriatrics Societies' Clinical Practice Guideline for fall prevention (https://www.cdc.gov/steadi/index.html).
Locations (6)
OrthoArizona--Mesa Arbor Avenue
Mesa, Arizona, United States
Marcus Institute for Aging Research, Hebrew SeniorLife
Boston, Massachusetts, United States
Fairview Frontiers
Saint Paul, Minnesota, United States
Dent Neurologic Institute
Amherst, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States