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NCT07507006 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Nebraska.

Not yet
Registry status
NA
Development phase
10
Enrollment target

NCT07507006: Clinical Trial NA study, sponsored by University of Nebraska.

NCT07507006 is a NA study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07507006, a NA study, has not yet begun recruiting, sponsored by University of Nebraska.

NOT YET RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target

Study 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.

Primary Outcome

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 (%)

Interventions

  • DEVICE Flash-Sole midsole device

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2026-07-15
Est. Completion 2026-09-30
Phase NA
University of Nebraska

407 total trials

What is known before NCT07507006 opens enrollment

NCT07507006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Flash-Sole midsole device is the first listed.

NCT07507006 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07507006 about?

NCT07507006 is a clinical study titled "Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking 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...

What is the current status of trial NCT07507006?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2026-07-15. Estimated completion is 2026-09-30.

What interventions are being tested in trial NCT07507006?

The interventions under investigation include: Flash-Sole midsole device (DEVICE).

Who is sponsoring clinical trial NCT07507006?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07507006's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07507006, the US trial registry maintained by the National Library of Medicine. NCT07507006 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.