RECRUITING Not applicable ClinicalTrials.gov

Telerehabilitation In The Home After Stroke

Sponsor: University of California, Los Angeles • ClinicalTrials.gov ID: NCT06682429

Registry updated: 2026-10-09

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Description

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.

Interventions

Telerehabilitation (Device)
The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.

Eligibility criteria

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

Conditions

Stroke

Locations

Rancho Los Amigos Research Institute — Downey, California, United States
University of California, Irvine — Irvine, California, United States
Keck Medical Center of USC — Los Angeles, California, United States
University of California, Los Angeles — Los Angeles, California, United States
Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States
Hillcrest Medical Center at UC San Diego Health — San Diego, California, United States
Medstar Health Research Institute — Washington D.C., District of Columbia, United States
Brooks Rehabilitation Hospital — Jacksonville, Florida, United States
Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center — Miami, Florida, United States
Emory Rehabilitation Hospital — Atlanta, Georgia, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States
Baystate Medical Center — Springfield, Massachusetts, United States
University of Michigan University Hospital — Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
NYP Columbia University Medical Center — New York, New York, United States
University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
Duke University Hospital — Durham, North Carolina, United States
University of Cincinnati — Cincinnati, Ohio, United States
MetroHealth Old Brooklyn Health Center — Cleveland, Ohio, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Jefferson Moss Rehabilitation Research Institute — Elkins Park, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
The Institute for Rehabilitation and Research (TIRR) Memorial Hermann — Houston, Texas, United States
UT Houston/Memorial Hermann Hospital TMC — Houston, Texas, United States
University of Utah Health — Salt Lake City, Utah, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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