Home telerehabilitation program to improve arm function after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-85 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 90-270 days prior to randomization
3. The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (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 it's running

• Rancho Los Amigos Research Institute
  Downey, California, United States Recruiting
• University of California, Irvine
  Irvine, California, United States 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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• Dual-task balance training plus computer-based cognitive training after stroke

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  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.