<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/NCT02197663</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH102-REC2-015</org_study_id>
    <nct_id>NCT02197663</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident</brief_title>
  <official_title>Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The lifestyle of Taiwanese people has been changed over the past decade with the improvement&#xD;
      of economic growth, environmental sanitation and the quality of medical care. Now the&#xD;
      investigators pay more attention to the increasing risk of people's diseases of civilization&#xD;
      than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular&#xD;
      accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the&#xD;
      patient of cerebrovascular accident cause a lot of money and is a burden of our country.&#xD;
&#xD;
      Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with&#xD;
      cerebrovascular accident. The investigators use some scales to assess efficacy of&#xD;
      acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual&#xD;
      Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.&#xD;
&#xD;
      Besides, the investigators notice that there are few journals about acupuncture effect of&#xD;
      treating depression following cerebral vascular accident. The investigators may underestimate&#xD;
      the amount of people having post-stroke depression. So the investigators use Hamilton&#xD;
      Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident&#xD;
      patient.&#xD;
&#xD;
      By assessing bio-psycho-social level of CVA patient, the investigators hope this study will&#xD;
      offer them more &quot;Holistic Health Care&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We want to assess the effect of acupuncture on stroke patients. The study is a double-blind&#xD;
      randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:&#xD;
&#xD;
      (1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      (1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple&#xD;
      organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months).&#xD;
      The acupoints are fixed and located over head and limbs.&#xD;
&#xD;
      The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are&#xD;
      fixed and 1cm away from meridian and no acupoints over head were chosen.&#xD;
&#xD;
      The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton&#xD;
      Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue&#xD;
      Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as&#xD;
      below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last&#xD;
      time of treatment). The course of treatment should be completed within 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    the numbers of drop-out patients are more than we anticipate&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Barthel index at 8 weeks</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Barthel Index at 16 weeks</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Barthel Index at 24 weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in National Institute of Health Stroke Scale at 8 weeks</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in National Institute of Health Stroke Scale at 16 weeks</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in National Institute of Health Stroke Scale at 24 weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Hamilton Depression Rating Scale at 8 weeks</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Hamilton Depression Rating Scale at 16 weeks</measure>
    <time_frame>Baseline,16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Hamilton Depression Rating Scale at 24 weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Visual Analogue Scale at 8 weeks</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Visual Analogue Scale at 16 weeks</measure>
    <time_frame>Baseline,16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Visual Analogue Scale at 24 weeks</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture(44mm in length and 32-gauge)</intervention_name>
    <description>The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.&#xD;
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>sham acupuncture</arm_group_label>
    <other_name>acupuncture(4.4cm in length and 32-gauge)</other_name>
    <other_name>shame acupuncture(1.27 cm in length and 40-gauge)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  transient ischemic attack&#xD;
&#xD;
          -  brain tumor, brain trauma&#xD;
&#xD;
          -  recurrent stroke&#xD;
&#xD;
          -  multiple organs failure, cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Chen Lee, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Acupuncture, China Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Acupuncture, China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>October 20, 2015</last_update_submitted>
  <last_update_submitted_qc>October 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>stroke</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02197663
org study id: CMUH102-REC2-015
nct id: NCT02197663
lead sponsor: 
has dmc: No
The lifestyle of Taiwanese people has been changed over the past decade with the improvement
      of economic growth, environmental sanitation and the quality of medical care. Now the
      investigators pay more attention to the increasing risk of people's diseases of civilization
      than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular
      accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the
      patient of cerebrovascular accident cause a lot of money and is a burden of our country.

      Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with
      cerebrovascular accident. The investigators use some scales to assess efficacy of
      acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual
      Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.

      Besides, the investigators notice that there are few journals about acupuncture effect of
      treating depression following cerebral vascular accident. The investigators may underestimate
      the amount of people having post-stroke depression. So the investigators use Hamilton
      Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident
      patient.

      By assessing bio-psycho-social level of CVA patient, the investigators hope this study will
      offer them more "Holistic Health Care".
We want to assess the effect of acupuncture on stroke patients. The study is a double-blind
      randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:

      (1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

      Exclusion Criteria:

      (1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple
      organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months).
      The acupoints are fixed and located over head and limbs.

      The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are
      fixed and 1cm away from meridian and no acupoints over head were chosen.

      The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton
      Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue
      Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as
      below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last
      time of treatment). The course of treatment should be completed within 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in Barthel index at 8 weeks
time frame: Baseline and 8 weeks
measure: Change from baseline in Barthel Index at 16 weeks
time frame: Baseline, 16 weeks
measure: Change from baseline in Barthel Index at 24 weeks
time frame: Baseline, 24 weeks
measure: Change from baseline in National Institute of Health Stroke Scale at 8 weeks
time frame: Baseline, 8 weeks
measure: Change from baseline in National Institute of Health Stroke Scale at 16 weeks
time frame: Baseline, 16 weeks
measure: Change from baseline in National Institute of Health Stroke Scale at 24 weeks
time frame: Baseline, 24 weeks
measure: Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
time frame: Baseline, 8 weeks
measure: Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
time frame: Baseline, 16 weeks
measure: Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
time frame: Baseline, 24 weeks
measure: Change from baseline in Hamilton Depression Rating Scale at 8 weeks
time frame: Baseline, 8 weeks
measure: Change from baseline in Hamilton Depression Rating Scale at 16 weeks
time frame: Baseline,16 weeks
measure: Change from baseline in Hamilton Depression Rating Scale at 24 weeks
time frame: Baseline, 24 weeks
measure: Change from baseline in Visual Analogue Scale at 8 weeks
time frame: Baseline, 8 weeks
measure: Change from baseline in Visual Analogue Scale at 16 weeks
time frame: Baseline,16 weeks
measure: Change from baseline in Visual Analogue Scale at 24 weeks
time frame: Baseline, 24 weeks
arm group label: Acupuncture
arm group type: Experimental
description: The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
arm group label: sham acupuncture
arm group type: Sham Comparator
description: The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
intervention type: Procedure
intervention name: acupuncture(44mm in length and 32-gauge)
description: The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
arm group label: Acupuncture
arm group label: sham acupuncture
other name: acupuncture(4.4cm in length and 32-gauge)
other name: shame acupuncture(1.27 cm in length and 40-gauge)
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Chen Lee, PHD
role: Study Director
affiliation: Department of Acupuncture, China Medical University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke