xml: <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/NCT05982977</url>
    </required_header>
    <id_info>
      <org_study_id>2022J01880</org_study_id>
      <nct_id>NCT05982977</nct_id>
    </id_info>
    <brief_title>Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke</brief_title>
    <official_title>Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qingqing Zhang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fujian University of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fujian University of Traditional Chinese Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral&#xD;
        dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of&#xD;
        swallowing that is completely discretionary. Swallowing activity in the oral stage is not&#xD;
        only related to the formation and push of food pellets, but also affects the continuity&#xD;
        between the transition from spontaneous swallowing to the swallowing reflex.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After stroke, patients are prone to oral dysphagia, poor control of food masses and liquids&#xD;
        in the mouth, resulting in food spillover, residual and premature overflow, resulting in&#xD;
        dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which&#xD;
        greatly reduce the eating safety and quality of life of patients after stroke. Therefore, the&#xD;
        rehabilitation of oral swallowing function is a way for patients with swallowing disorder&#xD;
        after stroke to return to society and improve their quality of life. Previous studies have&#xD;
        found that acupuncture is an effective intervention to improve swallowing disorder in oral&#xD;
        stage after stroke. Whether acupuncture promotes the improvement of swallowing function in&#xD;
        oral stage by regulating the synergic activity of cortical swallowing network and muscle&#xD;
        group has not been fully clarified.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>
      <intervention_model_description>This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Since acupuncture intervention could not blind subjects and investigators, evaluators and statisticians were secretly grouped to avoid measurement bias as much as possible</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Oral functional score</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>To assess participants' oral swallowing function</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surface electromyography</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>To assess the swallowing muscle activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Water swallowing test (WST)</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>The severity of dysphagia was assessed by the WST. Level 1: Can drink 30ml water successfully within 5 seconds; Level 2: Drink water more than 2 times, can swallow without choking. Level 3: Can be drunk once, but cough. Level 4: swallowed more than twice, but with choking. Level 5: Frequent choking, unable to swallow all. Normal: Level 1, Suspicious: Level 1, more than 5 seconds or level 2; Abnormal: Level 3 to 5</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Standardized Swallowing Assessment (SSA)</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>To assess the severity of swallowing. The lowest score on this scale is 18 points, the highest score is 46 points, the higher the score, the worse the swallowing function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Oral Intake Scale (FOIS)</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>To assess the condition of swallowing. The grade of FOIS was categorized as level 1 to 3 (poor FOIS: tube feeding), levels 4 and 5 (moderate FOIS: total oral diet requiring special preparation) or levels 6 and 7 (good FOIS: total oral diet without special preparation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Teacher salivation rating (TDS)</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>Assess salivation. Level 1: No salivation; Level 2: Small amount, occasional flow. Level 3: Stream from time to time; Level 4: Flow frequently, but not linearly; Level 5: Flow in line, chest often wet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Swallowing Related Daily Quality of Life Scale (SWAL-QOL)</measure>
      <time_frame>4 weeks (Before and after intervation)</time_frame>
      <description>Assessed patients' quality of life. The SWAL-QOL scale consists of 11 dimensions, covering 44 items, of which 10 dimensions measure patients' quality of life and one dimension measures patients' swallowing symptoms. The 10 quality of life dimensions included 30 items, of which 8 (25 items in total) were related to swallowing, including psychological burden, eating time, appetite, food choice, verbal communication, fear of eating, mental health, and social interaction: the common dimension had 2 (5 items in total), including fatigue and sleep. The dimension of swallowing symptoms included 14 items. The SWAL-OOL scale was scored by Likert scoring method. The higher the score of five levels (1-5 respectively), the better the quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Dysphagia</condition>
    <condition>Stroke</condition>
    <condition>Oral Phase</condition>
    <arm_group>
      <arm_group_label>Acupuncture rehabilitation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Acupuncture rehabilitation intervention was given on the basis of conventional rehabilitation therapy.Disinfected with 75% alcohol and applied the needles at a depth of 25-35mm. Acupuncture stimulation of Lianquan (CV23) and Fengchi (GB20). The needles were retained for 30 minutes/time, once a day, and 5 days/week for a total of 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional rehabilitation group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group participants would take swallowing training 30 minutes/time, once a day, 5 days/week, a total of 4 weeks of intervention. At the same time, stroke basic treatment, nutritional support and other symptomatic treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.</description>
      <arm_group_label>Acupuncture rehabilitation group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Conventional rehabilitation</intervention_name>
      <description>swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.</description>
      <arm_group_label>Conventional rehabilitation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients meeting the diagnostic criteria for acute ischemic stroke established by the&#xD;
               Neurology Society of the Chinese Medical Association and confirmed by craniocerebral&#xD;
               CT or MRI;&#xD;
  &#xD;
            2. Oral dysphagia caused by stroke;&#xD;
  &#xD;
            3. Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;&#xD;
  &#xD;
            4. MoCA score of 21 or above, able to understand and follow simple instructions from the&#xD;
               treatment staff, able to cooperate and willing to undergo examination and treatment;&#xD;
  &#xD;
            5. 40 to 75 years old;&#xD;
  &#xD;
            6. Conscious and stable vital signs;&#xD;
  &#xD;
            7. Convalescent patients with stroke course and dysphagia duration between 1-6 months;&#xD;
  &#xD;
            8. Voluntary participation and informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with dysphagia not caused by stroke or non-stroke oral dysphagia;&#xD;
  &#xD;
            2. Previous history of stroke or dysphagia;&#xD;
  &#xD;
            3. Patients with serious primary diseases or mental disorders of other systems;&#xD;
  &#xD;
            4. Suffering from various bleeding prone diseases;&#xD;
  &#xD;
            5. Severe needle fainting;&#xD;
  &#xD;
            6. People with metal implants.&#xD;
  &#xD;
            7. Patients with poor compliance are not treated as prescribed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qingqing Zhang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian University of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qingqing Zhang</last_name>
      <phone>18150019719</phone>
      <email>2017013@fjtcm.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fujian University of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>Qingqing Zhang</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Dysphagia</keyword>
    <keyword>stroke</keyword>
    <keyword>cortical swallowing network</keyword>
    <keyword>Oral Phase</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982977
  org study id: 2022J01880
  nct id: NCT05982977
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral
        dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of
        swallowing that is completely discretionary. Swallowing activity in the oral stage is not
        only related to the formation and push of food pellets, but also affects the continuity
        between the transition from spontaneous swallowing to the swallowing reflex.
