Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)

Study Overview
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Brief Summary
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The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。

Detailed Description
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Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.

Official Title
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Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: head-down position treatment
* Other: Conventional Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years acute ischemic stroke within 10 - 30 days of onset neurological deficit: 6≤NIHSS≤16 Large artery atherosclerosis stroke based on TOAST criteria The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%. first stroke onset or past stroke without obvious neurological deficit (mRS≤1) fully understand and cooperate with the doctor's instructions. the availability of informed consent; Exclusion Criteria: Hemorrhagic stroke or mixed stroke Combining with severe organ dysfunction Past hemorrhagic stroke A history of stroke with severe sequelae Planning revascularization in 3 months Ischemic stroke due to surgical intervention participating in other clinical trials within 3 months Pregnant or lactating women any inappropriate patients assessed by the researcher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head down position<br>head-down position treatment combined with conventional rehabilitation. | Other: head-down position treatment<br>* In the head-down position, the body is in the supine position with the head lowered to 30 degrees<br>Other: Conventional Rehabilitation<br>* The body is in the supine position without lowered head<br>|
| Sham Comparator: Conventional Rehabilitation<br>Conventional rehabilitation treatment | Other: Conventional Rehabilitation<br>* The body is in the supine position without lowered head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with modified Rankin Score 0 to 2 |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with modified Rankin Score 0 to 1 |  | 90 days | 
| The percentage of reduction in Fugl-Meyer score |  | 90 days | 
| occurrence of stroke | stroke or TIA | 90 days | 
| The percentage of reduction in MMSE | MMSE，Mini-mental State Examination | 90 days | 
| The percentage of reduction in MoCA | MoCA, Montreal Congnitive Assessment | 90 days | 
| Incidence of major vascular events | ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death | 90 days | 
| the biggest tolerance time of head-down |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head-down position, ischemic stroke, rehabilitation