Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

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.

• Neurological Assessment (NIHSS Scale) [Срок оценки: Day 0, 48 hours, Day 7 and Month 3]
• Development of hospital-acquired infections [Срок оценки: Up to 7 days]
• Vital signs - Body temperature [Срок оценки: Day 0, 48 hours, Day 7]
• Vital signs - Systolic and diastolic blood pressure [Срок оценки: Day 0, 48 hours, Day 7]
• Vital signs - Heart rate [Срок оценки: Day 0, 48 hours, Day 7]
• Mortality [Срок оценки: 3 months]
• EQ-5D-5L [Срок оценки: 3 months]
• Recurrent stroke assessment [Срок оценки: Day 0, 48 hours, Day 7]
• MONTREAL COGNITIVE ASSESSMENT (MoCA) [Срок оценки: Month 3]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 3 months]
• Mobility assessment [Срок оценки: 48 hours, Day 7, Month 3.]
• Breath Holding Index (BHI) - measure 1 [Срок оценки: Before 48 hours or Day 7 (if not performed previously)]