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StrokePhase 2TR-BR-1NCT07646522

Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil

A Phase 2 study testing Telerehabilitation in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this research study is to provide preliminary evidence of whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone in Brazil. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Telerehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
12 Jun 2026to 29 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years at the time of randomization.
  • The index stroke was radiologically verified, due to ischemia, and had time of onset 120±30 days prior to randomization.
  • The stroke caused upper extremity deficits as defined by Action Research.
  • Arm Test score 18-44 (out of 57) at Baseline Visit.
  • Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
  • Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit.
  • Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent).

Who cannot join

  • 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.
  • 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.
  • A diagnosis (apart from the index stroke) that substantially affects paretic arm function.
  • Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit.
  • Significant cognitive impairment, defined as Montreal Cognitive Assessment [a lower score can be permitted at the discretion of the PI].
  • Deficits in communication that interfere with reasonable study participation.
Show all 23Show fewer
  • Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis.
  • Modified Rankin Scale score >2 prior to the index stroke.
  • A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke.
  • Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye.
  • Life expectancy < 9 months
  • Pregnancy; women of child-bearing potential must have a negative pregnancy test.
  • Botulinum toxin to the paretic arm: received in the prior 3 months or expected by the 1-Month Visit.
  • 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.
  • Subject lacks sufficient Portuguese to comply with study procedures and TR instructions.
  • Contraindication to MRI.
  • Contraindication to TMS.
  • Box and Block Test score of ≥30 blocks with the unaffected arm within 60 seconds at Baseline Visit;
  • Spatial neglect interfering with reasonable participation in the study;
  • On isolation precautions, e.g., due to active COVID-19.
  • Expectation that participant will not have a single domicile address during the 6 weeks of therapy.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiza G. S. Edwards, PhD contact

+5516-36021202

trbr1@usp.br

Antonio Carlos Santos, MD, PhD contact

+551636022964

Brazil1 site, 1 recruiting

  • Ribeirão Preto Medical School, University of São Paulo

    Ribeirão Preto, São Paulo, 14049900

    Taiza G. S. Edwards, PhD, +5516-36021202, trbr1@usp.br

    Antonio Carlos dos Santos, MD, PhD

    Recruiting

Other trials in Brazil

About this study

Official title: Telerehabilitation and Biomarkers of Functional Recovery After Stroke in Brazil: TR-BR-1 Clinical Trial

The purpose of this research study is to provide preliminary evidence of whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone in Brazil. Evaluate the safety and feasibility of telerehabilitation in the Brazilian context. Explore the clinical, neuroimaging, neurophysiological, and economic factors that influence telerehabilitation efficacy in functional recovery following stroke.

Read the detailed description

This is a two-arm phase II randomized controlled trial with blinded outcome assessment. A total of 20 post-stroke participants will be randomized to either telerehabilitation added to usual care (TR+UC) or usual care alone (UC). The primary outcome measure is the Action Research Arm Test (ARAT), which assesses upper extremity motor function. Secondary measures will include feasibility and intervention-related outcomes.

Study participation will span approximately 4 months and includes 6 in-person assessment visits. At these visits, participants will complete a battery of assessments, including upper extremity motor function tests, resting-state functional electroencephalography (EEG), and a single magnetic resonance imaging (MRI) scan of the brain. Participants assigned to the TR+UC group will receive structured arm motor training consisting of 36 sessions of prescribed exercises, interactive games, and stroke education delivered over 6 weeks at a frequency of 6 days per week, with each session lasting approximately 70 minutes. TR+UC participants will continue all usual care concurrently. Participants in the UC group will continue all therapies recommended by their medical team without participating in telerehabilitation.

Conditions
Stroke
Being tested
Telerehabilitation, Usual Care
Keywords
stroke, telerehabilitation, functional recovery
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationDevice

    Participants 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.

  • Usual CareOther

    Usual care rehabilitation refers to the recommendations made by their care team.

Study groups in NCT07646522
Study groupRoleWhat they receive
Usual CareOtherParticipants in the usual care group will receive no TR, but will continue with the recommendations made by their care team.
Receives: Other: Usual Care
Telerehabilitation + Usual CareActive comparatorIn addition to the 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.
Receives: Device: Telerehabilitation; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.

    Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.

    Measured: From baseline to early (within 7 days) post-intervention

  2. Study feasibility in the Brazilian context - recruitment.

    Proportion of eligible participants who agree to take part in the study.

    Measured: Through recruitment completion - an average of 15 months

  3. Study feasibility in the Brazilian context - adherence.

    Proportion of participants who complete TR therapy with sessions of 40 minutes or longer.

    Measured: Through study completion (specifically end of therapy) - an average of 17 months

  4. Study feasibility in the Brazilian context - retention.

    Proportion of dropouts during the study participation period.

    Measured: Through study completion (specifically end of follow-up) - an average of 18 months

Secondary outcomes (2)

  1. Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.

    Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.

    Measured: From baseline to 1 month post-intervention

  2. Treatment-related adverse events reported by the participants.

    Number and severity of adverse events related to the telerehabilitation intervention reported by the participants.

    Measured: From the start of TR to early (within 7 days) post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start12 Jun 2026
  3. Primary completion15 Sep 2027 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized to TR + usual care (intervention) or usual care alone (control)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07646522
Sponsor's protocol ID
90571225.4.0000.5440
Other IDs
2025/10298-4, 2025
Acronym
TR-BR-1
Status last verified
Jun 2026
First submitted
24 May 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Non-PHI data will be shared with appropriate parties after the study is completed and published.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telerehabilitation in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taiza G. S. Edwards, PhD (+5516-36021202, trbr1@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. (time frame: From baseline to early (within 7 days) post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07646522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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