Study Stopped
it is hard to enroll the patients
Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)
HOPES
1 other identifier
interventional
12
1 country
1
Brief Summary
The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedStudy Start
First participant enrolled
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedNovember 15, 2021
November 1, 2021
2.9 years
August 6, 2018
November 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients with modified Rankin Score 0 to 2
90 days
Secondary Outcomes (7)
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
90 days
The percentage of reduction in MMSE
90 days
The percentage of reduction in MoCA
90 days
- +2 more secondary outcomes
Study Arms (2)
Head down position
EXPERIMENTALhead-down position treatment combined with conventional rehabilitation.
Conventional Rehabilitation
SHAM COMPARATORConventional rehabilitation treatment
Interventions
In the head-down position, the body is in the supine position with the head lowered to 30 degrees
The body is in the supine position without lowered head
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of ShenYang Military Region
Shenyang, Liaoning, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui-Sheng Chen, doctor
General Hospital of Shenyang Military Region
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of neurological department
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 14, 2018
Study Start
August 6, 2018
Primary Completion
June 30, 2021
Study Completion
September 30, 2021
Last Updated
November 15, 2021
Record last verified: 2021-11