Table 1.

CPASS trial inclusion and exclusion criteria.

Inclusion criteria
1. Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation 2. Age ≥21 years 3. Able to participate in first study-related treatment session within 30 days of stroke onset 4. Able to participate in all study-related activities, including 1 year follow up and blood draws 5. Persistent hemiparesis leading to impaired UE function as indicated by a score ≥1 on the NIHSS motor arm score, and motor impairment judged clinically appropriate as defined by one or more of the following:    a. Proximal UE voluntary activity indicated by a score of ≥3 on the upper arm item of the motor assessment scale; wrist and finger movements are not required    b. Manual muscle test (MMT) score ≥2 on shoulder flexion and either elbow flexion or extension or    c. 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 6. Score of ≤8 on the Short Blessed Memory Orientation and Concentration scale 7. Follows 2-step commands 8. No upper extremity injury or conditions that limited use prior to the stroke 9. Pre-stroke independence: Modified Rankin Scale score of 0 or 1
Exclusion criteria
1. Inability to give informed consent. 2. Prior stroke with persistent motor impairment or other disabling neurologic conditions such as multiple sclerosis, Parkinsonism, ALS, dementia requiring medication. 3. Rapidly evolving motor function. 4. Clinically significant fluctuations in mental status in the 72 hours prior to randomization. 5. Hemispatial neglect as determined by an asymmetry >3 errors on the Mesulam symbol cancellation test. 6. Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on modified Rankin scale. 7. Dense sensory loss indicated by a score of 2 on NIHSS sensory item. 8. Ataxia out of proportion to weakness in the affected arm as defined by a score ≥1 on the NIHSS limb ataxia item. 9. Active or prior (within 2 years) psychosis. 10. Active or prior (within 2 years) substance abuse. 11. Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc.). 21. Received UE botulinum toxin within 6 months (other meds do not exclude).