Walkasins to improve balance for people with peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Study contacts

• Study coordinator: Clinical Research Project Manager
• Email: research@rxfunction.com
• Phone: 612-358-2141

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.