Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2027 → Dec 10, 2027
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Record History

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  1. Primary completion pushed from Jun 2027 to Dec 10, 2027 Show 6 more changesShow less
    • Study completion pushed from Dec 31, 2027 to Jun 2028
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised at 1 of 6 sites
    • Publications: details revised at 4 of 4 entries
    • Study description expanded, about 5 words
  2. Site details revised at 1 of 6 sitesv12
  3. Site contacts updated at 1 of 6 sitesv11
  4. Site details revised at 2 of 6 sitesv10
  5. Site details revised at 1 of 6 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 5 to 6v8
  2. Site details revised at 1 of 5 sitesv7
  3. Study sites: 4 to 5v6
  4. Site details revised at 1 of 4 sitesv5
  5. Site contacts updated at 1 of 4 sitesv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2025 to Jun 17, 2025
    • Site details revised at 4 of 4 sites
    v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RxFunction Inc.
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See 1 trial at risk
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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.
Trial Details
NCT Number NCT06959277
Lead Sponsor RxFunction Inc.
Conditions
(from sponsor)		 Peripheral Neuropathies, Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy With Type 2 Diabetes, Balance Control in Elderly, Gait Disorders
Related terms Mobility Limitation, Peripheral Nervous System Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov