Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

NCT07232498 | Recruiting

• 1 other identifier: 197/24 CE
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 3

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.

Conditions

Arterial Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Functional status at 3 months after ischemic stroke

  Functional status assessment at 3 months after ischemic stroke, using the modified Rankin Scale (mRS), analyzed on an ordinal scale (0-6), to measure the degree of dependence/functional impairment. Score ranges: 0-no residual symptoms (better outcome); 1. no significant disability; 2. slight disability; 3. moderate disability; 4. moderately severe disability; 5. severe disability; 6. death (worse outcome).

  3 months post-stroke

Secondary Outcomes (18)

• Neurological Assessment (NIHSS Scale)

  Day 0, 48 hours, Day 7 and Month 3

• Development of hospital-acquired infections

  Up to 7 days

• Vital signs - Body temperature

  Day 0, 48 hours, Day 7

• Vital signs - Systolic and diastolic blood pressure

  Day 0, 48 hours, Day 7

• Vital signs - Heart rate

  Day 0, 48 hours, Day 7

Study Arms (2)

Doppler-guided early mobilization

EXPERIMENTAL

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.

Procedure: Doppler-guided early mobilization

Standard Care Mobilization - Control Group

NO INTERVENTION

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.

Interventions

Doppler-guided early mobilization 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.

Doppler-guided early mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead
• Unidade Local de Saúde São João: collaborator
• Unidade Local de Saúde Santa Maria: collaborator

Study Sites (3)

Unidade Local de Saude de Coimbra

Coimbra, Coimbra District, 3004-561, Portugal

RECRUITING

Unidade Local de Saúde de Santa Maria

Lisbon, Lisbon District, 1649-028, Portugal

NOT YET RECRUITING

Unidade Local de Saúde de São João

Porto, Porto District, 4200-319, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joao Sargento Freitas, MD, PhD

  Unidade Local de Saude de Coimbra

  PRINCIPAL INVESTIGATOR

• Joao Sargento Freitas, MD, PhD

  Unidade Local de Saude de Coimbra

  STUDY DIRECTOR

Central Study Contacts

Joao Sargento Freitas, MD, PhD

CONTACT

+351 239 400 400; joaosargentofreitas@ulscoimbra.min-saude.pt

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

CONTACT

+351 239 400 400; ctu-cacc@ulscoimbra.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD, Stroke Unit Coordinator

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 18, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)