RecruitingNot ApplicableNCT06959277

Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

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

Sponsor

RxFunction Inc.

Enrollment

200 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Neuropathy Due to Chemotherapy Peripheral Neuropathy With Type 2 Diabetes Peripheral Neuropathies Balance Control in Elderly Gait Disorders

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.

Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing wearable sensory devices called Walkasins — worn on the lower legs — that provide gentle vibration cues to help people with peripheral neuropathy (nerve damage that affects feeling in the feet and legs) improve their balance and reduce fall risk. **You may be eligible if...** - You are 55 years or older - You have been clinically diagnosed with peripheral neuropathy - You have noticeable balance problems - You can complete all balance and mobility tests without using a walking aid **You may NOT be eligible if...** - You need a cane, walker, or other assistive device to walk - You have other conditions affecting balance (such as severe vision loss or inner ear disorders) that are not related to peripheral neuropathy - You have had a recent fall-related injury or surgery that would prevent participation - You cannot provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWalkasins

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.

OTHERFall 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).