Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance (NCT07507006) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance
United States10 participantsStarted 2026-07-15
Plain-language summary
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.
Who can participate
Age range
19 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 19 to 45 years old at the time of consent
. Able to understand study procedures and provide informed consent
. Able to walk independently without assistive devices
. Willing to wear the Flash-Sole device and complete gait trials during a single session
. Body weight under 80 kg to comply with device safety specifications
Exclusion criteria
. Current or recent (within 6 months) lower-limb injury, surgery, or fracture
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful Activation of Flash-Sole Device Across Timing Conditions
Timeframe: Day 1 (single-session, during each 1-minute walking trial)