Clinical trial Recruiting at 1 site Interventional Ages 19 to 45

Flash-Sole: a wearable midsole that helps you push off while walking

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

Run by University of Nebraska · NCT07507006 · Data updated 2026-11-12

A small, single-session study will test if the Flash-Sole wearable midsole is safe, comfortable, and capable of aiding walking in healthy adults.

Quick facts

Study typeInterventional
Ages19 Years to 45 Years
SexAll
Enrollment10 (estimated)
SponsorUniversity of Nebraska
Academic / other
Locations1 site (Omaha, Nebraska)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedJanuary 1, 2028
Study endsJune 1, 2028
Registry record updatedOctober 16, 2026
Trial IDNCT07507006 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 19–45 who can walk independently and weigh under 80 kg, without recent injuries or conditions affecting gait.

Probably not a fit

Individuals with gait-affecting conditions, skin issues at the foot, implanted electronic devices, or any contraindication to wearing the device may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Feasibility study assesses a wearable robotic midsole called Flash-Sole, developed at the University of Nebraska at Omaha. In a lab setting, up to 15 healthy adults will try shoes with the Flash-Sole and compare walking with their usual shoes. The study measures safety, comfort, and whether the device activates and functions as intended, using gait analysis, EMG and sensor data, and user feedback. It uses a within-subject design with active and inactive device conditions during treadmill walking. No clinical outcomes are being tested, and there is no randomization or control group beyond baseline comparisons.

Why it matters

Potential benefit: If successful, the Flash-Sole could offer a wearable option to gently assist walking for individuals who need extra push-off.

How similar studies have gone: Previous early-stage wearables with soft actuators have shown feasibility in laboratory gait tasks, but this is an initial feasibility study for this specific device.

Who can join: the full rules

Show full inclusion / exclusion criteria
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) .

Where it's running

  • University of Nebraska at Omaha - Biomechanics Research Building
    Omaha, Nebraska, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.