Critical Periods After Stroke Study (CPASS)
Purpose
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke: - early (initiated within 30 days) - subacute/outpatient (initiated within 2-3 months) - chronic (initiated within 6-9 months) The control group will not receive the therapy intervention during the 1-year study. Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset. Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
Conditions
- Stroke
- Brain Infarction
- Brain Ischemia
- Cerebral Infarction
- Cerebrovascular Disorders
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days) - Age >21 years - Able to participate in first study-related treatment session within 30 days of stroke onset - Able to participate in all study-related activities, including one year follow up and blood draws - Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1 - Recovering moderate motor impairment at the shoulder and elbow or hand such as: - Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item of the Motor Assessment Scale - wrist and finger movement is not required or - Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension. or - Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension. - Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale - Follows 2 step commands - No upper extremity injury or conditions that limited use prior to the stroke - Pre-stroke independence: Modified Rankin Score 0 or 1
Exclusion Criteria
- Inability to give informed consent - Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS), dementia requiring medication - Rapidly improving motor function - Clinically significant fluctuations in mental status in the 72 hours prior to randomization - Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test - Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on Modified Rankin Scale - Dense sensory loss indicated by a score of 2 on NIHSS sensory item - Ataxia out of proportion to weakness in the affected arm as described by a score of ≥ 1 on the NIHSS limb ataxia item - Active or prior psychosis within 2 years - Active or prior (within 2 years) substance abuse - Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc) - Received upper extremity botulinum toxin within 6 months (other medications do not exclude)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acute/Early |
Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. |
|
|
Experimental Sub-acute/Outpatient |
Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. |
|
|
Experimental Chronic |
Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke |
|
|
Placebo Comparator Control |
Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study. |
|
More Details
- Status
- Unknown status
- Sponsor
- MedStar National Rehabilitation Network
Study Contact
Detailed Description
Please see the following reference: Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.