NCT07232498

Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Unidade Local de Saúde de Coimbra, EPE · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 72 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.

Conditions

• Arterial Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-06-04
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-11-18
• Last updated: 2026-01-29

Locations

3 sites across 1 country: Portugal