Wczesna mobilizacja wspomagana dopplerem u dorosłych po ostrym udarze niedokrwiennym mózgu (DOP-MOBILIZE)
Wczesna mobilizacja z wykorzystaniem Dopplera u dorosłych po ostrym niedokrwiennym udarze mózgu - randomizowane badanie kliniczne
Post-stroke mobilization remains a subject of ongoing debate. While early mobilization-particularly the first out-of-bed mobilization-has been associated with reduced systemic complications and earlier rehabilitation, it also carries potential risks, such as neurological deterioration in the presence of hemodynamic instability.
In this study, the primary aim is to investigate whether early mobilization, guided by hemodynamic evaluation after acute ischemic stroke offers superior outcomes compared to standard clinical care.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Cerebrovascular diseases are the leading cause of death in Portugal and one of the most significant contributors to morbidity and disability.
Early mobilization after stroke is debated due to its potential benefits-such as fewer systemic complications and faster rehabilitation-and risks, particularly in patients with hemodynamic instability.
International guidelines support for early mobilization tailored to the patient's neurological status; however, the scientific evidence remains limited, resulting in heterogeneous practices across institutions.
Previous studies have highlighted the insufficient consideration of hemodynamic status when determining the timing of initial mobilization.
This study is a phase 3, pragmatic, prospective, multicenter randomized controlled trial with blinded outcome assessment (PROBE design: Prospective, Randomized, Open-label, Blinded Outcome Assessment), with an anticipated total duration of 36 months.
The study will be conducted in the Neurology Departments of the participating hospital centers and aims to: (1) evaluate the superiority of early mobilization guided by hemodynamic assessment following acute ischemic stroke, compared to standard clinical practice; (2) assess neurological deficits, quality of life, and cognitive function at three months, as well as hospital length of stay, blood pressure profile evolution, patient-reported outcome measures (PROMs), and employability; (3) compare adverse events between patients undergoing Doppler-guided early mobilization and those in the control group, including hospital-acquired infections, neurological deterioration, hemorrhagic transformation, and mortality.
Patients randomized to the intervention group will be mobilized according to carotid and transcranial Doppler ultrasound findings. In the presence of hemodynamic impairment, patients will undergo progressive mobilization, aiming to be out of bed by days 5 to 7 post-stroke, with gait training as neurologically feasible. In the absence of such findings, patients will begin mobilization immediately after the examination, with the goal of being out of bed and seated within 48 hours, including gait training when possible. Functional status at three months will be assessed using the modified Rankin Scale (mRS), which constitutes the study's primary endpoint.
All data collection procedures will follow formal and ethical research standards, ensuring that all informed participants voluntarily, anonymously, consent to take part in the study, with confidentiality maintained and no costs or harm to participants.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Joao Sargento Freitas, MD, PhD
- Numer telefonu: +351 239 400 400
- E-mail: joaosargentofreitas@ulscoimbra.min-saude.pt
Kopia zapasowa kontaktu do badania
- Nazwa: Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
- Numer telefonu: 8408 +351 239 400 400
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
Lokalizacje studiów
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Rijeka, Chorwacja
- Jeszcze nie rekrutacja
- University Hospital Rijeka
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Kontakt:
- David Bonifacic, MD
- E-mail: david.bonifacic@uniri.hr
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
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Główny śledczy:
- David Bonifacic, MD
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Zagreb, Chorwacja
- Jeszcze nie rekrutacja
- University Hospital Center Zagreb
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
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Kontakt:
- Katarina Rados, MD
- E-mail: bmalojcic@gmail.com; sodaritek@gmail.com
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Główny śledczy:
- Katarina Rados, MD
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Lisbon, Portugalia, 1150-199
- Rekrutacyjny
- ULS São José
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
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Kontakt:
- Diana A Sousa, MD, PhD
- Numer telefonu: +35121 884 10 00
- E-mail: diana.cardoso@ulssjose.min-saude.pt
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Główny śledczy:
- Diana A Sousa, MD, PhD
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Coimbra District
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Coimbra, Coimbra District, Portugalia, 3004-561
- Rekrutacyjny
- Unidade Local de Saude de Coimbra
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
