Telerehabilitation In The Home After Stroke
TR-2
1 other identifier
interventional
202
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2025
Longer than P75 for not_applicable stroke
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
August 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
April 14, 2026
August 1, 2025
3.8 years
November 7, 2024
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months
The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
2 months
Secondary Outcomes (1)
Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months
2 months
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study.
Telerehabilitation + Usual Care
EXPERIMENTALPatients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently.
Interventions
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
You may qualify if:
- 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)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Rancho Los Amigos Research Institute
Downey, California, 90242, United States
University of California, Irvine
Irvine, California, 92868, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767, United States
Hillcrest Medical Center at UC San Diego Health
San Diego, California, 92103, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216, United States
Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136, United States
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48108, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
NYP Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
MetroHealth Old Brooklyn Health Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Jefferson Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Institute for Rehabilitation and Research (TIRR) Memorial Hermann
Houston, Texas, 77030, United States
UT Houston/Memorial Hermann Hospital TMC
Houston, Texas, 77030, United States
University of Utah Health
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Cramer, MD
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 12, 2024
Study Start
August 22, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
April 14, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Any time after September 30, 2030
- Access Criteria
- Appropriate parties with appropriate intention for use of the data, starting 9/30/30, with access to PHI-free data.
Non-PHI data will be shared with appropriate parties after the study is completed and published.