Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Primary Purpose
Acute Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring Acupuncture therap, Acute stroke, Randomized controlled trials
Eligibility Criteria
Inclusion Criteria:
- newly onset of acute ischemic stroke,Exclusion Criteria:
- without underling systemic major illness
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acupuncture
Arm Description
The acupuncture treatment for the intervention group was provided once daily for 2 weeks.
Outcomes
Primary Outcome Measures
National Institute of Health Stroke Scale
Fugal-Mayer Assessment
Functional Independent Measure
Secondary Outcome Measures
National Institute of Health Stroke Scale
Barthel index
Modified Rankin Scale
Full Information
NCT ID
NCT02210988
First Posted
July 14, 2014
Last Updated
February 6, 2023
Sponsor
Cathay General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02210988
Brief Title
Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Official Title
Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cathay General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients:
Detailed Description
Acupuncture therapy in traditional Chinese medicine has been verified in many disease by thousands years. Due to the feasible and relatively safe in acupuncture management, now the west countries had been well document about acupuncture in medicine. The acupuncture therapy applied in post stroke functional recovery has been considered as more benefit than physical therapy only to post stroke rehabilitation. However, the effect of combined acupuncture therapy with standard management in acute stroke patient still remains unknown. The aim of this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients. The prospective study was designed as a randomized, single blinded, control trial. We collected newly onset of acute ischemic stroke patient without underling systemic major illness, and randomized assign the collected patients into two groups as experimental (acupuncture)group and normal control group. The two groups both treat with routine western medicine as standard stroke therapy. The outcome measurement will evaluate by the changes from baseline at one and three months. The assessed scales including NIH stroke scale, the Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the Modified Rankin Scale. We compared the all variable measurements to see if any benefit from acupuncture group than the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Acupuncture therap, Acute stroke, Randomized controlled trials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture
Arm Type
Experimental
Arm Description
The acupuncture treatment for the intervention group was provided once daily for 2 weeks.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Intervention with acupuncture
Primary Outcome Measure Information:
Title
National Institute of Health Stroke Scale
Time Frame
the fourth week
Title
Fugal-Mayer Assessment
Time Frame
The fourth week
Title
Functional Independent Measure
Time Frame
The fourth week
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale
Time Frame
The three months after admission
Title
Barthel index
Time Frame
The three month after admission
Title
Modified Rankin Scale
Time Frame
The three after admission
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events
Description
Adverse events was monitored in each acupuncture maneuver and post therapeutic course two weeks later.
Time Frame
The two week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly onset of acute ischemic stroke,Exclusion Criteria:
without underling systemic major illness
12. IPD Sharing Statement
Citations:
PubMed Identifier
27095698
Citation
Liu CH, Hsieh YT, Tseng HP, Lin HC, Lin CL, Wu TY, Lin SH, Tsao SH, Zhang H. Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study. Acupunct Med. 2016 Oct;34(5):349-355. doi: 10.1136/acupmed-2015-010825. Epub 2016 Apr 19.
Results Reference
derived
Learn more about this trial
Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
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