Walkasins to improve balance for people with peripheral neuropathy
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
NA · RxFunction Inc. · NCT06959277
This project will test whether daily use of Walkasins helps people with peripheral neuropathy improve foot-placement awareness and balance over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | RxFunction Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Mesa, Arizona and 5 other locations) |
| Trial ID | NCT06959277 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled comparison of daily Walkasins use versus no device across multiple U.S. clinical sites over a six-month period. Eligible participants are adults 55 and older with chronic peripheral neuropathy and self-reported balance or gait problems who can complete functional tests without an assistive device. Study procedures include baseline and periodic timed standing and walking tests, questionnaires about balance and falls, regular clinic visits and phone calls, and daily use of the Walkasins device for those assigned to it. Control-group participants are offered the device after six months, and outcomes include self-reported foot-placement awareness plus objective measures such as gait speed and functional balance tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 or older with a clinical diagnosis of chronic peripheral neuropathy (including chemo-induced PN at least one year post-chemotherapy), self-reported balance or gait problems, appropriate foot size for the device, and the ability to complete functional outcome measures without an assistive device.
Not a fit: People with near-normal balance (for example able to stand on one leg for 30 seconds), active acute vascular conditions like thrombophlebitis or DVT, incompatible foot size, or those who require assistive devices for testing are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Walkasins could improve balance and gait speed and reduce fall risk in people with peripheral neuropathy.
How similar studies have performed: Prior published work, including a randomized crossover in PLOS ONE and the multi-site walk2Wellness trial, reported clinically meaningful improvements in gait speed and functional balance and reductions in fall rates with Walkasins use.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mesa, Arizona and 5 other locations
- OrthoArizona--Mesa Arbor Avenue — Mesa, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Marcus Institute for Aging Research, Hebrew SeniorLife — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
- Fairview Frontiers — Saint Paul, Minnesota, United States (RECRUITING)
- Dent Neurologic Institute — Amherst, New York, United States (RECRUITING)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Texas Medical Branch — Galveston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Research Project Manager
- Email: research@rxfunction.com
- Phone: 612-358-2141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Neuropathies, Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy With Type 2 Diabetes, Balance Control in Elderly, Gait Disorders, Walkasins, Peripheral Neuropathy, Balance Problems