No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 89
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for people with long-term arm weakness from a stroke. Participants will use a special device called MyoPro while receiving therapy for their arm recovery.
Are You a Good Fit for This Trial?
Rules you outPast history of seizuresPregnancy
You may be able to join if
I am between 18 and 89 years old.
I have arm weakness on one side due to a stroke that happened more than 6 months ago.
I can move my shoulder at least 30 degrees up and 20 degrees away from my body.
I can feel and control my arm muscles well enough to use the device.
I can understand and read English.
I am medically and psychologically stable.
I can put on and take off the MyoPro device by myself or with some help.
You may not be able to join if
I have had another stroke affecting my other arm.
I have severe shoulder pain or dislocation.
I cannot move my shoulder at least 45 degrees in any direction.
I have any fixed contractures in my impaired arm or hand.
I cannot support my arm’s weight and an additional 4 pounds without pain.
I have a skin rash or open wound on my impaired arm.
I have involuntary movements in my impaired arm.
I have a pacemaker or any metal implants that could interfere with testing.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning…
This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (\>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18-89 years of age
* Unilateral arm weakness due to stroke (6 months or more since onset)
* Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
* Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
*…
Inclusion Criteria:
* 18-89 years of age
* Unilateral arm weakness due to stroke (6 months or more since onset)
* Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
* Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
* 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 less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
* Able to read and comprehend the English language
* Able to follow directions
* Able to provide informed consent
* Medically and psychologically stable.
* Ability to don/doff MyoPro independently or have support as needed.
* Ability to undergo MRI
* Ability to undergo TMS procedures
Exclusion Criteria:
* Previous stroke(s) affecting motor function on the opposite side.
* Persistent and severe 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 non-healing wound on impaired arm
* Involuntary movements of the impaired arm
* Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
* Metal in the skull or deformity of the skull
* Claustrophobia, or inability to operate the MRI patient call button
* Contraindications for MRI (standardized screening form for MRI).
* Past history of seizures
* Family history of medication refractory epilepsy
* Pregnancy or pregnancy planning during the study period
* Currently taking medications or substances that lower the threshold for onset of seizure.
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