Recruiting

Flash-Sole

Sponsor:

University of Nebraska

Code:

NCT07507006

Conditions

Motor Function

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

Interventions

Flash-Sole midsole device

Study Details

Brief 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.

Conditions

Motor Function

Study ID

NCT07507006

Start date

Jul 1, 2025

Status verified date

Mar, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

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) .

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

Flash-Sole midsole 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.

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 and Locations

Central contacts

Research Coordinator, PhD

402-554-3228smohammadi@unomaha.edu

Locations

University of Nebraska at Omaha - Biomechanics Research Building

Recruiting

Omaha, Nebraska, United States, 68182

Contacts

Sahel Research Coordinator, PhD

402-554-3228smohammadi@unomaha.edu

Ahad Principal Investigator, PhD

402-554-7525abehboodi@unomaha.edu

More Information

Sponsor

University of Nebraska

Last update posted

Oct 16, 2026

Last verified

Mar, 2026

Keywords

  • Assistive Walking Device
  • Robotic Footwear
  • Gait Support
  • Wearable Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.