Home telerehabilitation program to improve arm function after stroke
Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial
NA · University of California, Los Angeles · NCT06682429
This program will see if adding six weeks of daily home telerehabilitation for arm exercises to usual care helps people with arm weakness 90–150 days after stroke improve arm function and reduce overall disability.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 27 sites (Downey, California and 26 other locations) |
| Trial ID | NCT06682429 on ClinicalTrials.gov |
What this trial studies
This is a randomized, assessor-blinded study that assigns people with arm weakness after stroke to either home telerehabilitation plus usual care or to usual care alone, with the usual-care group offered telerehabilitation after the study. Telerehabilitation consists of 70 minutes per day of directed exercises, games, and stroke education, six days per week for about six weeks (36 sessions total). Study participation lasts about eight months and includes four in-person visits for clinical assessments and a single brain MRI, with blinded outcome testing of arm function and global disability. The primary goal is to compare recovery of arm function between the groups at scheduled follow-ups.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 with a radiologically confirmed ischemic or intracerebral hemorrhage stroke 90–150 days earlier who have persistent arm weakness (Action Research Arm Test 18–44 and ≥1 block on the Box & Block test) and can follow home-based exercises.
Not a fit: Patients who are outside the 90–150 day window, have very mild or very severe arm deficits outside the study range, have major active coexisting neurological/psychiatric/medical conditions, or are unable or unwilling to comply with home therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide an effective, scalable at-home therapy to speed arm recovery and lower disability after stroke.
How similar studies have performed: Prior telerehabilitation trials for post-stroke arm recovery have shown feasibility and some modest functional gains, but large randomized results showing clear superiority over usual care remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Downey, California and 26 other locations
- Rancho Los Amigos Research Institute — Downey, California, United States (NOT_YET_RECRUITING)
- University of California, Irvine — Irvine, California, United States (NOT_YET_RECRUITING)
- Keck Medical Center of USC — Los Angeles, California, United States (RECRUITING)
- University of California, Los Angeles — Los Angeles, California, United States (RECRUITING)
- Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States (RECRUITING)
- Hillcrest Medical Center at UC San Diego Health — San Diego, California, United States (RECRUITING)
- Medstar Health Research Institute — Washington D.C., District of Columbia, United States (NOT_YET_RECRUITING)
- Brooks Rehabilitation Hospital — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
- Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center — Miami, Florida, United States (NOT_YET_RECRUITING)
- Emory Rehabilitation Hospital — Atlanta, Georgia, United States (NOT_YET_RECRUITING)
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (NOT_YET_RECRUITING)
- Baystate Medical Center — Springfield, Massachusetts, United States (NOT_YET_RECRUITING)
- University of Michigan University Hospital — Ann Arbor, Michigan, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- NYP Columbia University Medical Center — New York, New York, United States (NOT_YET_RECRUITING)
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (RECRUITING)
- Duke University Hospital — Durham, North Carolina, United States (NOT_YET_RECRUITING)
- University of Cincinnati — Cincinnati, Ohio, United States (RECRUITING)
- MetroHealth Old Brooklyn Health Center — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- Jefferson Moss Rehabilitation Research Institute — Elkins Park, Pennsylvania, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
- The Institute for Rehabilitation and Research (TIRR) Memorial Hermann — Houston, Texas, United States (NOT_YET_RECRUITING)
- UT Houston/Memorial Hermann Hospital TMC — Houston, Texas, United States (RECRUITING)
- University of Utah Health — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Steven Cramer, MD — University of California, Los Angeles
- Study coordinator: Steven Cramer, MD
- Email: tr2trial@mednet.ucla.edu
- Phone: (424)522-7874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, stroke, rehabilitation, telehealth