Cerebral Blood Flow-guided Early Rehabilitation Intervention After Stroke: a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Postural Assessment Scale for Stroke
研究概览
简要总结
The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF. However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear Recently, it was suggested that the benefit of early mobilization (EM) after stroke on motor recovery may be outweighed by a deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. Hypothetically, EM could improve recovery outcomes after stroke in selected patients based on CA function. Our objective is to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA and evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside. The investigators designed a randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be recruited and randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit during the first mobilization. Randomization will be stratified by stroke severity and type of stroke. Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.
详细描述
Background: The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF.
However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear. The results of AVERT trial suggested that the benefit of early mobilization (EM) after stroke on functional outcome may be outweighed by a hypothetical deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. EM could improve recovery outcomes after stroke in selected patients based on the status of CA function.
Objectives: 1) to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA. 2) To evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside.
Methodology: A randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit. Randomization will be stratified according to stroke severity measured with the National institute of Health Stroke Scale (NIHSS) and type of stroke (ischemic or hemorrhagic). Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.
Expected results: to provide a new in vivo biomarker of cerebrovascular function for more accurate and earlier prediction of response to therapy, leading to improved clinical decisions and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years or over, with a clinical diagnosis of first or recurrent stroke, either ischemic or hemorrhagic.
- •Recruitment within 24 hours of onset of stroke symptoms.
- •Admission to the stroke unit
- •Informed consent obtained from the patient or responsible third party
排除标准
- •Pre-stroke modified Rankin scale score >3
- •Transient ischemic attacks
- •Exclusively retinal stroke
- •Deterioration in patient´s neurological condition in the first hours of admission resulting in urgent surgery, admission to ICU or a documented decision for palliative care.
- •Unstable medical condition
- •A suspected or confirmed lower limb fracture at the time of stroke preventing the implementation of the mobilization protocol.
结局指标
主要结局
Postural Assessment Scale for Stroke
时间窗: 90 days
Balance and mobility assessed with the Postural Assessment Scale for Stroke patients (PASS), in its validated Spanish version. The PASS contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. Each item is scored from 0 to 3, with 0 being the lowest level of functionality and 3 the highest. The total score ranges from 0 to 36 (highest score best).
次要结局
- Modified Rankin scale(90 days)
- Neurological deterioration measured with the NIHSS(14 days)
- Health-related quality of life(Discharge and 90 days)
- Recurrent Stroke(90 days)
- Falls after stroke(90 days)