Balance4Mobility: Walkasins for Peripheral Neuropathy and Balance Problems
This study, called Balance4Mobility, is looking at whether a device called Walkasins can help people with peripheral neuropathy (nerve damage that can cause weakness, numbness, and pain) improve their balance. Walkasins are external devices worn on the lower leg that aim to replace some of the nerve function needed for feeling foot pressure during standing and walking. The main goal is to see if using Walkasins daily for six months helps people become more aware of where their feet are placed. Researchers will compare people using Walkasins to a group not using them, by looking at how they perform on walking and balance tests. If you are 55 or older, have a diagnosis of peripheral neuropathy, and can walk without an assistive device, you might be able to join. The study's current status is unclear, and it plans to enroll 200 participants.
- Study design
- This is an interventional study with an unclear status, planning to enroll 200 participants. Researchers will compare people using Walkasins to a control group not using them.
- What's involved
- Participants will answer questions about their medical history and balance, and complete standing and walking tests at various times over 52 weeks. They will also watch an educational video and receive handouts on fall prevention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 52 weeks, with various assessments throughout this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Lars Oddsson, PhD · STUDY_DIRECTOR · RxFunction Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Functional Gait Assessment (FGA)Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability.
- Patient-Specific Functional Scale (PSFS)Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
The PSFS asks patients to define up to five specific tasks that they have difficulty with or are unable to perform because of their physical injury or disability. Some research studies adapt the PSFS by asking participants to list three tasks rather than five, which is the plan for this study. The patients then rate their difficulty in performing those tasks on a scale of 0 to 10 with 0 meaning "unable to perform activity" to 10 meaning "able to perform activity at the same level as before injury or problem." The ratings for the three activities are averaged. Higher scores indicate greater ability to perform the activity.
- PROMIS® PROWalkBaseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
Eight items that have the most relevance for measuring change in individuals who have received Walkasins were selected from the 165 items comprising the PROMIS Item Bank v2.0 - Physical Function. Specifically, the selected items measure an individual's ability to perform various activities that involve upright mobility (balance, standing, and walking). Participants rate the eight items on a scale of 1 to 5; the raw scores are converted to T-scores for comparison to national norms.