Substrates for Post-Stroke Arm Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Arm Basis Training
BehavioralThis program is a systematic training regimen specifically designed to improve proximal motor control for patients with severe upper extremity hemiparesis. The core principles of the Arm Basis Training Program focus on rebuilding the fundamental capacity for specific and selective motor control before progressing to more complex motor patterns.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arm Basis TrainingExperimental treatment 1 intervention
Group B: Usual Care Occupational TherapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Kinematic Measure of Upper Extremity Motor Control
Kinematic measures of Upper Extremity Motor Control include joint individuation index (a measure of how well joints can move independently of other joints) and shoulder-elbow coordination (a measure of how normal a point-to-point planar reaching movement is)
Time frame
Pre- and post- 6 weeks of therapy2
Change in Corticospinal Tract Axon Density on MRI
High-resolution diffusion MR neuroimaging will be performed, from which corticospinal tract axon density will be calculated
Time frame
Pre- and post- 6 weeks of therapy3
Change in Corticospinal Tract Neurophysiology
The primary neurophysiologic measure of interest will be MEP presence or absence at proximal upper extremity muscles. If MEP positive, secondary measures of corticospinal excitability will be the MEP recruitment curve slope as well as MEP amplitude (at 100% MSO).
Time frame
Pre- and post- six weeks of therapySponsors and contacts
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Massachusetts General Hospital
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov