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Arterial Ischemic StrokeDOP-MOBILIZENCT07232498

Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke

A study testing Doppler-guided early mobilization in people with Arterial Ischemic Stroke, run by Unidade Local de Saúde de Coimbra, EPE at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arterial Ischemic Stroke
What is being tested?
Doppler-guided early mobilization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
7 sitesin 2 countries
Study dates
4 Jun 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

+351 239 400 400 ext. 8408

ctu-cacc@ulscoimbra.min-saude.pt

7 sites in 2 countries

Portugal5 sites, 5 recruiting
  • Unidade Local de Saude de Coimbra

    Coimbra, Coimbra District, 3004-561

    Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra, +351 239 400 400 ext. 8408, ctu-cacc@ulscoimbra.min-saude.pt

    Joao Sargento Freitas, MD, PhD

    Recruiting
  • Unidade Local de Saúde de Santa Maria

    Lisbon, Lisbon District, 1649-028

    Ana Catarina Fonseca, MD, +351 21 780 5000, contactcenter@ulssm.min-saude.pt

    Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC

    Not yet recruiting
  • ULS São José

    Lisbon, 1150-199

    Diana A Sousa, MD, PhD, +35121 884 10 00, diana.cardoso@ulssjose.min-saude.pt

    Clinical Trials Unit - Coimbra Academic Clinical Center, ctu-cacc@ulscoimbra.min-saude.pt

    Recruiting
  • Unidade Local de Saude de Matosinhos

    Porto, Matosinhos, 4464-513

    Cristina Duque, MD, +351229391000, cristina.duque@ulsm.min-saude.pt

    Clinical Trials Unit - Coimbra Academic Clinical Center, ctu-cacc@ulscoimbra.min-saude.pt

    Recruiting
  • Unidade Local de Saúde de São João

    Porto, Porto District, 4200-319

    Pedro Miguel Castro, MD, +351 225 512 100, pedromacc@gmail.com

    Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC

    Not yet recruiting

Other trials in Portugal

Croatia2 sites, 2 recruiting
  • University Hospital Rijeka

    Rijeka

    David Bonifacic, MD, david.bonifacic@uniri.hr

    Clinical Trials Unit - Coimbra Academic Clinical Center, ctu-cacc@ulscoimbra.min-saude.pt

    Not yet recruiting
  • University Hospital Center Zagreb

    Zagreb

    Katarina Rados, MD, bmalojcic@gmail.com; sodaritek@gmail.com

    Clinical Trials Unit - Coimbra Academic Clinical Center, ctu-cacc@ulscoimbra.min-saude.pt

    Not yet recruiting

Other trials in Croatia

About this study

Official title: Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke - a Randomized Clinical 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.

Read the 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 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.

Being tested
Doppler-guided early mobilization
Keywords
Arterial Ischemic Stroke, Early mobilization, mRS, Transcranial doppler ultrasound, Neurology, Hemodynamics
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doppler-guided early mobilizationProcedure or 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.

Study groups in NCT07232498
Study groupRoleWhat they receive
Doppler-guided early mobilizationExperimentalPatients 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.
Receives: Procedure: Doppler-guided early mobilization
Standard Care Mobilization - Control GroupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 months post-stroke

Secondary outcomes (18)
  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).

    Measured: Day 0, 48 hours, Day 7 and Month 3

  2. Development of hospital-acquired infections

    Incidence of infections acquired during hospitalization

    Measured: Up to 7 days

  3. Vital signs - Body temperature

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

    Measured: 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

    Measured: Day 0, 48 hours, Day 7

  5. Vital signs - Heart rate

    Measurement of heart rate in beats per minute (bpm) at the time of the visit

    Measured: Day 0, 48 hours, Day 7

  6. Mortality

    Mortality rate (%)

    Measured: 3 months

  7. EQ-5D-5L

    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:

    1. I have no problems ...walking/dressing, etc (better outcome);
    2. I have some problems ...walking/dressing, etc;
    3. I have moderate problems ...walking/dressing, etc;
    4. I have severe problems ...walking/dressing, etc;
    5. I have extreme problems ...walking/dressing, etc (worse outcome).

    Measured: 3 months

  8. Recurrent stroke assessment

    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.

    Measured: Day 0, 48 hours, Day 7

  9. MONTREAL COGNITIVE ASSESSMENT (MoCA)

    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).

    Measured: Month 3

  10. Hospital Anxiety and Depression Scale (HADS)

    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).

    Measured: 3 months

  11. Mobility assessment

    Assessment of participant mobility according to categories (not yet mobilized, transfers to chair, ambulating)

    Measured: 48 hours, Day 7, Month 3.

  12. Breath Holding Index (BHI) - measure 1

    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:

    • (a) baseline mean flow velocity before the apnea test (cm/sec)

    Measured: Before 48 hours or Day 7 (if not performed previously)

  13. Breath Holding Index (BHI) - measure 2

    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:

    • (b) mean flow velocity at the end of the apnea test (cm/sec).

    Measured: Before 48 hours or Day 7 (if not performed previously)

  14. Breath Holding Index (BHI) - measure 3

    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:

    • (c) apnea duration (sec).

    Measured: Before 48 hours or Day 7 (if not performed previously)

  15. Hemorrhagic transformation

    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.

    Measured: 48 hours, Day 7

  16. Early Mobilization Decision (<48h)

    Ultrasound-guided (US) mobilization: early mobilization (<48h) if no cerebral hemodynamic impairment in US; Decision - yes or no? (only for interventional group)

    Measured: Day 0

  17. Hospitalization duration

    Number of days of hospitalization

    Measured: Month 3

  18. White matter lesions in neuroimaging

    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).

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start4 Jun 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232498
Sponsor's protocol ID
197/24 CE
Acronym
DOP-MOBILIZE
Status last verified
Sep 2026
First submitted
16 Sep 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.

Questions about this trial

What is this clinical trial studying?

A study testing Doppler-guided early mobilization in people with Arterial Ischemic Stroke, run by Unidade Local de Saúde de Coimbra, EPE at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Portugal, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joao Sargento Freitas, MD, PhD (+351 239 400 400, joaosargentofreitas@ulscoimbra.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional status at 3 months after ischemic stroke (time frame: 3 months post-stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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