No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
202 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for people who have arm weakness from a stroke that happened 90 to 150 days ago. Participants will receive telerehabilitation to improve their arm function, alongside usual care, for 6 weeks.
Are You a Good Fit for This Trial?
Rules you outSignificant cognitive impairmentSevere depressionSevere UE spasticity
You may be able to join if
I am between 18 and 80 years old.
I had a stroke due to a blood clot or bleeding in the brain.
My stroke happened 90 to 150 days ago.
I have arm weakness that impacts my ability to move it.
I can follow simple commands for rehab exercises.
I agree to participate and sign a consent form.
You may not be able to join if
I have a serious other medical condition that affects my ability to participate.
I cannot or do not want to follow study procedures.
I have significant issues that affect my arm function apart from my stroke.
I have severe depression.
I have serious problems with memory or thinking.
I have trouble communicating that would affect my participation.
I have severe tightness in my arm muscles.
I do not have good enough vision in at least one eye.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)…
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.
Trial Locations
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Eligibility Criteria
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 Researc…
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
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