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

2026년 6월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

중재적

등록 (추정된)

20

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Taiza G. S. Edwards, PhD
  • 전화번호: +5516-36021202
  • 이메일: trbr1@usp.br

연구 연락처 백업

  • 이름: Antonio Carlos Santos, MD, PhD
  • 전화번호: +551636022964

연구 장소

    • São Paulo
      • Ribeirão Preto, São Paulo, 브라질, 14049900
        • Ribeirão Preto Medical School, University of São Paulo
        • 연락하다:
          • Taiza G. S. Edwards, PhD
          • 전화번호: +5516-36021202
          • 이메일: trbr1@usp.br
        • 연락하다:
          • Antonio Carlos dos Santos, MD, PhD
        • 수석 연구원:
          • Taiza G. S. Edwards, PhD
        • 부수사관:
          • Antonio Carlos dos Santos, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
기간: 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.
기간: 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.
기간: 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.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.
기간: 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.
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
White matter integrity assessed using diffusion tensor imaging (DTI) magnetic resonance imaging (MRI).
기간: 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).
기간: 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).
기간: Baseline
nTMS motor mapping (predictive factor).
Baseline
Interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).
기간: 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.
기간: 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.
기간: 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).
기간: 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).
기간: 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.
기간: 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.
기간: From baseline to 1 month post-intervention
nTMS motor mapping (predictive factor).
From baseline to 1 month post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 12일

기본 완료 (추정된)

2027년 9월 15일

연구 완료 (추정된)

2028년 2월 29일

연구 등록 날짜

최초 제출

2026년 5월 24일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

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

IPD 공유 기간

Anytime after July, 2028.

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뇌졸중에 대한 임상 시험

Usual Care에 대한 임상 시험

구독하다