NCT06959277Recruiting
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 10 Dec 2027
- Lead sponsor
- RxFunction Inc.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06959277
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 17 Jun 2025 to the primary completion date, 10 Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dent Neurologic Institute Coordinator of this site? Confirm its status | Amherst | United States | Recruiting |
| Marcus Institute for Aging Research, Hebrew SeniorLife Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| University of Texas Medical Branch Coordinator of this site? Confirm its status | Galveston | United States | Recruiting |
| OrthoArizona--Mesa Arbor Avenue Coordinator of this site? Confirm its status | Mesa | United States | Active, not recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Fairview Frontiers Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.