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

Conditions

• Motor Function

Eligibility Criteria

Sex

ALL

Age

19 Years - 45 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Jul 15, 2026

Status verified

Mar 2026

Primary completion

Sep 15, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Flash-Sole Walking Evaluation
  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.

Primary Outcome Measure

Successful Activation of Flash-Sole Device Across Timing Conditions [ Time Frame: Day 1 (single-session, during each 1-minute walking trial) ]

Central Contacts

• Research Coordinator, PhD
  402-554-3228
  [email protected]

Locations (1)

Find similar trials in Omaha, NE

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