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New powered brace aims to help stroke survivors walk better

NCT ID NCT04116671

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called the Neuromechanical Gait Assist (NMGA) that combines a powered knee brace with muscle stimulation to help people who have difficulty walking after a stroke. Five veterans with leg weakness and a stiff-legged gait will use the device in a lab while researchers fine-tune how it detects and assists their movements. The goal is to improve walking safety, speed, and energy use, but this is an early development study, not a proof of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neuromechanical Gait Assist (NMGA) device: a powered knee brace combined with surface muscle stimulation
What this could lead to
If successful, this could lead to a better walking aid that helps stroke survivors walk more safely and with less effort.
What could go wrong
This is a very small, early-stage study with only 5 participants, focused on device development rather than proving effectiveness. The device may not work for everyone or may need further refinement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Apr 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * More than 6 months post stroke. * Stiff-legged gait defined as a gait pattern manifesting as "dragging" or "catching" of the affected toes during swing phase of gait or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip. * Sufficient endurance and motor ability to ambulate at least 10ft continuously with standby assist. * Weakness at the hip, knee and ankle. * Poor lower extremity coordination due to weakness or tone. * Hip extension range to neutral. * Hip flexion range greater or equal to 90 degrees. * Passive range of ankle dorsiflexion to neutral with knee extended. * Sufficient upper extremity function to use a cane. Exclusion Criteria: * Severe knee extensor tone requiring \>25Nm of torque to flex the knee. * Ankle contractures of more than 0 degrees of plantar flexion and hip contractures of greater than 0 degrees of hip flexion. * Inability to grasp with both hands. * History of potentially fatal cardiac arrhythmias such as ventricular tachycardia, supra-ventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability. * Presence of a demand pacemaker. * Parkinson's Disease. * Edema of the affected limb. * Active pressure ulcers or wounds in lower extremities. * Sepsis or active infection. * Severe osteoporosis. * Uncontrolled seizures. * Presence of substance abuse. * Severely impaired cognition and communication. * Uncompensated hemineglect. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

hemiplegia Paresis stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemiparesis Stroke

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

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