Washington, District of Columbia 20010


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.


Study summary:

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.


Criteria:

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. - 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)


NCT ID:

NCT02235974


Primary Contact:

Principal Investigator
Alexander W Dromerick, MD
MedStar National Rehabilitation Network

Margot G McCloskey, BA
Phone: 202-877-1071
Email: Margot.Giannetti@medstar.net


Backup Contact:

Email: Jessica.Barth@medstar.net
Jessica Barth, MS, OTR/L
Phone: 202-877-1031


Location Contact:

Washington, District of Columbia 20010
United States

Alexander W Dromerick, MD
Phone: 202-877-1946
Email: Alexander.W.Dromerick@medstar.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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