  After stroke, patients are prone to oral dysphagia, poor control of food masses and liquids
        in the mouth, resulting in food spillover, residual and premature overflow, resulting in
        dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which
        greatly reduce the eating safety and quality of life of patients after stroke. Therefore, the
        rehabilitation of oral swallowing function is a way for patients with swallowing disorder
        after stroke to return to society and improve their quality of life. Previous studies have
        found that acupuncture is an effective intervention to improve swallowing disorder in oral
        stage after stroke. Whether acupuncture promotes the improvement of swallowing function in
        oral stage by regulating the synergic activity of cortical swallowing network and muscle
        group has not been fully clarified.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Since acupuncture intervention could not blind subjects and investigators, evaluators and statisticians were secretly grouped to avoid measurement bias as much as possible
  measure: Oral functional score
  time frame: 4 weeks (Before and after intervation)
  description: To assess participants' oral swallowing function
  measure: Surface electromyography
  time frame: 4 weeks (Before and after intervation)
  description: To assess the swallowing muscle activity
  measure: Water swallowing test (WST)
  time frame: 4 weeks (Before and after intervation)
  description: The severity of dysphagia was assessed by the WST. Level 1: Can drink 30ml water successfully within 5 seconds; Level 2: Drink water more than 2 times, can swallow without choking. Level 3: Can be drunk once, but cough. Level 4: swallowed more than twice, but with choking. Level 5: Frequent choking, unable to swallow all. Normal: Level 1, Suspicious: Level 1, more than 5 seconds or level 2; Abnormal: Level 3 to 5
  measure: Standardized Swallowing Assessment (SSA)
  time frame: 4 weeks (Before and after intervation)
  description: To assess the severity of swallowing. The lowest score on this scale is 18 points, the highest score is 46 points, the higher the score, the worse the swallowing function.
  measure: Functional Oral Intake Scale (FOIS)
  time frame: 4 weeks (Before and after intervation)
  description: To assess the condition of swallowing. The grade of FOIS was categorized as level 1 to 3 (poor FOIS: tube feeding), levels 4 and 5 (moderate FOIS: total oral diet requiring special preparation) or levels 6 and 7 (good FOIS: total oral diet without special preparation).
  measure: Teacher salivation rating (TDS)
  time frame: 4 weeks (Before and after intervation)
  description: Assess salivation. Level 1: No salivation; Level 2: Small amount, occasional flow. Level 3: Stream from time to time; Level 4: Flow frequently, but not linearly; Level 5: Flow in line, chest often wet
  measure: Swallowing Related Daily Quality of Life Scale (SWAL-QOL)
  time frame: 4 weeks (Before and after intervation)
  description: Assessed patients' quality of life. The SWAL-QOL scale consists of 11 dimensions, covering 44 items, of which 10 dimensions measure patients' quality of life and one dimension measures patients' swallowing symptoms. The 10 quality of life dimensions included 30 items, of which 8 (25 items in total) were related to swallowing, including psychological burden, eating time, appetite, food choice, verbal communication, fear of eating, mental health, and social interaction: the common dimension had 2 (5 items in total), including fatigue and sleep. The dimension of swallowing symptoms included 14 items. The SWAL-OOL scale was scored by Likert scoring method. The higher the score of five levels (1-5 respectively), the better the quality of life.
  arm group label: Acupuncture rehabilitation group
  arm group type: Experimental
  description: Acupuncture rehabilitation intervention was given on the basis of conventional rehabilitation therapy.Disinfected with 75% alcohol and applied the needles at a depth of 25-35mm. Acupuncture stimulation of Lianquan (CV23) and Fengchi (GB20). The needles were retained for 30 minutes/time, once a day, and 5 days/week for a total of 4 weeks.
  arm group label: Conventional rehabilitation group
  arm group type: Active Comparator
  description: This group participants would take swallowing training 30 minutes/time, once a day, 5 days/week, a total of 4 weeks of intervention. At the same time, stroke basic treatment, nutritional support and other symptomatic treatment
  intervention type: Other
  intervention name: Acupuncture
  description: The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.
  arm group label: Acupuncture rehabilitation group
  intervention type: Behavioral
  intervention name: Conventional rehabilitation
  description: swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.
  arm group label: Conventional rehabilitation group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Qingqing Zhang
  role: Principal Investigator
  affiliation: Fujian University of Traditional Chinese Medicine
  last name: Qingqing Zhang
  phone: 18150019719
  email: 2017013@fjtcm.edu.cn
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fujian University of Traditional Chinese Medicine
  investigator full name: Qingqing Zhang
  investigator title: Lecturer
  mesh term: Deglutition Disorders
  mesh term: Stroke
  sharing ipd: No