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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
Cathay General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Acupuncture therap, Acute stroke, Randomized controlled trials

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 14, 2014
    Last Updated
    February 6, 2023
    Sponsor
    Cathay General Hospital
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    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

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    Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients

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