Doppler-guided early out-of-bed mobilization after acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, pragmatic, randomized controlled trial with a PROBE design that assigns adults with acute ischemic stroke to Doppler-guided early mobilization within 48 hours versus standard care. Clinicians use carotid and transcranial Doppler ultrasound to evaluate hemodynamic stability and determine timing and intensity of initial mobilization. Blinded outcome assessors measure three-month outcomes including the modified Rankin Scale, cognitive function, quality of life, patient-reported outcomes, length of stay, blood pressure evolution, and adverse events. The trial is conducted at neurology departments in Coimbra, Lisbon, and Porto to provide practical evidence for tailoring early mobilization after stroke.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unidade Local de Saude de Coimbra
  Coimbra, Coimbra District, Portugal Recruiting
• Unidade Local de Saude de Matosinhos
  Porto, Matosinhos, Portugal Recruiting
• ULS São José
  Lisbon, Portugal Recruiting
• University Hospital Rijeka
  Rijeka, Croatia Not yet recruiting
• University Hospital Center Zagreb
  Zagreb, Croatia Not yet recruiting
• Unidade Local de Saúde de Santa Maria
  Lisbon, Lisbon District, Portugal Not yet recruiting

Study contacts

• Principal investigator: Joao Sargento Freitas, MD, PhD — Unidade Local de Saude de Coimbra
• Study coordinator: Joao Sargento Freitas, MD, PhD
• Email: joaosargentofreitas@ulscoimbra.min-saude.pt
• Phone: +351 239 400 400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.