- Numer telefonu: 8408 +351 239 400 400
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
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Główny śledczy:
- Joao Sargento Freitas, MD, PhD
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Lisbon District
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Lisbon, Lisbon District, Portugalia, 1649-028
- Jeszcze nie rekrutacja
- Unidade Local de Saúde de Santa Maria
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Kontakt:
- Ana Catarina Fonseca, MD
- Numer telefonu: +351 21 780 5000
- E-mail: contactcenter@ulssm.min-saude.pt
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
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Główny śledczy:
- Ana Catarina Fonseca, MD
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Matosinhos
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Porto, Matosinhos, Portugalia, 4464-513
- Rekrutacyjny
- Unidade Local de Saude de Matosinhos
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center
- E-mail: ctu-cacc@ulscoimbra.min-saude.pt
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Kontakt:
- Cristina Duque, MD
- Numer telefonu: +351229391000
- E-mail: cristina.duque@ulsm.min-saude.pt
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Główny śledczy:
- Cristina Duque, MD
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Porto District
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Porto, Porto District, Portugalia, 4200-319
- Jeszcze nie rekrutacja
- Unidade Local de Saúde de São João
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Kontakt:
- Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
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Kontakt:
- Pedro Miguel Castro, MD
- Numer telefonu: +351 225 512 100
- E-mail: pedromacc@gmail.com
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Główny śledczy:
- Pedro Miguel Castro, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patients diagnosed with ischemic stroke aged 18 years or older;
- Ability to undergo carotid and transcranial Doppler ultrasound, as well as to mobilize within 48 hours;
- Informed consent obtained from the patient or legal representative.
Exclusion Criteria:
- Pre-existing disability with a modified Rankin Scale (mRS) score ≥ 4;
- Diagnosis of Transient Ischemic Attack (TIA);
- Severe hemodynamic instability, defined as:
- Systolic blood pressure < 100 mmHg or > 220 mmHg;
- Peripheral oxygen saturation < 92%;
- Heart rate < 40 or > 112 beats per minute;
- Body temperature > 38.5°C;
- Neurological deterioration with altered level of consciousness (defined as Glasgow Coma Scale < 10);
- Patients who underwent neurosurgical intervention within the past 30 days;
- Concomitant diagnosis of a rapidly progressive fatal disease (e.g., terminal-stage cancer);
- Requirement for continuous monitoring or continuous intravenous drug infusion;
- Acute deep vein thrombosis/pulmonary embolism.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: Doppler-guided early mobilization
Patients with ischemic stroke will be mobilized based on the results of carotid and transcranial Doppler ultrasound examinations. If significant hemodynamic alterations are identified, such as stenosis ≥70% or intracranial occlusions, mobilization will be gradually introduced up to the 5th-7th day post-event. In the absence of such alterations, mobilization will begin immediately, with out-of-bed transfer to a chair within 48 hours and gait training, if clinically feasible. |
Individualized early mobilization after ischemic stroke, guided by hemodynamic assessment using carotid and transcranial Doppler ultrasound. The type and timing of mobilization are adjusted according to the presence of significant hemodynamic alterations. |
|
Brak interwencji: Standard Care Mobilization - Control Group
Patients with ischemic stroke are mobilized according to standard clinical practice, without considering hemodynamic assessment results from Doppler ultrasound. Mobilization is introduced gradually, guided by the patient's clinical tolerance. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Functional status at 3 months after ischemic stroke
Ramy czasowe: 3 months post-stroke
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Functional status assessment at 3 months after ischemic stroke, using the modified Rankin Scale (mRS), analyzed on an ordinal scale (0-6), to measure the degree of dependence/functional impairment. Score ranges: 0-no residual symptoms (better outcome);
|
3 months post-stroke
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Neurological Assessment (NIHSS Scale)
Ramy czasowe: Day 0, 48 hours, Day 7 and Month 3
|
Neurological assessment on the 7th day after ischemic stroke, measured using the National Institutes of Health Stroke Scale score (NIHSS, from 0-42) to evaluate the severity of neurological deficits. Score ranges: 0-4: Minor Stroke (better outcome); 5-15: Moderate Stroke; 16-20: Moderate to Severe Stroke; 21-42: Severe Stroke (worse outcome). |
Day 0, 48 hours, Day 7 and Month 3
|
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Development of hospital-acquired infections
Ramy czasowe: Up to 7 days
|
Incidence of infections acquired during hospitalization |
Up to 7 days
|
