Ischemic StrokeHOPESNCT03629652
Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)
A study testing head-down position treatment and Conventional Rehabilitation in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- head-down position treatment and Conventional Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Show all 9Show fewer
- participating in other clinical trials within 3 months
- Pregnant or lactating women
- any inappropriate patients assessed by the researcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
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.
- Conditions
- Ischemic Stroke
- Being tested
- head-down position treatment, Conventional Rehabilitation
- Keywords
- head-down position, ischemic stroke, rehabilitation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head-down position treatmentOther
In the head-down position, the body is in the supine position with the head lowered to 30 degrees
Conventional RehabilitationOther
The body is in the supine position without lowered head
| Study group | Role | What they receive |
|---|---|---|
| Head down position | Experimental | head-down position treatment combined with conventional rehabilitation. Receives: Other: head-down position treatment; Other: Conventional Rehabilitation |
| Conventional Rehabilitation | Sham comparator | Conventional rehabilitation treatment Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with modified Rankin Score 0 to 2
Measured: 90 days
Secondary outcomes (7)
proportion of patients with modified Rankin Score 0 to 1
Measured: 90 days
The percentage of reduction in Fugl-Meyer score
Measured: 90 days
occurrence of stroke
stroke or TIA
Measured: 90 days
The percentage of reduction in MMSE
MMSE，Mini-mental State Examination
Measured: 90 days
The percentage of reduction in MoCA
MoCA, Montreal Congnitive Assessment
Measured: 90 days
Incidence of major vascular events
ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death
Measured: 90 days
the biggest tolerance time of head-down
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start6 Aug 2018
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Why it stopped: it is hard to enroll the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Hui-Sheng Chen, doctor, Principal investigator, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629652
- Sponsor's protocol ID
- k(2018)25
- Acronym
- HOPES
- Status last verified
- Nov 2021
- First submitted
- 6 Aug 2018
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
- ClinicalTrials.gov ID
- NCT03629652
- Acronym / sponsor ID
- HOPES / k(2018)25
- Conditions
- Ischemic Stroke
- Keywords
- head-down position, ischemic stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it is hard to enroll the patients
- Enrolment
- 12 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head down position | Experimental | Other: head-down position treatment, Other: Conventional Rehabilitationhead-down position treatment combined with conventional rehabilitation. |
| Conventional Rehabilitation | Sham comparator | Other: Conventional RehabilitationConventional rehabilitation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head-down position treatmentIn the head-down position, the body is in the supine position with the head lowered to 30 degrees | Other | Head down position |
| Conventional RehabilitationThe body is in the supine position without lowered head | Other | Conventional Rehabilitation, Head down position |
Primary outcome
proportion of patients with modified Rankin Score 0 to 2
Time frame: 90 days
7 secondary outcomes
proportion of patients with modified Rankin Score 0 to 1
Time frame: 90 days
The percentage of reduction in Fugl-Meyer score
Time frame: 90 days
occurrence of stroke
Time frame: 90 days
The percentage of reduction in MMSE
Time frame: 90 days
The percentage of reduction in MoCA
Time frame: 90 days
Incidence of major vascular events
Time frame: 90 days
the biggest tolerance time of head-down
Time frame: 90 days
Results and safety
The study was stopped early (reason given: it is hard to enroll the patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Sheng Chen, doctor principal investigator
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head-down position treatment and Conventional Rehabilitation in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: it is hard to enroll the patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with modified Rankin Score 0 to 2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.