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

Not Applicable

Terminated

• Conditions: Ischemic Stroke
• Interventions: Other: head-down position treatment; Other: Conventional Rehabilitation

• Registration Number: NCT03629652
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-08-06
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. age ≥18 years
2. acute ischemic stroke within 10 - 30 days of onset
3. neurological deficit: 6≤NIHSS≤16
4. Large artery atherosclerosis stroke based on TOAST criteria
5. The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
7. fully understand and cooperate with the doctor's instructions.
8. the availability of informed consent;

Exclusion Criteria

1. Hemorrhagic stroke or mixed stroke
2. Combining with severe organ dysfunction
3. Past hemorrhagic stroke
4. A history of stroke with severe sequelae
5. Planning revascularization in 3 months
6. Ischemic stroke due to surgical intervention
7. participating in other clinical trials within 3 months
8. Pregnant or lactating women
9. any inappropriate patients assessed by the researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Head down position	head-down position treatment	head-down position treatment combined with conventional rehabilitation.
Conventional Rehabilitation	Conventional Rehabilitation	Conventional rehabilitation treatment
Head down position	Conventional Rehabilitation	head-down position treatment combined with conventional rehabilitation.

Primary Outcome Measures

Name	Time	Method
proportion of patients with modified Rankin Score 0 to 2	90 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 ShenYang, Liaoning, China