StrokeNCT02612441
The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
A study testing real Acupuncture Needles in people with Stroke, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Chinese Acupuncture can improve the motor ability of patients after having first acute ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in minimum receiving number of 3 Acupuncture treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- real Acupuncture Needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to 22 Oct 2017
- 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
- All patients with first acute ischemic stroke, with preserved cognitive awareness and with the ability to sign on the research agreement forms.
- Division for two main groups:
- Group number 1: will get real Acupuncture
- Group number 2: will get false Acupuncture- ( SHAM).
- The patients will be selected with the assistance of statistical software which will divide them randomly and equally by the standard Criteria.
Who cannot join
- Patients with understanding dysfunction:
- Dysphasia, sensory aphasia,
- Patients with cerebral hemorrhage,
- pregnant women's, children's, and Patients with lack of judgment ability.
Trial locations and contacts
1 site in 1 country.
About this study
Chinese Acupuncture can improve the motor ability of patients after having first acute ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in minimum receiving number of 3 Acupuncture treatments.
The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first is the treatment when the stroke occurs, and the second is prevention from having more cerebral vascular accident in the future.
Read more
In the first accepted treatment line, the only medicinal measure that stand up in critique of organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited time after the CVA occur that it can be used. Also (TPA) can be used only on part of the patients with specific defined criterions.
The aim of this study is to add a new accepted treatment method that appointed to improve the results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is unambiguously.
Read the detailed description
The number of participant in the clinical trial: approximately 100 patients. 50 patients will receive Chinese Acupuncture and the others 50 will receive sham Acupuncture.
Stages and work method:
The treatments in Acupuncture will occur every week. Each patient will receive minimum 3 Acupuncture/ sham treatments while staying in the neurology department.
1 After the suitable patients selected to be included in the study, with the assistance of statistical software, the acupuncturist will get from each patient approval to be participating in the study.
- The direct physician of all the patients that will be participate in the study will approve the accepted treatment in Acupuncture/ sham and get the patients acceptance by signature.
- The acupuncturist will receive a list of all the patients after they signed the research agreement forms, and after they have been taking The National Institutes of Health Stroke Scale- (NIHSS) and Medical Research Council (MRC) Scale for Muscle Strength..
- The first treatment for each patient from each group (real or sham acupuncture), will take approximately 45 minutes and include:
- the acupuncturist will filling an intake form, according to the principle of Chinese medicine
- treatment: Staying with needles / sham needles for about 20 minutes. *take notice that the following treatments will take approximately 30 minutes and includes filling brief questions form according to the principle of Chinese medicine and treatment.
- Conditions
- Stroke
- Being tested
- real Acupuncture Needles, sham Acupuncture Needles
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real Acupuncture NeedlesDevice
Acupuncture needles
sham Acupuncture NeedlesDevice
sham Acupuncture Needles
| Study group | Role | What they receive |
|---|---|---|
| 1 real Acupuncture group-intervention | Experimental | real Acupuncture Needles Receives: Device: real Acupuncture Needles |
| 2 sham Acupuncture group | Sham comparator | sham Acupuncture Needles Receives: Device: sham Acupuncture Needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
(NIHSS)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion22 Oct 2017
- Study completion22 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612441
- Sponsor's protocol ID
- Acupuncture_neurology_CTIL
- Status last verified
- Apr 2019
- First submitted
- 10 Nov 2015
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
- ClinicalTrials.gov ID
- NCT02612441
- Acronym / sponsor ID
- Acupuncture_neurology_CTIL
- Conditions
- Stroke
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 22 Oct 2017 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
Chinese Acupuncture can improve the motor ability of patients after having first acute ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in minimum receiving number of 3 Acupuncture treatments.
The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first is the treatment when the stroke occurs, and the second is prevention from having more cerebral vascular accident in the future.
In the first accepted treatment line, the only medicinal measure that stand up in critique of organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited time after the CVA occur that it can be used. Also (TPA) can be used only on part of the patients with specific defined criterions.
The aim of this study is to add a new accepted treatment method that appointed to improve the results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is unambiguously.
Detailed description
The number of participant in the clinical trial: approximately 100 patients. 50 patients will receive Chinese Acupuncture and the others 50 will receive sham Acupuncture.
Stages and work method:
The treatments in Acupuncture will occur every week. Each patient will receive minimum 3 Acupuncture/ sham treatments while staying in the neurology department.
1 After the suitable patients selected to be included in the study, with the assistance of statistical software, the acupuncturist will get from each patient approval to be participating in the study.
- The direct physician of all the patients that will be participate in the study will approve the accepted treatment in Acupuncture/ sham and get the patients acceptance by signature.
- The acupuncturist will receive a list of all the patients after they signed the research agreement forms, and after they have been taking The National Institutes of Health Stroke Scale- (NIHSS) and Medical Research Council (MRC) Scale for Muscle Strength..
- The first treatment for each patient from each group (real or sham acupuncture), will take approximately 45 minutes and include:
- the acupuncturist will filling an intake form, according to the principle of Chinese medicine
- treatment: Staying with needles / sham needles for about 20 minutes. *take notice that the following treatments will take approximately 30 minutes and includes filling brief questions form according to the principle of Chinese medicine and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 real Acupuncture group-intervention | Experimental | Device: real Acupuncture Needlesreal Acupuncture Needles |
| 2 sham Acupuncture group | Sham comparator | Device: sham Acupuncture Needlessham Acupuncture Needles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients with first acute ischemic stroke, with preserved cognitive awareness and with the ability to sign on the research agreement forms.
- Group number 1: will get real Acupuncture
- Group number 2: will get false Acupuncture- ( SHAM).
Key exclusion criteria (4 listed)
- Patients with understanding dysfunction:
- pregnant women's, children's, and Patients with lack of judgment ability.
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 |
|---|---|---|
| real Acupuncture NeedlesAcupuncture needles | Device | 1 real Acupuncture group-intervention |
| sham Acupuncture Needlessham Acupuncture Needles | Device | 2 sham Acupuncture group |
Primary outcome
(NIHSS)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real Acupuncture Needles in people with Stroke, run by Rambam Health Care Campus at 1 site in Israel.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 Apr 2019. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
(NIHSS) (time frame: 1 week). 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 8 Apr 2019.