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

Overview

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.

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.