NCT Number: NCT07232498
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Unidade Local de Saude de Coimbra, Coimbra, Coimbra District, Portugal
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 48 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months post-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);
Time frame: Day 0, 48 hours, Day 7 and Month 3
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: Up to 7 days
Incidence of infections acquired during hospitalization
Time frame: Day 0, 48 hours, Day 7
Measurement of body temperature in degrees Celsius at the time of the visit
Time frame: Day 0, 48 hours, Day 7
Measurement of blood pressure in mmHg at the time of the visit
Time frame: Day 0, 48 hours, Day 7
Measurement of heart rate in beats per minute (bpm) at the time of the visit
Time frame: 3 months
Mortality rate (%)
Time frame: 3 months
An instrument to describe and value health across a wide range of disease areas.
5-level EQ-5D (EuroQol instrument with 5 dimensions and 5 levels) version with five dimensions (five levels, categorical options): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Score ranges:
Time frame: Day 0, 48 hours, Day 7
Assessment of stroke recurrence after the first event, specifying the type into categories (no recurrence, new transient ischemic attack, new ischemic stroke, hemorrhagic stroke) and the time interval between events.
Time frame: Month 3
A brief cognitive screening tool used to assess mild cognitive impairment, score from 0-30.
Score ranges:
< 19: moderate to severe cognitive impairment (worse outcome); 19-25: mild cognitive impairment; > 26: normal (better outcome).
Time frame: 3 months
Final score of the scale that assesses anxiety and depression in patients, especially those with physical illnesses (score from 0-21, wiht 14 items and each item with four-point scale, 0-3).
Score ranges:
0-7: Normal - No significant symptoms of anxiety or depression (better outcome); 8-10: Borderline/Mild - Presence of symptoms that may require attention; 11 or higher: Probable Case/Severe - Clinically significan psychological disorder or "probable case" (worse outcome).
Time frame: 48 hours, Day 7, Month 3.
Assessment of participant mobility according to categories (not yet mobilized, transfers to chair, ambulating)
Time frame: Before 48 hours or Day 7 (if not performed previously)
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels.
Three attempts will be performed for each participant with measurements of:
Time frame: Before 48 hours or Day 7 (if not performed previously)
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels.
Three attempts will be performed for each participant with measurements of:
Time frame: Before 48 hours or Day 7 (if not performed previously)
Non-invasive method used to assess cerebrovascular reactivity, specifically the ability of the brain's blood vessels to adjust to changes in carbon dioxide levels.
Three attempts will be performed for each participant with measurements of:
Time frame: 48 hours, Day 7
Type of ischemic stroke complication according to hemorrhage infarction (HI) /parenchymal hemorrhage (PH) levels in brain tissue.
Score:
0- No complication HI1- Hemorrhage infarction 1; HI2- Hemorrhage infarction 2; PH1- Parenchymal hemorrhage 1; PH2- Parenchymal hemorrhage 2; No follow-up CT/MRI performed.
Time frame: Day 0
Ultrasound-guided (US) mobilization: early mobilization (<48h) if no cerebral hemodynamic impairment in US; Decision - yes or no? (only for interventional group)
Time frame: Month 3
Number of days of hospitalization
Time frame: Day 0
White matter legions in neuroimaging - ARWMC scale: 0-no lesions (better outcome); 1-focal lesions; 2-beginning confluence of lesions; 3-diffuse involvement of the entire region, with or without involvement of U fibers (worse outcome).
Contact information is provided by the study sponsor or research team.
Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
CONTACT
+351 239 400 400 ext. 8408
Joao Sargento Freitas, MD, PhD
CONTACT
Unidade Local de Saúde de Coimbra, EPE
Other
Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke - a Randomized Clinical Trial
Acronym: DOP-MOBILIZE
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