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TerminatedNCT03629652HOPESUpdated Nov 15, 2021

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

An interventional study of head-down position treatment and Conventional Rehabilitation in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-15.

Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment

Why this study was terminated
it is hard to enroll the patients
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • head-down position
  • ischemic stroke
  • rehabilitation
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 12 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Head down position

    head-down position treatment combined with conventional rehabilitation.

    Other: head-down position treatment · Other: Conventional Rehabilitation

  • Sham comparator
    Conventional Rehabilitation

    Conventional rehabilitation treatment

    Other: Conventional Rehabilitation

Interventions

  • Otherhead-down position treatment

    In the head-down position, the body is in the supine position with the head lowered to 30 degrees

  • OtherConventional Rehabilitation

    The body is in the supine position without lowered head

06

What researchers measure

Primary outcomes

  1. proportion of patients with modified Rankin Score 0 to 2

    Time frame: 90 days

Secondary outcomes

  1. proportion of patients with modified Rankin Score 0 to 1

    Time frame: 90 days

  2. The percentage of reduction in Fugl-Meyer score

    Time frame: 90 days

  3. occurrence of stroke

    stroke or TIA

    Time frame: 90 days

  4. The percentage of reduction in MMSE

    MMSE,Mini-mental State Examination

    Time frame: 90 days

  5. The percentage of reduction in MoCA

    MoCA, Montreal Congnitive Assessment

    Time frame: 90 days

  6. Incidence of major vascular events

    ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death

    Time frame: 90 days

  7. the biggest tolerance time of head-down

    Time frame: 90 days

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Study locations

1 site
  • General Hospital of ShenYang Military Region
    ShenYang, Liaoning, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03629652
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Director of neurological department, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Aug 14, 2018
Start date
Aug 6, 2018
Primary completion
Jun 30, 2021
Completion
Sep 30, 2021
Last update
Nov 15, 2021

Study contacts

Hui-Sheng Chen, doctor
principal investigator · General Hospital of Shenyang Military Region

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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