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Raná dopplerem asistovaná mobilizace u dospělých po akutní ischemické cévní mozkové příhodě (DOP-MOBILIZE)

27. září 2026 aktualizováno: João Sargento Freitas, Unidade Local de Saúde de Coimbra, EPE

Raně Dopplerem asistovaná mobilizace u dospělých po akutní ischemické cévní mozkové příhodě - randomizovaná klinická studie

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

1300

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
  • Telefonní číslo: 8408 +351 239 400 400
  • E-mail: ctu-cacc@ulscoimbra.min-saude.pt

Studijní místa

    • Coimbra District
      • Coimbra, Coimbra District, Portugalsko, 3004-561
        • Nábor
        • Unidade Local de Saude de Coimbra
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
          • Telefonní číslo: 8408 +351 239 400 400
          • E-mail: ctu-cacc@ulscoimbra.min-saude.pt
        • Vrchní vyšetřovatel:
          • Joao Sargento Freitas, MD, PhD
    • Lisbon District
      • Lisbon, Lisbon District, Portugalsko, 1649-028
        • Zatím nenabíráme
        • Unidade Local de Saúde de Santa Maria
        • Kontakt:
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • Vrchní vyšetřovatel:
          • Ana Catarina Fonseca, MD
    • Matosinhos
      • Porto, Matosinhos, Portugalsko, 4464-513
    • Porto District
      • Porto, Porto District, Portugalsko, 4200-319
        • Zatím nenabíráme
        • Unidade Local de Saúde de São João
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Pedro Miguel Castro, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Žádný zásah: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional status at 3 months after ischemic stroke
Časové okno: 3 months post-stroke

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);

  1. no significant disability;
  2. slight disability;
  3. moderate disability;
  4. moderately severe disability;
  5. severe disability;
  6. death (worse outcome).
3 months post-stroke

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neurological Assessment (NIHSS Scale)
Časové okno: 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
Development of hospital-acquired infections
Časové okno: Up to 7 days

Incidence of infections acquired during hospitalization

Up to 7 days
Vital signs - Body temperature
Časové okno: 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
Časové okno: Day 0, 48 hours, Day 7

Measurement of blood pressure in mmHg at the time of the visit

Day 0, 48 hours, Day 7
Vital signs - Heart rate
Časové okno: 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
Mortality
Časové okno: 3 months

Mortality rate (%)

3 months
EQ-5D-5L
Časové okno: 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:

  1. I have no problems ...walking/dressing, etc (better outcome);
  2. I have some problems ...walking/dressing, etc;
  3. I have moderate problems ...walking/dressing, etc;
  4. I have severe problems ...walking/dressing, etc;
  5. I have extreme problems ...walking/dressing, etc (worse outcome).
3 months
Recurrent stroke assessment
Časové okno: 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
MONTREAL COGNITIVE ASSESSMENT (MoCA)
Časové okno: 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
Hospital Anxiety and Depression Scale (HADS)
Časové okno: 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
Mobility assessment
Časové okno: 48 hours, Day 7, Month 3.

Assessment of participant mobility according to categories (not yet mobilized, transfers to chair, ambulating)

48 hours, Day 7, Month 3.
Breath Holding Index (BHI) - measure 1
Časové okno: 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:

  • (a) baseline mean flow velocity before the apnea test (cm/sec)
Before 48 hours or Day 7 (if not performed previously)
Breath Holding Index (BHI) - measure 2
Časové okno: 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:

  • (b) mean flow velocity at the end of the apnea test (cm/sec).
Before 48 hours or Day 7 (if not performed previously)
Breath Holding Index (BHI) - measure 3
Časové okno: 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:

  • (c) apnea duration (sec).
Before 48 hours or Day 7 (if not performed previously)
Hemorrhagic transformation
Časové okno: 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
Early Mobilization Decision (<48h)
Časové okno: 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
Hospitalization duration
Časové okno: Month 3

Number of days of hospitalization

Month 3
White matter lesions in neuroimaging
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra
  • Ředitel studie: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. června 2025

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

16. září 2025

První předloženo, které splnilo kritéria kontroly kvality

14. listopadu 2025

První zveřejněno (Aktuální)

18. listopadu 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 197/24 CE

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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