Open
Actively Recruiting
Telerehabilitation In The Home After Stroke
About
Brief Summary
Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Maximum Age: 85
Inclusion Criteria:
- 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
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
- A diagnosis (apart from the index stroke) that substantially affects paretic arm function
- Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
- 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]
- 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
- 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
- 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
- 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
- Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
- 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]
- Contraindication to MRI
- On isolation precautions, e.g., due to active COVID-19
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Study Stats
Protocol No.
24-6224
Category
Brain/Neurological Diseases
Principal Investigator
Contact
- Ryan Mccarville
Location
- UCLA Westwood