Table 1.
Entry criteria.
| Inclusion criteria |
|---|
| 1. Age ≥18 years at the time of randomization |
| 2. Stroke that is radiologically verified, with any time of stroke onset prior to randomization |
| 3. Upper extremity motor Fugl Meyer (UE-FM) score of 28–66 out of 66; to insure some deficit is present, if UE-FM > 59, must also have Box & Blocks (B&B) score on affected side >25% lower than on non-affected side |
| 4. Box & Block Test score with affected arm is at least 3 blocks in 60 s at the first visit |
| 5. Informed consent and behavioral contract signed by the subject |
| Exclusion criteria |
| 1. A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia |
| 2. A diagnosis (apart from the index stroke) that substantially affects paretic arm function |
| 3. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures |
| 4. Severe depression, defined as Geriatric Depression Scale Score > 11 out of 15 |
| 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22; this can be waived at the discretion of the study PI, e.g., for aphasia |
| 6. Deficits in communication that interfere with reasonable study participation |
| 7. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye |
| 8. Life expectancy < 6 months |
| 9. Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk prior to completion of participation in this study |
| 10. Unable to successfully perform all 3 of the rehabilitation exercise test examples |
| 11. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy, or expectation that subject will be unable to participate in study visits |
| 12. Concurrent enrollment in another investigational study |
| 13. Subject does not speak sufficient English to comply with study procedures |
| 14. Expectation that subject will not have a single domicile address during the 12 weeks of therapy, within 75 miles of the central study site |