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

Feasibility of Flash-Sole in Human Trials: An Active Midsole Powered by Stacked Dielectric Elastomer Actuators for Push-Off Assistance

Who can join

Ages 19 to 45 · All sexes · Healthy volunteers welcome

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) .

About the study

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.

What is being tested

• Flash-Sole midsole device (device)

Sponsor: University of Nebraska · Participants: 10 · Started: Jul 1, 2025

Contact the study team

• Research Coordinator, PhD · Phone: 402-554-3228

Official record on ClinicalTrials.gov — NCT07507006

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.