The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
real Acupuncture Needles
sham Acupuncture Needles
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
Patients with understanding dysfunction:
- Dysphasia, sensory aphasia,
- Patients with cerebral hemorrhage,
- pregnant women's, children's, and Patients with lack of judgment ability.
Sites / Locations
- Rambam Medical center, Neurology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1 real Acupuncture group-intervention
2 sham Acupuncture group
Arm Description
real Acupuncture Needles
sham Acupuncture Needles
Outcomes
Primary Outcome Measures
(NIHSS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02612441
First Posted
November 10, 2015
Last Updated
April 4, 2019
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02612441
Brief Title
The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
Official Title
The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
October 22, 2017 (Actual)
Study Completion Date
October 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
2. 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.
3. 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..
4. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 real Acupuncture group-intervention
Arm Type
Experimental
Arm Description
real Acupuncture Needles
Arm Title
2 sham Acupuncture group
Arm Type
Sham Comparator
Arm Description
sham Acupuncture Needles
Intervention Type
Device
Intervention Name(s)
real Acupuncture Needles
Intervention Description
Acupuncture needles
Intervention Type
Device
Intervention Name(s)
sham Acupuncture Needles
Intervention Description
sham Acupuncture Needles
Primary Outcome Measure Information:
Title
(NIHSS)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients with understanding dysfunction:
Dysphasia, sensory aphasia,
Patients with cerebral hemorrhage,
pregnant women's, children's, and Patients with lack of judgment ability.
Facility Information:
Facility Name
Rambam Medical center, Neurology Department
City
Haifa
Country
Israel
12. IPD Sharing Statement
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The Efficacy of Acupuncture on Patients With First Acute Ischemic Stroke, With Signs of Hemiplegia and Hemiparesis
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