About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pre-existing disability with a modified Rankin Scale (mRS) score ≥ 4;
Diagnosis of Transient Ischemic Attack (TIA);
Systolic blood pressure < 100 mmHg or > 220 mmHg;
Peripheral oxygen saturation < 92%;
Trial design
Parallel
Treatments tested in this trial
Doppler-guided early mobilization
Procedure/SurgeryIndividualized 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Neurological Assessment (NIHSS Scale)
Neurological assessment on the 7th day after ischemic stroke, measured using the National Institutes of Health Stroke Scale score (NIHSS, from 0-42) to evaluate the severity of neurological deficits. Score ranges: 0-4: Minor Stroke (better outcome); 5-15: Moderate Stroke; 16-20: Moderate to Severe Stroke; 21-42: Severe Stroke (worse outcome).
Development of hospital-acquired infections
Incidence of infections acquired during hospitalization
Vital signs - Body temperature
Measurement of body temperature in degrees Celsius at the time of the visit
Vital signs - Systolic and diastolic blood pressure
Measurement of blood pressure in mmHg at the time of the visit
Sponsors and contacts
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Unidade Local de Saúde de Coimbra, EPE
Lead sponsor
Unidade Local de Saúde São João
Collaborator
Unidade Local de Saúde Santa Maria
Collaborator
Unidade Local de Saúde de Matosinhos, EPE
Collaborator
University Hospital Rijeka
Collaborator
Unidade Local de Saúde de São José
Collaborator
Klinički Bolnički Centar Zagreb
Collaborator