Flash-Sole Device for Motor Function
(Flash-Sole Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Ahad Behboo
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Walking Trials
Participants perform short walking tasks in standard shoes and Flash-Sole shoes, with the device active and inactive
Follow-up
Participants provide feedback on usability, comfort, and satisfaction with the Flash-Sole device
What Are the Treatments Tested in This Trial?
Interventions
- Flash-Sole
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will walk on a treadmill under two conditions: with the Flash-Sole device turned on (providing ankle assistance) and with the device turned off. This helps researchers compare walking performance and user experience between assisted and unassisted conditions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
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