Telerehabilitation In The Home After Stroke

Korábbi kezelés

• Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
• Modified Rankin Scale score was >2 prior to the index stroke
• A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke
• Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit
• Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study
• Expectation that subject will not have a single domicile address during the 6 weeks of therapy that is within 1.5-hr drive of the central study site [this can be waived at the discretion of the site PI]

Más betegség

• A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
• A diagnosis (apart from the index stroke) that substantially affects paretic arm function
• Significant cognitive impairment, defined as Montreal Cognitive Assessment score <22 [a lower score is permitted if due to aphasia and allowed by the site PI]
• On isolation precautions, e.g., due to active COVID-19

Egyéb

• Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
• Deficits in communication that interfere with reasonable study participation
• Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis
• Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
• Life expectancy < 9 months
• Pregnant; women of child-bearing potential must have a negative pregnancy test
• Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
• Contraindication to MRI

• Age 18-85 years at the time of randomization
• The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 90-270 days prior to randomization
• The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (out of 57) at Baseline Visit 1
• Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
• Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
• Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)