Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

Recruiting

Phase 1 Results N/A

Eligibility Criteria

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) at both the Screening Visit and Baseline 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 GDS 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 3 of the rehabilitation exercise test examples
13. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance 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 6 weeks of therapy, within 25 miles of the central study site and with Verizon wireless reception.**
- A site may enroll a person who does not meet exclusion criterion # 17 if this is specifically approved by the site's study PI.
- Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 ("MoCA score cannot be <22") can be waived.