Please select the eligibility criteria that correspond to the clinical trial below.
Title: Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial
Brief Summary: The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.


Options:
A: 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.
B: Inclusion Criteria:

* have had a stroke with a Rankin score of 2 or 3;
* was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital;
* understands instructions to allow participation in evaluations and interventions;
* has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96;
* has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises;
* live in an area serviced by high speed Internet.

Exclusion Criteria:

* severe body hemineglect;
* significant hemianopsia visual problems accompanied by hemineglect;
* uncontrolled medical problems;
* moderate to severe aphasia
C: Patient Inclusion Criteria:

* A final confirmed hospital diagnosis of acute stroke (ischemic or hemorrhagic).
* Patient living at home pre-stroke.
* Presence of stroke-related deficits at admission (defined as a National Institute of Health Stroke Severity score of \>=1).
* Presence of at least mild functional limitations at discharge (defined as a modified Rankin score \[mRS\] score of \>=1), or therapy ordered.
* Discharged directly home (includes patient's residence or that of a family member).
* Discharged to a rehabilitation facility (IRF or SNF) with the expectation of return to home within 4 weeks.

Patient Exclusion Criteria:

* Patients who live more than 50 miles from the hospital (for reasons related to the home visits).
* Patients discharged to nursing home, hospice care or LTCH (Long term care hospital).
* Patients who have clinically documented cognitive deficits or stroke-related impairments including aphasia sufficient to impact the consent process and for whom a proxy respondent is not available.
* Patients who fail the 6-item cognitive screening (SIS-6) for cognitive impairment (score \<=4) and for whom a proxy respondent is not available
* Patients enrolled in another acute stroke intervention trial that has a significant impact on the post-acute period (i.e., intensive data collection required of patient during follow-up).
* Limited life expectancy (\< 6 months) or significant medical comorbidity likely to impact completion of the study (e.g., severe mental illness, drug or alcohol use or dependence, metastatic cancer).
* Neither the patient nor caregiver speaks English.

Caregiver Inclusion Criteria:

* Age 18 or over.
* Are identified by the stroke patient as the primary caregiver (individual who has primary responsibility for assisting with the patient's care).
* Speaks English.
D: Inclusion Criteria:

* hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH or subarachnoid hemorrhage - SAH) in the past 3 months
* clinical depression symptoms (Geriatric Depression Score -GDS \>= 11

Exclusion Criteria:

* major psychiatric co-morbidity
* active suicidal ideation without ability to contract for safety
* current substance abuse
* physical inability to tolerate 1-2 hour sessions
* receptive or global aphasia
* reduced level of consciousness (GCS\<15).

Answer: A