- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07646522
Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil (TR-BR-1)
Telerehabilitation and Biomarkers of Functional Recovery After Stroke in Brazil: TR-BR-1 Clinical Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Taiza G. S. Edwards, PhD
- Numer telefonu: +5516-36021202
- E-mail: trbr1@usp.br
Kopia zapasowa kontaktu do badania
- Nazwa: Antonio Carlos Santos, MD, PhD
- Numer telefonu: +551636022964
Lokalizacje studiów
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazylia, 14049900
- Ribeirão Preto Medical School, University of São Paulo
-
Kontakt:
- Taiza G. S. Edwards, PhD
- Numer telefonu: +5516-36021202
- E-mail: trbr1@usp.br
-
Kontakt:
- Antonio Carlos dos Santos, MD, PhD
-
Główny śledczy:
- Taiza G. S. Edwards, PhD
-
Pod-śledczy:
- Antonio Carlos dos Santos, MD, PhD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 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.
|
|
Aktywny 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.
Ramy czasowe: 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.
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
White matter integrity assessed using diffusion tensor imaging (DTI) magnetic resonance imaging (MRI).
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: Baseline
|
nTMS motor mapping (predictive factor).
|
Baseline
|
|
Interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: From baseline to 1 month post-intervention
|
nTMS motor mapping (predictive factor).
|
From baseline to 1 month post-intervention
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Taiza G. S. Edwards, PhD, Ribeirão Preto Medical School, University of São Paulo
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia naczyniowo-mózgowe
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Choroby naczyniowe
- Choroby układu krążenia
- Uderzenie
- Administracja usług zdrowotnych
- Dostarczanie opieki zdrowotnej
- Lecznictwo
- Opieka nad pacjentem
- Usługi zdrowotne
- Zakłady opieki zdrowotnej i usługi
- Rehabilitacja
- Opieka postpenitencjarna
- Ciągłość opieki nad pacjentem
- Telemedycyna
- Zarządzanie opieką nad pacjentem
- Tereerehabilitacja
Inne numery identyfikacyjne badania
- 90571225.4.0000.5440
- 2025/10298-4 (Inny numer grantu/finansowania: São Paulo Research Foundation (FAPESP))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Uderzenie
-
IRCCS San Raffaele RomaMinistry of Health, ItalyRekrutacyjnyUderzenie | Sabacute StrokeWłochy
-
University of ZurichNieznany
Badania kliniczne na Usual Care
-
The University of Texas Health Science Center,...Tufts University; American Heart Association; Michael and Susan Dell FoundationRekrutacyjnyŻywienie w ciąży wysokiego ryzykaStany Zjednoczone
-
Evidence-Based Practice Institute, Seattle, WAZakończonyDepresja | Bezsenność | SamobójstwoStany Zjednoczone
-
Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... i inni współpracownicyAktywny, nie rekrutujący
-
Universitätsklinikum Hamburg-EppendorfWuerzburg University Hospital; University of Kassel; University DüsseldorfRekrutacyjnyZaawansowany nowotwór, różne, BNONiemcy
-
Johnson & Johnson Vision Care, Inc.ZakończonyOstrość wzroku, biomikroskopia w lampie szczelinowej (ocena barwienia rogówki)Stany Zjednoczone
-
University of AlbertaUniversity Hospital FoundationZakończonyMigotanie przedsionkówKanada
-
Yonsei UniversityJeszcze nie rekrutacjaMigotanie przedsionkówKorea Południowa
-
Chung Shan Medical UniversityZakończony
-
University of Kansas Medical CenterBioNexus KC; Blue KC (Blue Cross Blue Shield)ZakończonyZwiązane z ciążą | Opieka prenatalna | Dula Care | Zdrowie czarnej matki i niemowlątStany Zjednoczone
-
Weill Medical College of Cornell UniversityCornell UniversityWycofaneObciążenie opiekunaStany Zjednoczone