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New treatment option for Chronic Stroke
Official title Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
ClinicalTrials.gov ID: NCT05296408
What this study is testing
- What it's testing
- 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.
- Time commitment: about 9 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.