Critical Periods After Stroke Study (CPASS) "CPASS"


Phase N/A Results N/A

Eligibility 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
- 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.
- 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)