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

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 17, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2027

Conditions
Peripheral NeuropathiesPeripheral Neuropathy Due to ChemotherapyPeripheral Neuropathy With Type 2 DiabetesBalance Control in ElderlyGait 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)."

Trial Locations (5)

14226

RECRUITING

Dent Neurologic Institute, Amherst

55102

RECRUITING

Fairview Frontiers, Saint Paul

77555

RECRUITING

University of Texas Medical Branch, Galveston

85206

NOT_YET_RECRUITING

OrthoArizona--Mesa Arbor Avenue, Mesa

02131

RECRUITING

Marcus Institute for Aging Research, Hebrew SeniorLife, Boston

All Listed Sponsors
lead

RxFunction Inc.

INDUSTRY