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New arm brace could help stroke survivors regain movement

NCT ID NCT04599036

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special arm brace that reads muscle signals can help stroke survivors with severe arm weakness recover better during early rehabilitation. Three veterans who had a stroke within the past 6 months will use the device alongside standard therapy. The goal is to see if this approach improves arm movement and daily function more than standard care alone.

What this could mean

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

Active substance
EMG controlled arm orthosis (device)
What this could lead to
If it works, this could point toward a new rehabilitation tool to help stroke survivors regain arm function and independence.
What could go wrong
This is a very small feasibility study with only 3 participants, so results may not apply broadly. The device requires specific muscle signals that not all patients can produce.

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

3 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Sep 2027

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 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Veterans over 18 years of age * 2 days to 6 months since the onset of ischemic stroke * Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device. * Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the Myopro software * MAS score 3 for the biceps, triceps, supinators and pronators of the impaired arm * Able to read and comprehend the English language * Able to follow directions * Medically and psychologically stable. Healthy Controls: Over 18 years of age No history of neurological or muscular problems that affect arm function Exclusion Criteria: Hemorrhagic stroke * Previous strokes affecting motor function on the opposite side. * Fugl-Meyer score of 2 on the following 3 items: 1\) finger mass extension, 2) grasp #1 test, and 3) shoulder flexion 90 - 180 degrees, elbow at 0 degree, and forearm neutral. * Shoulder subluxation, pain or dislocation * Shoulder passive range of motion \< 45 degrees in flexion and abduction * Fixed upper limb contractures on the impaired arm and hand * Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported. * Skin rash or open wound on impaired arm * Involuntary movements of the impaired arm * Pacemaker or other implanted devices * Metal in the skull * Claustrophobia, or inability to operate the MRI patient call button * Past history of seizures * Family history of medication refractory epilepsy * Chronic sleep deprivation, ongoing untreated sleep disorder * Pregnancy or pregnancy planning during the study period * Currently taking medications or substances that lower the threshold for onset of seizure. * Inability to understand English

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

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Other studies related to the condition(s) this trial covers.