Tests Walkasins to help balance in people with nerve damage in the feet
Tests a foot device called Walkasins in adults with peripheral neuropathy and balance problems.
Plain-language title generated from the registry record
Registry title: Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Key facts
- Where
- Amherst, Boston, Galveston, Mesa, Pittsburgh, and Saint Paul, United StatesSee the 6 sites
Where in United States
- Dent Neurologic InstituteAmherst, United StatesTaking people
- Marcus Institute for Aging Research, Hebrew SeniorLifeBoston, United StatesNo longer taking part
- University of Texas Medical BranchGalveston, United StatesTaking people
- OrthoArizona--Mesa Arbor AvenueMesa, United StatesNo longer taking part
- University of PittsburghPittsburgh, United StatesTaking people
- Fairview FrontiersSaint Paul, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RxFunction Inc.
- Trial code
- NCT06959277
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Self-reported acute thrombophlebitis, including deep vein thrombosis; Self-reported severe peripheral vascular disease; Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use; Other neurological or musculoskeletal conditions that moderately or severely impact walking; 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.); Untreated lymphedema; Self-reported, untreated fractures in the foot and ankle; 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.