No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
50 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for individuals who have had a stroke and have trouble moving their arm. Participants will undergo a 6-week arm training program to help improve their movement.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a first-time stroke in the last 3 to 6 months.
I have difficulty moving my arm.
I score 44 or lower on the Upper Extremity Fugl-Meyer Assessment.
I can participate in a 6-week intensive upper extremity program in English.
You may not be able to join if
I have had a stroke on both sides of my body.
I have unstable medical conditions affecting my ability to function.
I had a serious injury to my arm before my stroke.
I have visual or hearing impairments that affect my participation.
I have significant difficulty with speech or cognition.
I cannot keep up with the study follow-ups.
I cannot undergo MRI scans.
I cannot undergo Transcranial Magnetic Stimulation (TMS).
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?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. This project seeks to generate fundamental knowledge about brain pathways that allow people t…
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. This project seeks to generate fundamental knowledge about brain pathways that allow people to move their arm after stroke and how these pathways change with rehabilitation; we expect this knowledge to translate to new therapies to reduce stroke-related disability.
We plan to enroll N = 50 patients with moderate to severe difficulty moving their arm after ischemic or hemorrhage stroke during the subacute period (3 to 6 months post stroke) into either 30 hours over 6 weeks of Arm Basis Training (a protocolized form of occupational therapy targeting motor control) or usual care. We will perform kinematic motor assessments, neuroimaging, and neurophysiology before and after therapy in order to test the hypothesis that intensive, target training improves arm motor control and induces corresponding anatomical and physiological changes of associated brain pathways.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* first time unilateral ischemic or hemorrhagic stroke occurring within the 3-6 months
* upper extremity motor impairment as measured by the Upper Extremity Fugl-Meyer Assessment (UE-FMA) Score \<= 44
* ability to participate in a 6-week intensive upper extremity intervention in…
Inclusion Criteria:
* first time unilateral ischemic or hemorrhagic stroke occurring within the 3-6 months
* upper extremity motor impairment as measured by the Upper Extremity Fugl-Meyer Assessment (UE-FMA) Score \<= 44
* ability to participate in a 6-week intensive upper extremity intervention in English as determined by a licensed occupational therapist.
Exclusion Criteria:
* bilateral stroke
* unstable medical status affecting functional status
* pre-stroke upper extremity injury or conditions that limited use
* visual or auditory impairment limiting ability to participate in study procedures
* significant aphasia (NIHSS sub-item 9 \> 1) or cognitive (NIHSS 1a or 1b or
1c \> 1) deficits
* known or expected inability to maintain follow-up through the study intervention and post- assessment
* contraindications to MRI
* contraindications to TMS
* known history of uncontrolled seizure disorder.
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