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Frühe Doppler-assistierte Mobilisation bei Erwachsenen nach akutem ischämischem Schlaganfall (DOP-MOBILIZE)

27. September 2026 aktualisiert von: João Sargento Freitas, Unidade Local de Saúde de Coimbra, EPE

"Frühe Doppler-assistierte Mobilisation bei Erwachsenen nach akutem ischämischem Schlaganfall - eine randomisierte klinische 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1300

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

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

Studienorte

  • Kroatien
  • Portugal
    • Coimbra District
      • Coimbra, Coimbra District, Portugal, 3004-561
        • Rekrutierung
        • Unidade Local de Saude de Coimbra
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
          • Telefonnummer: 8408 +351 239 400 400
          • E-Mail: ctu-cacc@ulscoimbra.min-saude.pt
        • Hauptermittler:
          • Joao Sargento Freitas, MD, PhD
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1649-028
        • Noch keine Rekrutierung
        • Unidade Local de Saúde de Santa Maria
        • Kontakt:
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • Hauptermittler:
          • Ana Catarina Fonseca, MD
    • Matosinhos
      • Porto, Matosinhos, Portugal, 4464-513
    • Porto District
      • Porto, Porto District, Portugal, 4200-319
        • Noch keine Rekrutierung
        • Unidade Local de Saúde de São João
        • Kontakt:
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • Kontakt:
        • Hauptermittler:
          • Pedro Miguel Castro, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: Doppler-guided early mobilization

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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional status at 3 months after ischemic stroke
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neurological Assessment (NIHSS Scale)
Zeitfenster: 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
Zeitfenster: Up to 7 days

Incidence of infections acquired during hospitalization
Up to 7 days
Vital signs - Body temperature
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 months

Mortality rate (%)
3 months
EQ-5D-5L
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Month 3

Number of days of hospitalization
Month 3
White matter lesions in neuroimaging
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Unidade Local de Saúde de Coimbra, EPE

Mitarbeiter

University Hospital Rijeka
Unidade Local de Saúde de Matosinhos, EPE
Klinički Bolnički Centar Zagreb
Unidade Local de Saúde Santa Maria
Unidade Local de Saúde de São José
Unidade Local de Saúde São João, Oporto

Ermittler

  • Hauptermittler: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra
  • Studienleiter: Joao Sargento Freitas, MD, PhD, Unidade Local de Saude de Coimbra

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Juni 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

16. September 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. November 2025

Zuerst gepostet (Tatsächlich)

18. November 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 197/24 CE

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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