RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Nebraska • ClinicalTrials.gov ID: NCT07507006

Registry updated: 2026-10-16

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Description

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.

Interventions

Flash-Sole midsole device (Device)
The Flash-Sole is a wearable robotic midsole powered by dielectric elastomer actuators (DEAs). It is embedded in custom footwear and designed to provide ankle push-off assistance during walking. The device operates in two modes: powered (assistance on) and unpowered (assistance off), allowing researchers to assess its mechanical support and user comfort in both states.

Eligibility criteria

Inclusion Criteria: 1. Age: 19 to 45 years old at the time of consent 2. Able to understand study procedures and provide informed consent 3. Able to walk independently without assistive devices 4. Willing to wear the Flash-Sole device and complete gait trials during a single session 5. Body weight under 80 kg to comply with device safety specifications Exclusion Criteria: 1. Current or recent (within 6 months) lower-limb injury, surgery, or fracture 2. History of neurologic, musculoskeletal, or cardiovascular conditions affecting gait 3. Skin conditions, open wounds, or known allergies at the foot/ankle that interfere with device wear 4. Use of implanted electronic medical devices (e.g., pacemakers, neurostimulators) 5. Cognitive or language impairments that preclude informed consent or task participation 6. no medication related to musculoskeletal condition (e.g., pain relief medications or similar treatments) .

Conditions

Motor Function

Locations

University of Nebraska at Omaha - Biomechanics Research Building — Omaha, Nebraska, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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