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

NCT06959277 | Recruiting FDA Device

• 1 other identifier: CIP 0010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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

Keywords

Walkasins; Peripheral Neuropathy; Balance Problems

Outcome Measures

Primary Outcomes (3)

• Functional Gait Assessment (FGA)

  The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability.

  Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52

• Patient-Specific Functional Scale (PSFS)

  The PSFS asks patients to define up to five specific tasks that they have difficulty with or are unable to perform because of their physical injury or disability. Some research studies adapt the PSFS by asking participants to list three tasks rather than five, which is the plan for this study. The patients then rate their difficulty in performing those tasks on a scale of 0 to 10 with 0 meaning "unable to perform activity" to 10 meaning "able to perform activity at the same level as before injury or problem." The ratings for the three activities are averaged. Higher scores indicate greater ability to perform the activity.

  Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52

• PROMIS® PROWalk

  Eight items that have the most relevance for measuring change in individuals who have received Walkasins were selected from the 165 items comprising the PROMIS Item Bank v2.0 - Physical Function. Specifically, the selected items measure an individual's ability to perform various activities that involve upright mobility (balance, standing, and walking). Participants rate the eight items on a scale of 1 to 5; the raw scores are converted to T-scores for comparison to national norms.

  Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52

Secondary Outcomes (10)

• 10-Meter Walk Test

  Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52

• Four-Stage Balance Test

  Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52

• Modified Multidirectional Reach Test

  Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52

• Single Leg Stance Test

  Baseline, Week 26

• Timed Up and Go (TUG) and Timed Up and Go Cognitive/Dual Task (TUG-COG)

  Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52

Other Outcomes (3)

• Falls Monitoring

  Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52

• Monofilament Test

  Baseline, Week 26, and Week 52

• Vibration Test

  Baseline, Week 26, and Week 52

Study Arms (2)

Walkasins User Group

EXPERIMENTAL

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.

Device: Walkasins; Other: Fall Prevention Training

Control Group

OTHER

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.

Other: Fall Prevention Training

Interventions

Walkasins DEVICE

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.

Walkasins User Group

Fall Prevention Training OTHER

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).

Control Group; Walkasins User Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RxFunction Inc.: lead

Study Sites (6)

OrthoArizona--Mesa Arbor Avenue

Mesa, Arizona, 85206, United States

ACTIVE NOT RECRUITING

Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

ACTIVE NOT RECRUITING

Fairview Frontiers

Saint Paul, Minnesota, 55102, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Related Publications (4)

• Hsu CL, Manor B, Iloputaife I, Oddsson LIE, Lipsitz L. Six month lower-leg mechanical tactile sensory stimulation alters functional network connectivity associated with improved gait in older adults with peripheral neuropathy - A pilot study. Front Aging Neurosci. 2022 Nov 3;14:1027242. doi: 10.3389/fnagi.2022.1027242. eCollection 2022.

  PMID: 36408098 BACKGROUND

• Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE. Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - A randomized control cross-over study. PLoS One. 2019 Apr 30;14(4):e0216212. doi: 10.1371/journal.pone.0216212. eCollection 2019.

  PMID: 31039180 BACKGROUND

• Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.

  PMID: 36204554 BACKGROUND

• Oddsson LIE, Bisson T, Cohen HS, Jacobs L, Khoshnoodi M, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial. Front Aging Neurosci. 2020 Nov 9;12:592751. doi: 10.3389/fnagi.2020.592751. eCollection 2020.

  PMID: 33240077 BACKGROUND

Related Links

• RxFunction is the manufacturer of Walkasins. The website provides additional information about the device.

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Mobility Limitation

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Oddsson, PhD

  RxFunction Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Research Project Manager

CONTACT

612-358-2141; research@rxfunction.com

Lars Oddsson, PhD

CONTACT

888-382-3518; research@rxfunction.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Control group participants will receive Walkasins after six months of taking part in the trial.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2025-10

Locations

US (6)