RecruitingNot ApplicableNCT07232498

Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke - a Randomized Clinical Trial


Sponsor

Unidade Local de Saúde de Coimbra, EPE

Enrollment

1,300 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria12

  • 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.

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Interventions

PROCEDUREDoppler-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.


Locations(3)

Unidade Local de Saude de Coimbra

Coimbra, Coimbra District, Portugal

Unidade Local de Saúde de Santa Maria

Lisbon, Lisbon District, Portugal

Unidade Local de Saúde de São João

Porto, Porto District, Portugal

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NCT07232498