Table 2.
Inclusion/exclusion criteria.
Inclusion criteria |
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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 upper extremity function as indicated by a score ≥1 on the NIHSS motor arm score, AND motor impairment judged clinically appropriate as defined by one or both 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 movement is not required. OR |
b. Manual muscle test (MMT) score of ≥2 on shoulder flexion and either elbow flexion or 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 score 0 or 1 |
Exclusion criteria |
1. Inability to give informed consent |
2. Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, ALS, dementia requiring medication |
3. Rapidly improving 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 psychosis within 2 years |
10. Active or prior (within 2 years) substance abuse |
11. Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc) |
12. Received UE botulinum toxin within 6 months. (other meds do not exclude) |