Recruiting

Telerehabilitation

Sponsor:

UCLA

Code:

NCT06682429

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Telerehabilitation

Study Details

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.

Conditions

Stroke

Study ID

NCT06682429

Start date

Aug 22, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92868

Contacts

Principal Investigator:

An Do, MD

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Sook-Lei Liew, PhD

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Steven C Cramer, MD, FAAN, FAHA

Casa Colina Hospital and Centers for Healthcare

Recruiting

Pomona, California, United States, 91767

Contacts

Principal Investigator:

Emily Rosario, PhD

Hillcrest Medical Center at UC San Diego Health

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Kunal Agrawal, MD

Medstar Health Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Matthew Edwardson, MD

Brooks Rehabilitation Hospital

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Principal Investigator:

Lauren Shapiro, MD

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Michael Borich, PhD, PT

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Sandra Billinger, PhD, PT

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

David Lin, MD

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Principal Investigator:

Gottfried Schlaug, MD

University of Michigan University Hospital

Recruiting

Ann Arbor, Michigan, United States, 48108

Contacts

Principal Investigator:

Chandramouli Krishnan, PhD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

David Putrino, PhD

NYP Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Joel Stein, MD

University of North Carolina Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Principal Investigator:

Jessica Cassidy, PhD, PT

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Oluwole Awosika, MD

Jefferson Moss Rehabilitation Research Institute

Recruiting

Elkins Park, Pennsylvania, United States, 19027

Contacts

Principal Investigator:

Dylan Edwards, PhD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Parneet Grewal, MD

UT Houston/Memorial Hermann Hospital TMC

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Sean Savitz, MD

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Amit Sethi, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 19, 2026

Last verified

Aug, 2025

Keywords

  • stroke
  • rehabilitation
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-19.