New arm brace could help stroke survivors regain movement
NCT ID NCT04599036
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
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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
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3 people
The number who actually took part.
- Started
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Oct 2020
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Robot could let stroke patients rehab their hands at home without a therapist
- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next