<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210988</url>
  </required_header>
  <id_info>
    <org_study_id>CGHIRBCT-P-100002</org_study_id>
    <nct_id>NCT02210988</nct_id>
  </id_info>
  <brief_title>Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients</brief_title>
  <official_title>Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cathay General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cathay General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators design a randomized, single blinded, control study to evaluate the&#xD;
      therapeutic effect of acupuncture in acute ischemic stroke patients:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acupuncture therapy in traditional Chinese medicine has been verified in many disease by&#xD;
      thousands years. Due to the feasible and relatively safe in acupuncture management, now the&#xD;
      west countries had been well document about acupuncture in medicine. The acupuncture therapy&#xD;
      applied in post stroke functional recovery has been considered as more benefit than physical&#xD;
      therapy only to post stroke rehabilitation. However, the effect of combined acupuncture&#xD;
      therapy with standard management in acute stroke patient still remains unknown. The aim of&#xD;
      this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke&#xD;
      patients. The prospective study was designed as a randomized, single blinded, control trial.&#xD;
      We collected newly onset of acute ischemic stroke patient without underling systemic major&#xD;
      illness, and randomized assign the collected patients into two groups as experimental&#xD;
      (acupuncture)group and normal control group. The two groups both treat with routine western&#xD;
      medicine as standard stroke therapy. The outcome measurement will evaluate by the changes&#xD;
      from baseline at one and three months. The assessed scales including NIH stroke scale, the&#xD;
      Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the&#xD;
      Modified Rankin Scale. We compared the all variable measurements to see if any benefit from&#xD;
      acupuncture group than the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>National Institute of Health Stroke Scale</measure>
    <time_frame>the fourth week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugal-Mayer Assessment</measure>
    <time_frame>The fourth week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Independent Measure</measure>
    <time_frame>The fourth week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale</measure>
    <time_frame>The three months after admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel index</measure>
    <time_frame>The three month after admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>The three after admission</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>The two week</time_frame>
    <description>Adverse events was monitored in each acupuncture maneuver and post therapeutic course two weeks later.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Acute Stroke</condition>
  <arm_group>
    <arm_group_label>acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The acupuncture treatment for the intervention group was provided once daily for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Intervention with acupuncture</description>
    <arm_group_label>acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly onset of acute ischemic stroke,Exclusion Criteria:&#xD;
&#xD;
          -  without underling systemic major illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture therap</keyword>
  <keyword>Acute stroke</keyword>
  <keyword>Randomized controlled trials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210988
org study id: CGHIRBCT-P-100002
nct id: NCT02210988
lead sponsor: 
has dmc: Yes
The investigators design a randomized, single blinded, control study to evaluate the
      therapeutic effect of acupuncture in acute ischemic stroke patients:
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: National Institute of Health Stroke Scale
time frame: the fourth week
measure: Fugal-Mayer Assessment
time frame: The fourth week
measure: Functional Independent Measure
time frame: The fourth week
measure: National Institute of Health Stroke Scale
time frame: The three months after admission
measure: Barthel index
time frame: The three month after admission
measure: Modified Rankin Scale
time frame: The three after admission
measure: Number of Participants with Adverse Events
time frame: The two week
description: Adverse events was monitored in each acupuncture maneuver and post therapeutic course two weeks later.
arm group label: acupuncture
arm group type: Experimental
description: The acupuncture treatment for the intervention group was provided once daily for 2 weeks.
intervention type: Other
intervention name: acupuncture
description: Intervention with acupuncture
arm group label: acupuncture
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke