<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/NCT02975362</url>
  </required_header>
  <id_info>
    <org_study_id>1640197030</org_study_id>
    <nct_id>NCT02975362</nct_id>
  </id_info>
  <brief_title>Acupuncture Treatment on Motor Dysfunction in Stroke Patients</brief_title>
  <official_title>Standardized Treatment of Acupuncture on Motor Dysfunction in Stroke Patients: a Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this proposed study is to determine whether acupuncture combined with&#xD;
      rehabilitation treatment could improve significantly motor function in ischemic stroke&#xD;
      patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of&#xD;
      acupuncture as additional treatment with the rehabilitation treatment, a total of 240&#xD;
      patients with stroke patients will be recruited. The patients will be randomly assigned to&#xD;
      acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n&#xD;
      =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured&#xD;
      using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time&#xD;
      are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are&#xD;
      measured using SS-QOL scale. The study will be conducted at Shanghai University of&#xD;
      Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional disorder is a common and serious consequence of stroke. A large proportion of&#xD;
      stroke patients develop motor dysfunction in the early stage after stroke. Acupuncture is&#xD;
      often used as an adjunct to mainstream rehabilitation after stroke. It has been widely&#xD;
      applied to be a kind of effective treatment for stroke in China. But, there is meta-analysis&#xD;
      suggests that with stroke rehabilitation, acupuncture has no additional effect on motor&#xD;
      recovery but has a small positive effect on disability, which may be due to a true placebo&#xD;
      effect and varied study quality. The efficacy of acupuncture without stroke rehabilitation&#xD;
      remains uncertain, mainly because of the poor quality of such studies.&#xD;
&#xD;
      The objective of this proposed study is to determine whether acupuncture combined with&#xD;
      rehabilitation treatment could improve significantly motor function in ischemic stroke&#xD;
      patients.&#xD;
&#xD;
      In this 8-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as&#xD;
      additional treatment with the rehabilitation treatment, a total of 240 patients with stroke&#xD;
      patients will be recruited. The patients will be randomly assigned to acupuncture combined&#xD;
      with rehabilitation treatment (n =120) or rehabilitation treatment (n =120). (40 sessions, 5&#xD;
      sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale&#xD;
      and Modified Barthel Index. Change in the stroke syndromes over time are measured using&#xD;
      stroke syndrome of TCM Scale. Change in the quality of life over time are measured using&#xD;
      SS-QOL scale.The study will be conducted at Shanghai University of Traditional Chinese&#xD;
      Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline FMA at 4 weeks, 8 weeks,6 months</measure>
    <time_frame>The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline SS-QOL at 4 weeks, 8 weeks,6 months</measure>
    <time_frame>The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).</time_frame>
    <description>The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure intended to provide an assessment of health-related quality of life, specific to patients with stroke. The SS-QOL questionnaire consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Scoring of the SS-QOL is rated on a 5-point Likert scale. Response options are scored as 5 (&quot;no help needed/no trouble at all/strongly disagree&quot;), 4 (&quot;a little help/a little trouble/moderately disagree&quot;), 3 (&quot;some help/some trouble/neither agree nor disagree&quot;), 2 (&quot;a lot of help/a lot of trouble/moderately agree&quot;), and 1 (&quot;total help/could not do it at all/strongly agree&quot;). The domains are scored separately, and a total score is also calculated, with higher scores indicating better function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline MBI at 4 weeks, 8 weeks,6 months</measure>
    <time_frame>The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).</time_frame>
    <description>The Barthel Index(BI) is a scale that measures ten basic aspects of activity daily living related to self-care and mobility. For the Chinese Modified Barthel Index(MBI) version, the ten items are: continence of bowels and bladder, feeding, dressing, transferring to and from a toilet, grooming, bathing, moving from wheelchair to bed and return, walking on level surface for 45 meters, and ascend and descend stairs. Standard for Evaluation：Each item (activity) be divided into 5 levels, different level represents a different degree of independence, the lowest level is 1 and the highest level is 5.The more higher level, more independence. The normal score is 100. If a person score is 100, he is able to get along without attendant care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline SSTCM at 4 weeks, 8 weeks,6 months</measure>
    <time_frame>The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).</time_frame>
