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

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

This study tests whether using Doppler ultrasound to guide early out-of-bed mobilization helps adults recover better after an acute ischemic stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Unidade Local de Saúde de Coimbra, EPE (Academic / other)
• Locations: 3 sites (Coimbra, Coimbra District and 2 other locations)
• Trial ID: NCT07232498 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older hospitalized with acute ischemic stroke who can undergo carotid and transcranial Doppler and be mobilized within 48 hours are ideal candidates.

Not a fit: Patients with pre-existing severe disability (mRS ≥ 4), severe hemodynamic instability, recent neurosurgery, or inability to undergo Doppler assessment are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce complications, shorten hospital stays, and improve functional and cognitive recovery by tailoring mobilization to each patient's hemodynamic status.

How similar studies have performed: Previous early-mobilization studies have shown mixed benefits and generally did not use systematic Doppler-guided hemodynamic assessment, making this approach partially novel and not yet proven.

Eligibility criteria

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 this trial is running

Coimbra, Coimbra District and 2 other locations

• Unidade Local de Saude de Coimbra — Coimbra, Coimbra District, Portugal (Recruiting)
• Unidade Local de Saúde de Santa Maria — Lisbon, Lisbon District, Portugal (Not_yet_recruiting)
• Unidade Local de Saúde de São João — Porto, Porto 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

Conditions Arterial Ischemic Stroke; Early mobilization; mRS; Transcranial doppler ultrasound; Neurology; Hemodynamics