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

NCT07507006 | Not Yet Recruiting FDA Device

• 1 other identifier: FLASHSOLE-PILOT-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  Day 1 (single-session, during each 1-minute walking trial)

Secondary Outcomes (3)

• Adverse Events and Device-Related Discomfort

  Throughout the 2-hour study session on Day 1

• Perceived Usability (System Usability Scale)

  Immediately following the final walking trial on Day 1

• Comfort and Satisfaction (QUEST 2.0)

  Immediately following the final walking trial on Day 1

Study Arms (1)

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.

Device: Flash-Sole midsole device

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.

Also known as: Wearable robotic midsole, assistive midsole

Flash-Sole Walking Evaluation

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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) .

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha - Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

Related Links

• UNO Biomechanics Research Building

Study Officials

• Ahad Behboo

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator, PhD

CONTACT

402-554-3228; smohammadi@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is not masked. Both the participant and study team are aware of the intervention being used (Flash-Sole device on or off). The nature of the device and walking protocol makes blinding impractical.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 2, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)