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

G

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Terminated

Conditions

Ischemic Stroke

Treatments

Other: Conventional Rehabilitation
Other: head-down position treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03629652
k(2018)25

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

Head down position
Experimental group
Description:
head-down position treatment combined with conventional rehabilitation.
Treatment:
Other: head-down position treatment
Other: Conventional Rehabilitation
Conventional Rehabilitation
Sham Comparator group
Description:
Conventional rehabilitation treatment
Treatment:
Other: Conventional Rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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