Motor FunctionFLASHSOLENCT07507006
Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance
A study testing Flash-Sole midsole device in people with Motor Function, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Function
- What is being tested?
- Flash-Sole midsole device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Body weight under 80 kg to comply with device safety specifications
Who cannot join
- 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)
- Cognitive or language impairments that preclude informed consent or task participation
- no medication related to musculoskeletal condition (e.g., pain relief medications or similar treatments) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska at Omaha - Biomechanics Research Building
Omaha, Nebraska, 68182
Sahel Research Coordinator, PhD, 402-554-3228, smohammadi@unomaha.edu
Ahad Principal Investigator, PhD, 402-554-7525, abehboodi@unomaha.edu
About this study
Official title: Feasibility of Flash-Sole in Human Trials: An Active Midsole Powered by Stacked Dielectric Elastomer Actuators for Push-Off Assistance
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:
Read more
- 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.
Read the detailed description
This study evaluates the feasibility, usability, and functional performance of the Flash-Sole, a novel wearable robotic midsole developed at the University of Nebraska at Omaha (UNO). The Flash-Sole is powered by stacked dielectric elastomer actuators and designed to provide gentle push-off assistance during walking. This early-stage trial focuses on determining whether the Flash-Sole system can be safely and comfortably worn by healthy adults and whether it functions as intended in a laboratory environment.
The study uses a single-session, within-subject design with up to 15 participants. Each participant will complete walking trials in both baseline conditions (standard shoes) and experimental conditions (Flash-Sole shoes with the system either active or inactive). The research will compare gait parameters and user feedback across these conditions. No control group or randomization is used, as this study is exploratory and not powered to assess clinical outcomes.
During the single session (~2 hours), participants will:
- Complete screening for eligibility
- Perform short walking tasks in standard shoes and Flash-Sole shoes
- Walk on a treadmill at a self-selected comfortable speed
- Wear surface EMG and IMU sensors to measure muscle activity and movement
- Provide subjective feedback via standardized usability questionnaires (e.g., System Usability Scale and QUEST 2.0) The primary outcomes of interest include system functionality (e.g., successful actuator activation), usability (System Usability Scale score), and user-reported comfort and ease of use (QUEST 2.0). Secondary outcomes include basic gait characteristics (e.g., cadence, step length) and participant-reported adverse effects, if any.
All walking trials will be short (approximately one minute per trial), conducted with rest breaks between trials as needed. A fall-prevention safety harness will be worn at all times. No investigational drugs or implanted devices are used. The Flash-Sole system is investigational and not approved by the U.S. FDA. The study is not conducted under an IDE.
Data will be analyzed using descriptive statistics to characterize usability, comfort, and functional performance metrics. Due to the small sample size and feasibility nature of the study, inferential statistics will be limited and exploratory only.
This study is intended to inform future device refinements and guide the development of subsequent clinical trials involving individuals with walking impairments, such as stroke survivors or children with cerebral palsy.
- Conditions
- Motor Function
- Being tested
- Flash-Sole midsole device
- Keywords
- Assistive Walking Device, Robotic Footwear, Gait Support, Wearable Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash-Sole midsole deviceDevice
Also called Wearable robotic midsole, assistive midsole
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 group | Role | What they receive |
|---|---|---|
| Flash-Sole Walking Evaluation | Experimental | 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. Receives: Device: Flash-Sole midsole device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: Day 1 (single-session, during each 1-minute walking trial)
Secondary outcomes (3)
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
Measured: Throughout the 2-hour study session on Day 1
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)
Measured: Immediately following the final walking trial on Day 1
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)
Measured: Immediately following the final walking trial on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete the same walking trials with and without the Flash-Sole device in a single study session. There is no control or comparison group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahad Behboo, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507006
- Sponsor's protocol ID
- 0026-26-EP
- Acronym
- FLASHSOLE
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) collected in this study. This decision is due to the early-phase nature of the study and the limited sample size, which may increase the risk of re-identification despite de-identification efforts.