NCT06959277 Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
| NCT ID | NCT06959277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RxFunction Inc. |
| Condition | Peripheral Neuropathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-06-17 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Lars Oddsson, PhD
STUDY DIRECTOR
RxFunction Inc.
Frequently Asked Questions
Who can join the NCT06959277 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Peripheral Neuropathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06959277 currently recruiting?
Yes, NCT06959277 is actively recruiting participants. Contact the research team at research@rxfunction.com for enrollment information.
Where is the NCT06959277 trial being conducted?
This trial is being conducted at Mesa, United States, Boston, United States, Saint Paul, United States, Amherst, United States and 2 additional locations.
Who is sponsoring the NCT06959277 clinical trial?
NCT06959277 is sponsored by RxFunction Inc.. The principal investigator is Lars Oddsson, PhD at RxFunction Inc.. The trial plans to enroll 200 participants.