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成人急性缺血性脑卒中后早期多普勒辅助活动 (DOP-MOBILIZE)

2026年9月27日 更新者：João Sargento Freitas、Unidade Local de Saúde de Coimbra, EPE

成人急性缺血性脑卒中后早期多普勒辅助下活动 - 一项随机临床试验

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

1300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
  • 电话号码：8408 +351 239 400 400
  • 邮箱：ctu-cacc@ulscoimbra.min-saude.pt

学习地点

  • 克罗地亚
  • 葡萄牙
    • Coimbra District
      • Coimbra、Coimbra District、葡萄牙、3004-561
        • 招聘中
        • Unidade Local de Saude de Coimbra
        • 接触：
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC Unidade Local de Saude de Coimbra
          • 电话号码：8408 +351 239 400 400
          • 邮箱：ctu-cacc@ulscoimbra.min-saude.pt
        • 首席研究员：
          • Joao Sargento Freitas, MD, PhD
    • Lisbon District
      • Lisbon、Lisbon District、葡萄牙、1649-028
        • 尚未招聘
        • Unidade Local de Saúde de Santa Maria
        • 接触：
        • 接触：
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • 首席研究员：
          • Ana Catarina Fonseca, MD
    • Matosinhos
      • Porto、Matosinhos、葡萄牙、4464-513
    • Porto District
      • Porto、Porto District、葡萄牙、4200-319
        • 尚未招聘
        • Unidade Local de Saúde de São João
        • 接触：
          • Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC
        • 接触：
        • 首席研究员：
          • Pedro Miguel Castro, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Doppler-guided early mobilization

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.
程序：Doppler-guided early mobilization

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.
无干预：Standard Care Mobilization - Control Group

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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Functional status at 3 months after ischemic stroke
大体时间：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);

  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

次要结果测量

结果测量
措施说明
大体时间
Neurological Assessment (NIHSS Scale)
大体时间：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).
Day 0, 48 hours, Day 7 and Month 3
Development of hospital-acquired infections
大体时间：Up to 7 days

Incidence of infections acquired during hospitalization
Up to 7 days
Vital signs - Body temperature
大体时间：Day 0, 48 hours, Day 7

Measurement of body temperature in degrees Celsius at the time of the visit
Day 0, 48 hours, Day 7
Vital signs - Systolic and diastolic blood pressure
大体时间：Day 0, 48 hours, Day 7

Measurement of blood pressure in mmHg at the time of the visit
Day 0, 48 hours, Day 7
Vital signs - Heart rate
大体时间：Day 0, 48 hours, Day 7

Measurement of heart rate in beats per minute (bpm) at the time of the visit
Day 0, 48 hours, Day 7
Mortality
大体时间：3 months

Mortality rate (%)
3 months
EQ-5D-5L
大体时间：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:

  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).
3 months
Recurrent stroke assessment
大体时间：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.
Day 0, 48 hours, Day 7
MONTREAL COGNITIVE ASSESSMENT (MoCA)
大体时间：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).
Month 3
Hospital Anxiety and Depression Scale (HADS)
大体时间：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).
3 months
Mobility assessment
大体时间：48 hours, Day 7, Month 3.

Assessment of participant mobility according to categories (not yet mobilized, transfers to chair, ambulating)
48 hours, Day 7, Month 3.
Breath Holding Index (BHI) - measure 1
大体时间：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:

  • (a) baseline mean flow velocity before the apnea test (cm/sec)
Before 48 hours or Day 7 (if not performed previously)
Breath Holding Index (BHI) - measure 2
大体时间：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:

  • (b) mean flow velocity at the end of the apnea test (cm/sec).
Before 48 hours or Day 7 (if not performed previously)
Breath Holding Index (BHI) - measure 3
大体时间：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:

  • (c) apnea duration (sec).
Before 48 hours or Day 7 (if not performed previously)
Hemorrhagic transformation
大体时间：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.
48 hours, Day 7
Early Mobilization Decision (<48h)
大体时间：Day 0

Ultrasound-guided (US) mobilization: early mobilization (<48h) if no cerebral hemodynamic impairment in US; Decision - yes or no? (only for interventional group)
Day 0
Hospitalization duration
大体时间：Month 3

Number of days of hospitalization
Month 3
White matter lesions in neuroimaging
大体时间：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).
Day 0

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Unidade Local de Saúde de Coimbra, EPE

合作者

University Hospital Rijeka
Unidade Local de Saúde de Matosinhos, EPE
Klinički Bolnički Centar Zagreb
Unidade Local de Saúde Santa Maria
Unidade Local de Saúde de São José
Unidade Local de Saúde São João, Oporto

调查人员

  • 首席研究员：Joao Sargento Freitas, MD, PhD、Unidade Local de Saude de Coimbra
  • 研究主任：Joao Sargento Freitas, MD, PhD、Unidade Local de Saude de Coimbra

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月4日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2025年9月16日

首先提交符合 QC 标准的

2025年11月14日

首次发布 (实际的)

2025年11月18日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月27日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 197/24 CE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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