Telerehabilitation In The Home After Stroke
Sponsored by University of California, Los Angeles
About this study
The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone. Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
This is a randomized, assessor-blinded study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week 6-8 weeks. The hypothesis of this study is patients receiving TR in addition to their usual care will have significantly greater recovery of arm function compared to patients receiving usual care alone. Study participation will last approximately 8 months and includes 4 in-person visits. At these visits, patients wi…
Where this study is enrolling (27)
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Keck Medical Center of USC
Los Angeles, California
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Hillcrest Medical Center at UC San Diego Health
San Diego, California
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Casa Colina Hospital and Centers for Healthcare
Pomona, California
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University of California, Irvine
Irvine, California
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University of California, Los Angeles
Los Angeles, California
Show all 27 locations
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Rancho Los Amigos Research Institute
Downey, California
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Medstar Health Research Institute
Washington D.C., District of Columbia
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Brooks Rehabilitation Hospital
Jacksonville, Florida
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Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center
Miami, Florida
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Emory Rehabilitation Hospital
Atlanta, Georgia
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University of Kansas Medical Center
Kansas City, Kansas
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Baystate Medical Center
Springfield, Massachusetts
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Massachusetts General Hospital
Boston, Massachusetts
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Spaulding Rehabilitation Hospital
Charlestown, Massachusetts
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University of Michigan University Hospital
Ann Arbor, Michigan
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Icahn School of Medicine at Mount Sinai
New York, New York
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NYP Columbia University Medical Center
New York, New York
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University of North Carolina Medical Center
Chapel Hill, North Carolina
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Duke University Hospital
Durham, North Carolina
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MetroHealth Old Brooklyn Health Center
Cleveland, Ohio
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University of Cincinnati
Cincinnati, Ohio
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Cleveland Clinic Foundation
Cleveland, Ohio
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Jefferson Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania
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Medical University of South Carolina
Charleston, South Carolina
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UT Houston/Memorial Hermann Hospital TMC
Houston, Texas
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The Institute for Rehabilitation and Research (TIRR) Memorial Hermann
Houston, Texas
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University of Utah Health
Salt Lake City, Utah
Who can participate
Inclusion criteria
- ✓1. Age 18-80 years at the time of randomization
- ✓2. The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
- ✓3. The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (out of 57) at Baseline Visit 1
- ✓4. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
- ✓5. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
- ✓6. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)
Exclusion criteria
- ✕1. 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
- ✕2. 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
- ✕3. A diagnosis (apart from the index stroke) that substantially affects paretic arm function
- ✕4. Severe depression, defined as Geriatric Depression Scale Score \>10/15 at Baseline Visit 1
- ✕5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score \<22 \[a lower score is permitted if due to aphasia and allowed by the site PI\]
- ✕6. Deficits in communication that interfere with reasonable study participation
- ✕7. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis
- ✕8. Modified Rankin Scale score was \>2 prior to the index stroke
- ✕9. A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke
- ✕10. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- ✕11. Life expectancy \< 9 months
- ✕12. Pregnant; women of child-bearing potential must have a negative pregnancy test
- ✕13. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit
- ✕14. 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
- ✕15. Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
- ✕16. 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 \[this can be waived at the discretion of the site PI\]
- ✕17. Contraindication to MRI
- ✕18. On isolation precautions, e.g., due to active COVID-19
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.