Recruiting

Walkasins

Sponsor:

RxFunction Inc.

Code:

NCT06959277

Conditions

Peripheral Neuropathies

Peripheral Neuropathy Due to Chemotherapy

Peripheral Neuropathy With Type 2 Diabetes

Balance Control in Elderly

Gait Disorders

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Walkasins

Fall Prevention Training

Study Details

Brief 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

Study ID

NCT06959277

Start date

Jun 17, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Walkasins User Group

Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.

other: Control Group

Participants randomized to the control group will receive fall prevention information during the baseline visit. After six months, they will receive Walkasins for use during the final six months of the trial.

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).

Primary outcome measure

  • Functional Gait Assessment (FGA) [ Time Frame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52 ]
  • Patient-Specific Functional Scale (PSFS) [ Time Frame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52 ]
  • PROMIS® PROWalk [ Time Frame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52 ]

Central Contacts and Locations

Central contacts

Clinical Research Project Manager

612-358-2141research@rxfunction.com

Locations

Dent Neurologic Institute

Recruiting

Amherst, New York, United States, 14226

Contacts

Principal Investigator:

Lixin Zhang, MD, PhD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Gregory Brusola, PhD, DPT, PT

409-772-0309gabrusol@utmb.edu

Carole Tucker, PhD, PT

409-747-1635cartucke@utmb.edu

Principal Investigator:

Gregory Brusola, PhD, DPT, PT

More Information

Sponsor

RxFunction Inc.

Last update posted

Jul 14, 2026

Last verified

Oct, 2025

Keywords

  • Walkasins
  • Peripheral Neuropathy
  • Balance Problems

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RxFunction Inc. on 2026-07-14.