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.
Age: 19 to 45 years old at the time of consent
Able to understand study procedures and provide informed consent
Able to walk independently without assistive devices
Willing to wear the Flash-Sole device and complete gait trials during a single session
Current or recent (within 6 months) lower-limb injury, surgery, or fracture
History of neurologic, musculoskeletal, or cardiovascular conditions affecting gait
Skin conditions, open wounds, or known allergies at the foot/ankle that interfere with device wear
Use of implanted electronic medical devices (e.g., pacemakers, neurostimulators)
Single group
Flash-Sole midsole device
DeviceThe 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.
Successful Activation of Flash-Sole Device Across Timing Conditions
This measure assesses whether the Flash-Sole device can reliably detect late-stance gait phases and trigger actuator activation without malfunction. Gait-phase detection and actuation success will be quantified as the percentage of walking trials with accurate and timely device triggering during treadmill walking. Unit of Measure: Percentage of successful trials (%)
Adverse Events and Device-Related Discomfort
Incidence of any device-related adverse events, including physical discomfort, perceived instability, tripping risk, or device malfunction. Events will be monitored throughout the session using observation and participant verbal reports. Unit of Measure: Number of events
Perceived Usability (System Usability Scale)
Participant-perceived usability of the Flash-Sole will be assessed using the System Usability Scale (SUS), a standardized 10-item instrument. Each item is scored on a 5-point Likert scale, producing a total score from 0 to 100. Higher scores reflect greater perceived usability. Unit of Measure: SUS Score (0-100; higher = better usability)
Comfort and Satisfaction (QUEST 2.0)
Participant-perceived comfort and satisfaction with the Flash-Sole device will be evaluated using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). Items are rated on a 5-point scale from 1 (not satisfied at all) to 5 (very satisfied), with higher scores indicating greater satisfaction. Unit of Measure: QUEST 2.0 score (1-5 per item; higher = more satisfied)
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This trial is not recruiting at the moment. You can still explore other options:
