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/NCT06010940</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/002939</org_study_id>
      <nct_id>NCT06010940</nct_id>
    </id_info>
    <brief_title>Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients</brief_title>
    <official_title>Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the impact of physical therapy intervention of dysphagia on preventing&#xD;
        pneumonia in acute stroke patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thirty acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected&#xD;
        from the stroke unit in El-Kasr EL Ainy Hospital. Their ages ranged from 49 -65 years. Stroke&#xD;
        dysphagia was diagnosed by a neurologist. Gugging swallowing screen and A2DS2 score was used&#xD;
        to assess risk of developing pneumonia. Stroke associated pneumonia was diagnosed by:&#xD;
        Recommended Diagnostic Criteria for Definite and Probable SAP in Patients Not Receiving&#xD;
        Mechanical Ventilation Based on the CDC Criteria. The selected patients were randomly&#xD;
        assigned into two equal groups control group (A) and study group (B). Control group (A) was&#xD;
        treated by nasogastric tube and oral care. Study group (B) was treated as the control group&#xD;
        in addition to a designed physical therapy program consisting of neuromuscular electrical&#xD;
        stimulation in addition to exercises for oropharyngeal muscles. Assessment was done before&#xD;
        treatment, at the middle and at the end of treatment for each patient. Treatment was&#xD;
        conducted for five sessions per week for one month.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 11, 2020</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Gugging swallowing screen test score</measure>
      <time_frame>at baseline</time_frame>
      <description>Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Gugging swallowing screen test score</measure>
      <time_frame>post intervention (after one month)</time_frame>
      <description>Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Score (A2DS2)</measure>
      <time_frame>at baseline</time_frame>
      <description>It is a scale to detect risk of pneumonia. Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Score (A2DS2)</measure>
      <time_frame>post intervention (after one month)</time_frame>
      <description>It is a scale to detect risk of pneumonia.Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participant with stroke associated pneumonia</measure>
      <time_frame>at baseline</time_frame>
      <description>Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (&gt;38°C) , Leukopenia (&lt;4000 WBC/mm3), worsening cough...etc</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participant with stroke associated pneumonia</measure>
      <time_frame>At middle of intervention (after two weeks)</time_frame>
      <description>Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention crI,teria that include; Fever (&gt;38°C) , Leukopenia (&lt;4000 WBC/mm3), worsening cough...etc</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participant with stroke associated pneumonia</measure>
      <time_frame>post intervention (after one month)</time_frame>
      <description>Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (&gt;38°C) , Leukopenia (&lt;4000 WBC/mm3), worsening cough...etc</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Stroke, Acute</condition>
    <condition>Dysphagia</condition>
    <condition>Pneumonia</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control group (A) was treated by nasogastric tube and oral care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary supplement</intervention_name>
      <description>nasogastric tube and oral care</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical therapy</intervention_name>
      <description>Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients were diagnosed of stroke dysphagia by a neurologist.&#xD;
  &#xD;
            -  Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less&#xD;
               than or equal 16).&#xD;
  &#xD;
            -  Patients' age ranged from 49 to 65 years old.&#xD;
  &#xD;
            -  Patients had the ability to understand and follow instructions.&#xD;
  &#xD;
            -  Patients were able to sit in upright position.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of previous stroke.&#xD;
  &#xD;
            -  History of any swallowing problem.&#xD;
  &#xD;
            -  History of any disease, head and neck surgery or tumor that causes swallowing&#xD;
               dysfunction.&#xD;
  &#xD;
            -  Any lung disease or pneumonia on admission.&#xD;
  &#xD;
            -  Patients with cognitive deficits or disturbed conscious level.&#xD;
  &#xD;
            -  Patients on mechanical ventilator.&#xD;
  &#xD;
            -  Patients with sensory or global aphasia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>49 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Physical Therapy</name>
        <address>
          <city>Giza</city>
          <zip>11432</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.</citation>
      <PMID>34746431</PMID>
    </reference>
    <reference>
      <citation>Lo YK, Fu TC, Chen CP, Yuan SS, Hsu CC. Involvement of swallowing therapy is associated with improved long-term survival in patients with post-stroke dysphagia. Eur J Phys Rehabil Med. 2019 Dec;55(6):728-734. doi: 10.23736/S1973-9087.19.05893-3.</citation>
      <PMID>31958220</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>heba ahmed khalifa</investigator_full_name>
      <investigator_title>Ass. Prof. Dr of Physical therapy for Neurology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <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/NCT06010940
  org study id: P.T.REC/012/002939
  nct id: NCT06010940
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the impact of physical therapy intervention of dysphagia on preventing
        pneumonia in acute stroke patients
  Thirty acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected
        from the stroke unit in El-Kasr EL Ainy Hospital. Their ages ranged from 49 -65 years. Stroke
        dysphagia was diagnosed by a neurologist. Gugging swallowing screen and A2DS2 score was used
        to assess risk of developing pneumonia. Stroke associated pneumonia was diagnosed by:
        Recommended Diagnostic Criteria for Definite and Probable SAP in Patients Not Receiving
        Mechanical Ventilation Based on the CDC Criteria. The selected patients were randomly
        assigned into two equal groups control group (A) and study group (B). Control group (A) was
        treated by nasogastric tube and oral care. Study group (B) was treated as the control group
        in addition to a designed physical therapy program consisting of neuromuscular electrical
        stimulation in addition to exercises for oropharyngeal muscles. Assessment was done before
        treatment, at the middle and at the end of treatment for each patient. Treatment was
        conducted for five sessions per week for one month.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The Gugging swallowing screen test score
  time frame: at baseline
  description: Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
  measure: The Gugging swallowing screen test score
  time frame: post intervention (after one month)
  description: Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
  measure: Clinical Score (A2DS2)
  time frame: at baseline
  description: It is a scale to detect risk of pneumonia. Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
  measure: Clinical Score (A2DS2)
  time frame: post intervention (after one month)
  description: It is a scale to detect risk of pneumonia.Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
  measure: Number of participant with stroke associated pneumonia
  time frame: at baseline
  description: Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
  measure: Number of participant with stroke associated pneumonia
  time frame: At middle of intervention (after two weeks)
  description: Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention crI,teria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
  measure: Number of participant with stroke associated pneumonia
  time frame: post intervention (after one month)
  description: Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
  arm group label: control group
  arm group type: Active Comparator
  description: Control group (A) was treated by nasogastric tube and oral care.
  arm group label: study group
  arm group type: Experimental
  description: Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.
  intervention type: Dietary Supplement
  intervention name: Dietary supplement
  description: nasogastric tube and oral care
  arm group label: control group
  arm group label: study group
  intervention type: Other
  intervention name: Physical therapy
  description: Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.
  arm group label: study group
  criteria: 
  gender: All
  minimum age: 49 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  citation: Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
  PMID: 34746431
  citation: Lo YK, Fu TC, Chen CP, Yuan SS, Hsu CC. Involvement of swallowing therapy is associated with improved long-term survival in patients with post-stroke dysphagia. Eur J Phys Rehabil Med. 2019 Dec;55(6):728-734. doi: 10.23736/S1973-9087.19.05893-3.
  PMID: 31958220
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: heba ahmed khalifa
  investigator title: Ass. Prof. Dr of Physical therapy for Neurology
  mesh term: Pneumonia
  mesh term: Deglutition Disorders
  mesh term: Stroke
  sharing ipd: No