RecruitingNot ApplicableNCT06682429

Telerehabilitation In The Home After Stroke

Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial


Sponsor

University of California, Los Angeles

Enrollment

202 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • Age 18-80 years at the time of randomization
  • The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
  • The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (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 Criteria18

  • 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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Interventions

DEVICETelerehabilitation

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.


Locations(27)

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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NCT06682429


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