Can virtual therapy rebuild arm function after a stroke?
NCT ID NCT07646522
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether adding telerehabilitation (home-based, supervised and independent arm exercises) to usual care improves arm function and reduces disability after a stroke. Twenty adults in Brazil who had a stroke about 4 months ago will participate. The goal is to see if this approach is safe, feasible, and effective in the Brazilian context.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- telerehabilitation (device-based therapy sessions)
- What this could lead to
- If successful, this could provide an effective, home-based therapy option to improve arm movement and reduce disability after stroke.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply widely. The therapy requires significant time commitment and may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years at the time of randomization. 2. The index stroke was radiologically verified, due to ischemia, and had time of onset 120±30 days prior to randomization. 3. The stroke caused upper extremity deficits as defined by Action Research. 4. Arm Test score 18-44 (out of 57) at Baseline Visit. 5. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit. 6. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit. 7. 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. 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment \[a lower score can be permitted at the discretion of the PI\]. 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 \>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. Pregnancy; 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 1-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 Portuguese to comply with study procedures and TR instructions. 16. Contraindication to MRI. 17. Contraindication to TMS. 18. Box and Block Test score of ≥30 blocks with the unaffected arm within 60 seconds at Baseline Visit; 19. Spatial neglect interfering with reasonable participation in the study; 20. On isolation precautions, e.g., due to active COVID-19. 21. Expectation that participant will not have a single domicile address during the 6 weeks of therapy. 22. Distance from the participant's home to the study site greater than 120 km \[this can be waived at the discretion of the PI\]. 22\. Availability of a 2 m² space for a table and chair setup.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ribeirão Preto Medical School, University of São Paulo
RECRUITINGRibeirão Preto, São Paulo, 14049900, Brazil
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