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Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil (TR-BR-1)

9 de junho de 2026 atualizado por: Taiza G. S. Edwards, PhD, University of Sao Paulo

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Taiza G. S. Edwards, PhD
  • Número de telefone: +5516-36021202
  • E-mail: trbr1@usp.br

Estude backup de contato

  • Nome: Antonio Carlos Santos, MD, PhD
  • Número de telefone: +551636022964

Locais de estudo

    • São Paulo
      • Ribeirão Preto, São Paulo, Brasil, 14049900
        • Ribeirão Preto Medical School, University of São Paulo
        • Contato:
          • Taiza G. S. Edwards, PhD
          • Número de telefone: +5516-36021202
          • E-mail: trbr1@usp.br
        • Contato:
          • Antonio Carlos dos Santos, MD, PhD
        • Investigador principal:
          • Taiza G. S. Edwards, PhD
        • Subinvestigador:
          • Antonio Carlos dos Santos, MD, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Usual Care
Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team.
Usual care rehabilitation refers to the recommendations made by their care team.
Comparador Ativo: Telerehabilitation + Usual Care
In 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.
Usual care rehabilitation refers to the recommendations made by their care team.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
Prazo: From baseline to early (within 7 days) 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.
From baseline to early (within 7 days) post-intervention
Study feasibility in the Brazilian context - recruitment.
Prazo: Through recruitment completion - an average of 15 months
Proportion of eligible participants who agree to take part in the study.
Through recruitment completion - an average of 15 months
Study feasibility in the Brazilian context - adherence.
Prazo: Through study completion (specifically end of therapy) - an average of 17 months
Proportion of participants who complete TR therapy with sessions of 40 minutes or longer.
Through study completion (specifically end of therapy) - an average of 17 months
Study feasibility in the Brazilian context - retention.
Prazo: Through study completion (specifically end of follow-up) - an average of 18 months
Proportion of dropouts during the study participation period.
Through study completion (specifically end of follow-up) - an average of 18 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.
Prazo: 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.
From baseline to 1 month post-intervention
Treatment-related adverse events reported by the participants.
Prazo: From the start of TR to early (within 7 days) post-intervention
Number and severity of adverse events related to the telerehabilitation intervention reported by the participants.
From the start of TR to early (within 7 days) post-intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
White matter integrity assessed using diffusion tensor imaging (DTI) magnetic resonance imaging (MRI).
Prazo: Baseline
Cortical spinal tract integrity - lesion load (predictive factor).
Baseline
Interhemispheric connectivity of motor cortices assessed using resting-state functional magnetic resonance imaging (rs-fMRI).
Prazo: Baseline
rs-fMRI interhemispheric functional connectivity in the primary motor cortex (predictive factor).
Baseline
Motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS).
Prazo: Baseline
nTMS motor mapping (predictive factor).
Baseline
Interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).
Prazo: Baseline
rsEEG interhemispheric functional connectivity in the primary motor cortex (predictive factor).
Baseline
Change in upper-extremity Fugl-Meyer assessment (UE-FM) from baseline to the early post-intervention.
Prazo: From baseline to early (within 7 days) post-intervention
Change in UE-FM. UE-FM is a scale that measures upper limb motor function using a scale that runs from 0 to 66 points, with higher scores reflecting better upper extremity motor function.
From baseline to early (within 7 days) post-intervention
Change in Modified Rankin Scale (mRS) from Baseline to the early post-intervention.
Prazo: From baseline to early (within 7 days) post-intervention
Change in mRS. The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function.
From baseline to early (within 7 days) post-intervention
Change in interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).
Prazo: From baseline to early (within 7 days) post-intervention
Change in rsEEG interhemispheric functional connectivity in the primary motor cortex.
From baseline to early (within 7 days) post-intervention
Change in interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).
Prazo: From baseline to 1-month post-intervention
Change in rsEEG interhemispheric functional connectivity in the primary motor cortex.
From baseline to 1-month post-intervention
Change in motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS) from baseline to early post-intervention.
Prazo: From baseline to early (within 7 days) post-intervention
nTMS motor mapping (predictive factor).
From baseline to early (within 7 days) post-intervention
Change in motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS) from baseline to 1 month post-intervention.
Prazo: From baseline to 1 month post-intervention
nTMS motor mapping (predictive factor).
From baseline to 1 month post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

12 de junho de 2026

Conclusão Primária (Estimado)

15 de setembro de 2027

Conclusão do estudo (Estimado)

29 de fevereiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

24 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Non-PHI data will be shared with appropriate parties after the study is completed and published.

Prazo de Compartilhamento de IPD

Anytime after July, 2028.

Critérios de acesso de compartilhamento IPD

Appropriate parties with appropriate intention for use of the data, starting 07/01/2028, with access to PHI-free data.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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