Status:
RECRUITING
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Lead Sponsor:
RxFunction Inc.
Conditions:
Peripheral Neuropathies
Peripheral Neuropathy Due to Chemotherapy
Eligibility:
All Genders
55+ years
Phase:
NA
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...
Detailed Description
A randomized cross-over study of short-term, in-clinic effects of Walkasins use, conducted at the Minneapolis Veterans Affairs Medical Center (VAMC) and published in PLOS ONE, found clinically meaning...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06959277
Start Date
June 17 2025
End Date
December 31 2027
Last Update
December 19 2025
Active Locations (6)
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1
OrthoArizona--Mesa Arbor Avenue
Mesa, Arizona, United States, 85206
2
Marcus Institute for Aging Research, Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
3
Fairview Frontiers
Saint Paul, Minnesota, United States, 55102
4
Dent Neurologic Institute
Amherst, New York, United States, 14226