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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Taiza G. S. Edwards, PhD
  • Telefonnummer: +5516-36021202
  • E-mail: trbr1@usp.br

Undersøgelse Kontakt Backup

  • Navn: Antonio Carlos Santos, MD, PhD
  • Telefonnummer: +551636022964

Studiesteder

    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14049900
        • Ribeirão Preto Medical School, University of São Paulo
        • Kontakt:
          • Taiza G. S. Edwards, PhD
          • Telefonnummer: +5516-36021202
          • E-mail: trbr1@usp.br
        • Kontakt:
          • Antonio Carlos dos Santos, MD, PhD
        • Ledende efterforsker:
          • Taiza G. S. Edwards, PhD
        • Underforsker:
          • Antonio Carlos dos Santos, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

12. juni 2026

Primær færdiggørelse (Anslået)

15. september 2027

Studieafslutning (Anslået)

29. februar 2028

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Anytime after July, 2028.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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