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Characterization and Clinical Trial of a Variable Friction Shoe

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Eligibility criteria shortened, about 7 wordsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Apr 3, 2024
    • Study description expanded, about 63 words
    v3
  4. Interventions: Variable Friction Shoe Training (Device) to Ankle Foot Orthosis (AFO) Training (Device), Variable Friction Shoe Training (Device)
    • Study description expanded, about 3 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Shirley Ryan AbilityLab
89 trials monitored
See 1 trial at risk
Stroke
3,531 trials monitored
See 153 trials at risk
More than one million Americans present with foot drop after stroke. As the aging population grows in the United States and across the world, incidence of stroke will grow as age is a key risk factor, thus there will be a need for low-cost, easy-to-use, and scalable solutions to administer proper therapy to promote recovery. This study will evaluate a Variable Friction shoe (VF shoe), a new low-cost medical device, for foot drop in an at-home setting.
Trial Details
NCT Number NCT06234124
Lead Sponsor Shirley Ryan AbilityLab
Collaborators: University of California, Santa Barbara, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Stroke
Related terms Stroke
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov