Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

NCT ID: NCT07232498

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Doppler-guided early mobilization

Patients with ischemic stroke will be mobilized based on the results of carotid and transcranial Doppler ultrasound examinations. If significant hemodynamic alterations are identified, such as stenosis ≥70% or intracranial occlusions, mobilization will be gradually introduced up to the 5th-7th day post-event. In the absence of such alterations, mobilization will begin immediately, with out-of-bed transfer to a chair within 48 hours and gait training, if clinically feasible.

Group Type: EXPERIMENTAL

Doppler-guided early mobilization

Intervention Type: PROCEDURE

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.

Standard Care Mobilization - Control Group

Patients with ischemic stroke are mobilized according to standard clinical practice, without considering hemodynamic assessment results from Doppler ultrasound. Mobilization is introduced gradually, guided by the patient's clinical tolerance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidade Local de Saúde São João

OTHER_GOV

Sponsor Role: collaborator

Unidade Local de Saúde Santa Maria

OTHER_GOV

Sponsor Role: collaborator

Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role: lead

Responsible Party

João Sargento Freitas

Principal Investigator, MD, PhD, Stroke Unit Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joao Sargento Freitas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saude de Coimbra

Joao Sargento Freitas, MD, PhD

Role: STUDY_DIRECTOR

Unidade Local de Saude de Coimbra

Locations

Unidade Local de Saude de Coimbra

Coimbra, Coimbra District, Portugal

Site Status: RECRUITING

Unidade Local de Saúde de Santa Maria

Lisbon, Lisbon District, Portugal

Site Status: NOT_YET_RECRUITING

Unidade Local de Saúde de São João

Porto, Porto District, Portugal

Site Status: NOT_YET_RECRUITING

Countries

Portugal

Central Contacts

Joao Sargento Freitas, MD, PhD

Role: CONTACT

joaosargentofreitas@ulscoimbra.min-saude.pt

+351 239 400 400

Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra

Role: CONTACT

ctu-cacc@ulscoimbra.min-saude.pt

+351 239 400 400 ext. 8408

Facility Contacts

Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra

Role: primary

ctu-cacc@ulscoimbra.min-saude.pt

+351 239 400 400 ext. 8408

Ana Catarina Fonseca, MD

Role: primary

contactcenter@ulssm.min-saude.pt

+351 21 780 5000

Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC

Role: backup

Pedro Miguel Castro, MD

Role: primary

pedromacc@gmail.com

+351 225 512 100

Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC

Role: backup

Other Identifiers

197/24 CE

Identifier Type: -

Identifier Source: org_study_id