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

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.

Conditions

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

Interventions

DEVICE

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.

OTHER

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).

Sponsors & Collaborators

• RxFunction Inc.

  lead INDUSTRY

Principal Investigators

• Lars Oddsson, PhD · RxFunction Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-17

Primary Completion

2027-06-30

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations