Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance

Study acronym: FLASHSOLE
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Sep 15, 2026 → Jan 1, 2028
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Record History

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  1. Notable Primary completion pushed from Sep 15, 2026 to Jan 1, 2028 Show 7 more changesShow less
    • Recruitment opened
    • Study completion pushed from Sep 30, 2026 to Jun 1, 2028
    • Start date changed from estimate of Jul 15, 2026 to Jul 1, 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
    • Study description expanded, about 5 words
  2. Minor 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.
The goal of this clinical trial is to test a new shoe device called Flash-Sole. The Flash-Sole is designed to help support the ankle while walking. It was developed by researchers at the University of Nebraska at Omaha. The device uses soft materials and electrical signals to gently assist with foot movement. The main questions this study aims to answer are: * Is the Flash-Sole safe to wear? * Is it comfortable for users? * Does it work as intended to assist walking? This study will include up to 15 healthy adults between the ages of 19 and 45. The Flash-Sole is considered investigational and is not approved by the U.S. Food and Drug Administration (FDA). Participants will: * Complete one visit at the Biomechanics Research Building that lasts about 2 hours * Answer a few health questions to make sure they can join the study * Do short walking trials wearing their own shoes * Wear special shoes with the Flash-Sole device * Walk short distances on a treadmill at a comfortable speed while the device is turned on and off * Wear small, sticky sensors on their legs to measure movement and muscle activity * Wear a safety harness to prevent falls * Complete a short survey about how the shoes felt and how easy they were to use The purpose of this early study is to learn how the device performs and how people feel about wearing it. The results may help guide improvements to the device and inform future studies. This research is not testing whether the device helps people with walking problems yet, but it may lead to that kind of research in the future.
Trial Details
NCT Number NCT07507006
Lead Sponsor University of Nebraska
Conditions
(from sponsor)
Motor Function
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov