Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 7
- 主要终点
- Functional status at 3 months after ischemic stroke
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 双盲 (受试者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
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.
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.
干预措施: Doppler-guided early mobilization (Procedure)
结局指标
主要结局
Functional status at 3 months after ischemic stroke
时间窗: 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).
次要结局
- MONTREAL COGNITIVE ASSESSMENT (MoCA)(Month 3)
- Early Mobilization Decision (<48h)(Day 0)
- Hospitalization duration(Month 3)
- White matter lesions in neuroimaging(Day 0)
- Neurological Assessment (NIHSS Scale)(Day 0, 48 hours, Day 7 and Month 3)
- Development of hospital-acquired infections(Up to 7 days)
- Vital signs - Body temperature(Day 0, 48 hours, Day 7)
- Vital signs - Systolic and diastolic blood pressure(Day 0, 48 hours, Day 7)
- Mortality(3 months)
- Vital signs - Heart rate(Day 0, 48 hours, Day 7)
- Breath Holding Index (BHI) - measure 1(Before 48 hours or Day 7 (if not performed previously))
- EQ-5D-5L(3 months)
- Recurrent stroke assessment(Day 0, 48 hours, Day 7)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
- Mobility assessment(48 hours, Day 7, Month 3.)
- Breath Holding Index (BHI) - measure 2(Before 48 hours or Day 7 (if not performed previously))
- Breath Holding Index (BHI) - measure 3(Before 48 hours or Day 7 (if not performed previously))
- Hemorrhagic transformation(48 hours, Day 7)
研究者
João Sargento Freitas
Principal Investigator, MD, PhD, Stroke Unit Coordinator
Unidade Local de Saúde de Coimbra, EPE
研究点 (7)
标识符
- NCT 编号
- NCT07232498
- 其他研究编号
- 197/24 CE
日期
- 首次提交
- (去年)
- 首次发布
- (10个月前)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.