    <description>The Stroke Syndrome of TCM (SSTCM) was developed mainly based on quantified index of TCM symptoms. The SSTCM includes signs and symptoms which were the most concern of the patients and doctors themselves after stroke. SSTCM mainly consists of two domains: TCM symptoms and pulse conditions and tongue pictures. TCM symptoms area contains 24 items. The assessment standards of each item was divided into four levels and corresponding scores (normal = 0, light = 1, middle=2, heavy = 3) according different degree base on the severity of the symptoms and the impacts on life. Pulse conditions and tongue pictures record contents only, not to score. The total score is calculated from the domain one, with lower scores indicating the lighter degree of the symptom severity and the less impact on life. The SSTCM was evaluated by experienced traditional Chinese medicine doctors who were accepted the unification of assessment training.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Stroke</condition>
  <condition>Motor Disorders</condition>
  <arm_group>
    <arm_group_label>Acupuncture combined rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture Treatment Rehabilitation Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rehabilitation Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture Treatment</intervention_name>
    <description>Acupuncture Treatment Acupoint selection base on disease stage combined adjunct acupuncture acupoint base on syndrome differentiation.①Base on disease stage: Flaccid paralysis period: DU24, DU20, Motor Area , LI15, LI14, LI11, SJ5, LI4, GB31, EX-LE2, GB34, ST36, ST40.Spastic period: DU24, DU20, Motor Area , SJ10, SJ13, LI10, SJ8, SJ5, SJ4, SJ4, BL37, BL40, BL39, BL55, BL57, ST41, GB40, BL60.②Base on syndrome differentiation:Excess syndrome of yang-type: LR3, ST37; Deficiency syndrome of Yang-type: KI3, BL23; Excess syndrome of yin-type: SP9, GB20;Deficiency syndrome of Yin-type: CV6, BL23.③Electroacupuncture acupoint: Flaccid paralysis period: LI15, LI4, GB31, ST40; Spastic period: SJ13, SJ5, BL40, BL57.30minutes each time,twenty times / treatment course，two treatment courses in total.</description>
    <arm_group_label>Acupuncture combined rehabilitation</arm_group_label>
    <other_name>Acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation Treatment</intervention_name>
    <description>Rehabilitation treatment The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists</description>
    <arm_group_label>Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The ages of stroke patients from 45 years old to 80 years old.&#xD;
&#xD;
          -  The principle diagnosis according to &lt;diagnosis-treatment criteria of stroke(trial&#xD;
             implementation)&gt;formulated by Collaboration Acute Brain Diseases of State&#xD;
             Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT&#xD;
             brain or MRI brain, with stable medical condition and awareness clear.&#xD;
&#xD;
          -  Recent stroke from 6month to 12 months after onset.&#xD;
&#xD;
          -  Stroke with limb motor dysfunction.&#xD;
&#xD;
          -  Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score&#xD;
             &gt; 24.&#xD;
&#xD;
          -  All the patients sign a consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke with conscious disturbance or serious cognitive impairment.&#xD;
&#xD;
          -  Presence of another chronic disorder, including severe Parkinson's disease, cardiac&#xD;
             disease, cancers, epilepsy, or chronic alcoholism.&#xD;
&#xD;
          -  Impaired hepatic or renal function&#xD;
&#xD;
          -  have bleeding tendency&#xD;
&#xD;
          -  Being oversensitive to acupuncture.&#xD;
&#xD;
          -  participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian Pei, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Longhua Hospital, Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>ShangHai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture Treatment; Motor Dysfunction; Stroke Patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Motor Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02975362
org study id: 1640197030
nct id: NCT02975362
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of this proposed study is to determine whether acupuncture combined with
      rehabilitation treatment could improve significantly motor function in ischemic stroke
      patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of
      acupuncture as additional treatment with the rehabilitation treatment, a total of 240
      patients with stroke patients will be recruited. The patients will be randomly assigned to
      acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n
      =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured
      using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time
      are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are
      measured using SS-QOL scale. The study will be conducted at Shanghai University of
      Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.
Functional disorder is a common and serious consequence of stroke. A large proportion of
      stroke patients develop motor dysfunction in the early stage after stroke. Acupuncture is
      often used as an adjunct to mainstream rehabilitation after stroke. It has been widely
      applied to be a kind of effective treatment for stroke in China. But, there is meta-analysis
      suggests that with stroke rehabilitation, acupuncture has no additional effect on motor
      recovery but has a small positive effect on disability, which may be due to a true placebo
      effect and varied study quality. The efficacy of acupuncture without stroke rehabilitation
      remains uncertain, mainly because of the poor quality of such studies.

      The objective of this proposed study is to determine whether acupuncture combined with
      rehabilitation treatment could improve significantly motor function in ischemic stroke
      patients.

