Telerehabilitation In The Home After Stroke (TR-2)

June 8, 2026 updated by: Steven C. Cramer, MD, FAAN, FAHA, FASNR, University of California, Los Angeles

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 will undergo a variety of assessments including tests of arm function and a single MRI scan of the brain. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of assigned exercises, games, and stroke education; these total 70 minutes in length and occur 6 days a week for 6 weeks; TR subjects will also continue usual care. Patients in the usual care group only will not engage in TR but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Not yet recruiting
        • Rancho Los Amigos Research Institute
        • Contact:
        • Principal Investigator:
          • Charles Liu, MD
        • Sub-Investigator:
          • Shailesh Kantak, PhD
        • Sub-Investigator:
          • Susan Shaw, MD
      • Irvine, California, United States, 92868
        • Not yet recruiting
        • University of California, Irvine
        • Principal Investigator:
          • An Do, MD
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medical Center of USC
        • Contact:
        • Principal Investigator:
          • Sook-Lei Liew, PhD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Steven C Cramer, MD, FAAN, FAHA
        • Contact:
      • Pomona, California, United States, 91767
        • Recruiting
        • Casa Colina Hospital and Centers for Healthcare
        • Principal Investigator:
          • Emily Rosario, PhD
        • Contact:
      • San Diego, California, United States, 92103
        • Recruiting
        • Hillcrest Medical Center at UC San Diego Health
        • Principal Investigator:
          • Kunal Agrawal, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Health Research Institute
        • Contact:
        • Principal Investigator:
          • Matthew Edwardson, MD
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Not yet recruiting
        • Brooks Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Lauren Shapiro, MD
        • Sub-Investigator:
          • Mark Bowden, PT, PhD
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Sony Isaac, MD
        • Sub-Investigator:
          • Leslie Morse, DO
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Emory Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Michael Borich, PhD, PT
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Sandra Billinger, PhD, PT
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • David Lin, MD
        • Contact:
      • Charlestown, Massachusetts, United States, 02129
        • Not yet recruiting
        • Spaulding Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Qing Mei Wang, MD
      • Springfield, Massachusetts, United States, 01199
        • Not yet recruiting
        • Baystate Medical Center
        • Principal Investigator:
          • Gottfried Schlaug, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • Recruiting
        • University of Michigan University Hospital
        • Principal Investigator:
          • Chandramouli Krishnan, PhD
        • Contact:
        • Sub-Investigator:
          • Edward Claflin, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • David Putrino, PhD
        • Sub-Investigator:
          • Christopher Kellner, MD
        • Sub-Investigator:
          • Jenna Tosto, PT
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • NYP Columbia University Medical Center
        • Principal Investigator:
          • Joel Stein, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center
        • Contact:
        • Principal Investigator:
          • Jessica Cassidy, PhD, PT
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke University Hospital
        • Principal Investigator:
          • Wayne Feng, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Oluwole Awosika, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Christina Xia, MD
      • Cleveland, Ohio, United States, 44109
        • Not yet recruiting
        • MetroHealth Old Brooklyn Health Center
        • Contact:
        • Principal Investigator:
          • David Cunningham, PhD
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Recruiting
        • Jefferson Moss Rehabilitation Research Institute
        • Principal Investigator:
          • Dylan Edwards, PhD
        • Contact:
        • Sub-Investigator:
          • Alberto Esquenazi, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Parneet Grewal, MD
        • Sub-Investigator:
          • Michelle Woodbury, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The Institute for Rehabilitation and Research (TIRR) Memorial Hermann
        • Principal Investigator:
          • Gerard Francisco, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Houston/Memorial Hermann Hospital TMC
        • Principal Investigator:
          • Sean Savitz, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health
        • Principal Investigator:
          • Amit Sethi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Telerehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months
Time Frame: 2 months
The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
Moss Rehabilitation Research Institute

Investigators

  • Principal Investigator: Steven Cramer, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q221354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-PHI data will be shared with appropriate parties after the study is completed and published.

IPD Sharing Time Frame

Any time after September 30, 2030

IPD Sharing Access Criteria

Appropriate parties with appropriate intention for use of the data, starting 9/30/30, with access to PHI-free data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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