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Vital signs - Body temperature
Ramy czasowe: Day 0, 48 hours, Day 7
|
Measurement of body temperature in degrees Celsius at the time of the visit |
Day 0, 48 hours, Day 7
|
|
Vital signs - Systolic and diastolic blood pressure
Ramy czasowe: Day 0, 48 hours, Day 7
|
Measurement of blood pressure in mmHg at the time of the visit |
Day 0, 48 hours, Day 7
|
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Vital signs - Heart rate
Ramy czasowe: Day 0, 48 hours, Day 7
|
Measurement of heart rate in beats per minute (bpm) at the time of the visit |
Day 0, 48 hours, Day 7
|
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Mortality
Ramy czasowe: 3 months
|
Mortality rate (%) |
3 months
|
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EQ-5D-5L
Ramy czasowe: 3 months
|
An instrument to describe and value health across a wide range of disease areas. 5-level EQ-5D (EuroQol instrument with 5 dimensions and 5 levels) version with five dimensions (five levels, categorical options): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score ranges:
|
3 months
|
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Recurrent stroke assessment
Ramy czasowe: Day 0, 48 hours, Day 7
|
Assessment of stroke recurrence after the first event, specifying the type into categories (no recurrence, new transient ischemic attack, new ischemic stroke, hemorrhagic stroke) and the time interval between events. |
Day 0, 48 hours, Day 7
|
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MONTREAL COGNITIVE ASSESSMENT (MoCA)
Ramy czasowe: Month 3
|
A brief cognitive screening tool used to assess mild cognitive impairment, score from 0-30. Score ranges: < 19: moderate to severe cognitive impairment (worse outcome); 19-25: mild cognitive impairment; > 26: normal (better outcome). |
Month 3
|
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Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: 3 months
|
Final score of the scale that assesses anxiety and depression in patients, especially those with physical illnesses (score from 0-21, wiht 14 items and each item with four-point scale, 0-3). Score ranges: 0-7: Normal - No significant symptoms of anxiety or depression (better outcome); 8-10: Borderline/Mild - Presence of symptoms that may require attention; 11 or higher: Probable Case/Severe - Clinically significan psychological disorder or "probable case" (worse outcome). |
3 months
|
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Mobility assessment
Ramy czasowe: 48 hours, Day 7, Month 3.
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Assessment of participant mobility according to categories (not yet mobilized, transfers to chair, ambulating) |
48 hours, Day 7, Month 3.
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Breath Holding Index (BHI) - measure 1
Ramy czasowe: Before 48 hours or Day 7 (if not performed previously)
|
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels. Three attempts will be performed for each participant with measurements of:
|
Before 48 hours or Day 7 (if not performed previously)
|
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Breath Holding Index (BHI) - measure 2
Ramy czasowe: Before 48 hours or Day 7 (if not performed previously)
|
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels. Three attempts will be performed for each participant with measurements of:
|
Before 48 hours or Day 7 (if not performed previously)
|
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Breath Holding Index (BHI) - measure 3
Ramy czasowe: Before 48 hours or Day 7 (if not performed previously)
|
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels. Three attempts will be performed for each participant with measurements of:
|
Before 48 hours or Day 7 (if not performed previously)
|
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Hemorrhagic transformation
Ramy czasowe: 48 hours, Day 7
|
Type of ischemic stroke complication according to hemorrhage infarction (HI) /parenchymal hemorrhage (PH) levels in brain tissue. Score: 0- No complication HI1- Hemorrhage infarction 1; HI2- Hemorrhage infarction 2; PH1- Parenchymal hemorrhage 1; PH2- Parenchymal hemorrhage 2; No follow-up CT/MRI performed. |
48 hours, Day 7
|
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Early Mobilization Decision (<48h)
Ramy czasowe: Day 0
|
Ultrasound-guided (US) mobilization: early mobilization (<48h) if no cerebral hemodynamic impairment in US; Decision - yes or no? (only for interventional group) |
Day 0
|
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Hospitalization duration
Ramy czasowe: Month 3
|
Number of days of hospitalization |
Month 3
|
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White matter lesions in neuroimaging
Ramy czasowe: Day 0
|
White matter legions in neuroimaging - ARWMC scale: 0-no lesions (better outcome); 1-focal lesions; 2-beginning confluence of lesions; 3-diffuse involvement of the entire region, with or without involvement of U fibers (worse outcome). |
Day 0
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra
- Dyrektor Studium: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 197/24 CE
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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