      In this 8-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as
      additional treatment with the rehabilitation treatment, a total of 240 patients with stroke
      patients will be recruited. The patients will be randomly assigned to acupuncture combined
      with rehabilitation treatment (n =120) or rehabilitation treatment (n =120). (40 sessions, 5
      sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale
      and Modified Barthel Index. Change in the stroke syndromes over time are measured using
      stroke syndrome of TCM Scale. Change in the quality of life over time are measured using
      SS-QOL scale.The study will be conducted at Shanghai University of Traditional Chinese
      Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline FMA at 4 weeks, 8 weeks,6 months
time frame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
description: The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points
measure: Change from Baseline SS-QOL at 4 weeks, 8 weeks,6 months
time frame: The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
description: The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure intended to provide an assessment of health-related quality of life, specific to patients with stroke. The SS-QOL questionnaire consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Scoring of the SS-QOL is rated on a 5-point Likert scale. Response options are scored as 5 ("no help needed/no trouble at all/strongly disagree"), 4 ("a little help/a little trouble/moderately disagree"), 3 ("some help/some trouble/neither agree nor disagree"), 2 ("a lot of help/a lot of trouble/moderately agree"), and 1 ("total help/could not do it at all/strongly agree"). The domains are scored separately, and a total score is also calculated, with higher scores indicating better function.
measure: Change from Baseline MBI at 4 weeks, 8 weeks,6 months
time frame: The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
description: The Barthel Index(BI) is a scale that measures ten basic aspects of activity daily living related to self-care and mobility. For the Chinese Modified Barthel Index(MBI) version, the ten items are: continence of bowels and bladder, feeding, dressing, transferring to and from a toilet, grooming, bathing, moving from wheelchair to bed and return, walking on level surface for 45 meters, and ascend and descend stairs. Standard for Evaluation：Each item (activity) be divided into 5 levels, different level represents a different degree of independence, the lowest level is 1 and the highest level is 5.The more higher level, more independence. The normal score is 100. If a person score is 100, he is able to get along without attendant care.
measure: Change from Baseline SSTCM at 4 weeks, 8 weeks,6 months
time frame: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (6 months).
description: The Stroke Syndrome of TCM (SSTCM) was developed mainly based on quantified index of TCM symptoms. The SSTCM includes signs and symptoms which were the most concern of the patients and doctors themselves after stroke. SSTCM mainly consists of two domains: TCM symptoms and pulse conditions and tongue pictures. TCM symptoms area contains 24 items. The assessment standards of each item was divided into four levels and corresponding scores (normal = 0, light = 1, middle=2, heavy = 3) according different degree base on the severity of the symptoms and the impacts on life. Pulse conditions and tongue pictures record contents only, not to score. The total score is calculated from the domain one, with lower scores indicating the lighter degree of the symptom severity and the less impact on life. The SSTCM was evaluated by experienced traditional Chinese medicine doctors who were accepted the unification of assessment training.
arm group label: Acupuncture combined rehabilitation
arm group type: Experimental
description: Acupuncture Treatment Rehabilitation Treatment
arm group label: Rehabilitation
arm group type: Experimental
description: Rehabilitation Treatment
intervention type: Other
intervention name: Acupuncture Treatment
description: Acupuncture Treatment Acupoint selection base on disease stage combined adjunct acupuncture acupoint base on syndrome differentiation.①Base on disease stage: Flaccid paralysis period: DU24, DU20, Motor Area , LI15, LI14, LI11, SJ5, LI4, GB31, EX-LE2, GB34, ST36, ST40.Spastic period: DU24, DU20, Motor Area , SJ10, SJ13, LI10, SJ8, SJ5, SJ4, SJ4, BL37, BL40, BL39, BL55, BL57, ST41, GB40, BL60.②Base on syndrome differentiation:Excess syndrome of yang-type: LR3, ST37; Deficiency syndrome of Yang-type: KI3, BL23; Excess syndrome of yin-type: SP9, GB20;Deficiency syndrome of Yin-type: CV6, BL23.③Electroacupuncture acupoint: Flaccid paralysis period: LI15, LI4, GB31, ST40; Spastic period: SJ13, SJ5, BL40, BL57.30minutes each time,twenty times / treatment course，two treatment courses in total.
arm group label: Acupuncture combined rehabilitation
other name: Acupuncture
intervention type: Other
intervention name: Rehabilitation Treatment
description: Rehabilitation treatment The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists
arm group label: Rehabilitation
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jian Pei, MD
role: Study Chair
affiliation: Shanghai University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Stroke
mesh term: Motor Disorders
sharing ipd: Undecided