search
Back to results

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

Primary Purpose

Ischemic Stroke

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
head-down position treatment
Conventional Rehabilitation
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring head-down position, ischemic stroke, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of ShenYang Military Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Head down position

Conventional Rehabilitation

Arm Description

head-down position treatment combined with conventional rehabilitation.

Conventional rehabilitation treatment

Outcomes

Primary Outcome Measures

proportion of patients with modified Rankin Score 0 to 2

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2018
Last Updated
November 7, 2021
Sponsor
General Hospital of Shenyang Military Region
search

1. Study Identification

Unique Protocol Identification Number
NCT03629652
Brief Title
Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)
Acronym
HOPES
Official Title
Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
it is hard to enroll the patients
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
head-down position, ischemic stroke, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Head down position
Arm Type
Experimental
Arm Description
head-down position treatment combined with conventional rehabilitation.
Arm Title
Conventional Rehabilitation
Arm Type
Sham Comparator
Arm Description
Conventional rehabilitation treatment
Intervention Type
Other
Intervention Name(s)
head-down position treatment
Intervention Description
In the head-down position, the body is in the supine position with the head lowered to 30 degrees
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
The body is in the supine position without lowered head
Primary Outcome Measure Information:
Title
proportion of patients with modified Rankin Score 0 to 2
Time Frame
90 days
Secondary Outcome Measure Information:
Title
proportion of patients with modified Rankin Score 0 to 1
Time Frame
90 days
Title
The percentage of reduction in Fugl-Meyer score
Time Frame
90 days
Title
occurrence of stroke
Description
stroke or TIA
Time Frame
90 days
Title
The percentage of reduction in MMSE
Description
MMSE，Mini-mental State Examination
Time Frame
90 days
Title
The percentage of reduction in MoCA
Description
MoCA, Montreal Congnitive Assessment
Time Frame
90 days
Title
Incidence of major vascular events
Description
ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death
Time Frame
90 days
Title
the biggest tolerance time of head-down
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, doctor
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of ShenYang Military Region
City
ShenYang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs