Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 90-270 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
Rancho Los Amigos Research Institute
RECRUITING
Downey
University of California, Irvine
RECRUITING
Irvine
Keck Medical Center of USC
RECRUITING
Los Angeles
University of California, Los Angeles
RECRUITING
Los Angeles
Casa Colina Hospital and Centers for Healthcare
RECRUITING
Pomona
Hillcrest Medical Center at UC San Diego Health
RECRUITING
San Diego
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Brooks Rehabilitation Hospital
RECRUITING
Jacksonville
Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center
NOT_YET_RECRUITING
Miami
Georgia
Emory Rehabilitation Hospital
RECRUITING
Atlanta
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Spaulding Rehabilitation Hospital
RECRUITING
Charlestown
Baystate Medical Center
RECRUITING
Springfield
Michigan
University of Michigan University Hospital
RECRUITING
Ann Arbor
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Duke University Hospital
RECRUITING
Durham
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
NYP Columbia University Medical Center
RECRUITING
New York
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
MetroHealth Old Brooklyn Health Center
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Jefferson Moss Rehabilitation Research Institute
RECRUITING
Elkins Park
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
The Institute for Rehabilitation and Research (TIRR) Memorial Hermann
NOT_YET_RECRUITING
Houston
UT Houston/Memorial Hermann Hospital TMC
RECRUITING
Houston
Utah
University of Utah Health
RECRUITING
Salt Lake City
Contact Information
Primary
Steven Cramer, MD
tr2trial@mednet.ucla.edu
(424)522-7874
Time Frame
Start Date:2025-08-22
Estimated Completion Date:2030-06
Participants
Target number of participants:202
Treatments
No_intervention: Usual Care
Participants 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.
Experimental: Telerehabilitation + Usual Care
Patients 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.