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

Inclusion Criteria7

Able to understand and provide informed consent for him or herself
Age 55 and older, male or female
Able to complete all functional outcome measures without the use of an assistive device
Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-chemotherapy, indicating that their PN has become a chronic condition.
Self-reported gait and balance problems
Foot size that allows the Walkasins to function appropriately
Willing to use the Walkasins device as recommended

Exclusion Criteria10

Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he/she is excluded because his/her balance is likely not impaired enough to benefit from Walkasins.)
Self-reported acute thrombophlebitis, including deep vein thrombosis
Self-reported severe peripheral vascular disease
Untreated lymphedema
Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
Self-reported, untreated fractures in the foot and ankle
Other neurological or musculoskeletal conditions that moderately or severely impact walking
Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
Weight of more than 300 pounds
Inability to perceive vibration from Walkasins Haptic Module

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).