Table 1.
CPASS inclusion and exclusion criteria
| Inclusion criteria |
| 1. Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 d of admission to inpatient rehabilitation |
| 2. Age ≥21 y |
| 3. Able to participate in first study-related treatment session within 30 d of stroke onset |
| 4. Able to participate in all study-related activities, including 1-y 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 two-step commands |
| 8. No UE injury or conditions that limited use prior to the stroke |
| 9. Prestroke 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 h 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 y) psychosis |
| 10. Active or prior (within 2 y) substance abuse |
| 11. Not expected to survive 1 y due to other illnesses (cardiac disease, malignancy, etc.) |
| 12. Received UE botulinum toxin within 6 mo (other medications do not exclude) |