Table 2.

Inclusion and exclusion criteria for patients enrolled in the study program.

Inclusion Criteria:

1.Age ≥18 years at the time of randomization

2.Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage,

and with time of stroke onset 4–36 weeks prior to randomization

3.Arm motor FM score of 22–56 (out of 66, higher is better) at the Screening Visit

4.Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the

Screening Visit

5.Informed consent signed by the subject

6.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 >10

5.Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22

6.Deficits in communication that interfere with reasonable study participation

7.A new symptomatic stroke has occurred since the index stroke that occurred 4–36 weeks prior to randomization

8.Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye

9.Life expectancy < 6 months

10.Pregnant

11.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 the 30 Day Follow-Up Visit

12.Unable to successfully perform all three of the rehabilitation exercise test examples

13.Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy

14.Concurrent enrollment in another investigational study

15.Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

16.Expectation that subject cannot participate in study visits

17.Expectation that subject will not have a single domicile address during the six weeks of therapy, within 25 miles of the central study site and with Verizon wireless reception.