Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnidade Local de Saúde de Coimbra, EPE

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Doppler-guided early mobilization

    Procedure/Surgery

    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.

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Doppler-guided early mobilizationExperimental treatment 1 intervention
Group B: Standard Care Mobilization - Control GroupNo intervention 0 interventions

Trial outcomes

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).

Time frame
3 months post-stroke

Secondary outcomes

1

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).

Time frame
Day 0, 48 hours, Day 7 and Month 3
2

Development of hospital-acquired infections

Incidence of infections acquired during hospitalization

Time frame
Up to 7 days
3

Vital signs - Body temperature

Measurement of body temperature in degrees Celsius at the time of the visit

Time frame
Day 0, 48 hours, Day 7
4

Vital signs - Systolic and diastolic blood pressure

Measurement of blood pressure in mmHg at the time of the visit

Time frame
Day 0, 48 hours, Day 7

Other outcomes

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