<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/NCT03284125</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH3-RNI17/MATPF</org_study_id>
    <secondary_id>2017-A01577-46</secondary_id>
    <secondary_id>2017-39</secondary_id>
    <nct_id>NCT03284125</nct_id>
  </id_info>
  <brief_title>Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis</brief_title>
  <acronym>MATPF</acronym>
  <official_title>Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</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>
      The facial paralysis is a frequent disease causing important functionals swallowing&#xD;
      dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing&#xD;
      disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.&#xD;
&#xD;
      This prospective study has realised on the following of patients affected by facial paralysis&#xD;
      treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze&#xD;
      three components oh the oral phase of the swallowing ( drooling, mastication and handicap).&#xD;
      The evaluations was realized before the surgery and at 3 and 6 months after .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2017</start_date>
  <completion_date type="Actual">June 12, 2018</completion_date>
  <primary_completion_date type="Actual">June 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline lips pressure at 6 months</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drooling Severity and Frequency Scale (DSFS)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The Drooling Score equals the sum of the Severity and Frequency sub-scores. the severity sub scores contains five items ( 1= never, 2= mild drooling, 3= moderate drool, 4= severe drool, 5= profuse drool) The frequency sub score contains four items ( 1= no drooling, 2= occasionally, 3=frequently, 4= constant drooling)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual scale of food residue</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Patients must eat a melba toast on paretic side and after we evaluate the food residue before surgery and at 3 and 6 months after</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysphagia handicap index (DHI)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This self-administered questionnaire allows to evaluate 3 types of handicap (physical, functional and social) It contains 30 questions and the maximum score is 120 (0= never, 1= almost never, 2= occasionally, 3= almost always, 4= always)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Peripheral Facial Paralysis</condition>
  <arm_group>
    <arm_group_label>Facial paralysis</arm_group_label>
    <description>Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Swallowing disorders evaluation</intervention_name>
    <description>Self-administered questionnaires and non-invasive clinics tests</description>
    <arm_group_label>Facial paralysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients affected by facial paralysis and treated by lenthening temporalis myoplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic peripheral facial paralysis&#xD;
&#xD;
          -  Freyss score inferior at 15&#xD;
&#xD;
          -  Benefiting of a lengthening temporalis myoplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malformative syndrome&#xD;
&#xD;
          -  Other swallowing trouble&#xD;
&#xD;
          -  Psychiatric trouble&#xD;
&#xD;
          -  Opposed at this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris LAURE, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de chirurgie maxillo-faciale, CHRU de TOURS</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Facies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03284125
org study id: RIPH3-RNI17/MATPF
secondary id: 2017-A01577-46
secondary id: 2017-39
nct id: NCT03284125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The facial paralysis is a frequent disease causing important functionals swallowing
      dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing
      disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

      This prospective study has realised on the following of patients affected by facial paralysis
      treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze
      three components oh the oral phase of the swallowing ( drooling, mastication and handicap).
      The evaluations was realized before the surgery and at 3 and 6 months after .
observational model: Cohort
time perspective: Prospective
measure: Change from baseline lips pressure at 6 months
time frame: Baseline, 3 and 6 months
description: Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after
measure: Drooling Severity and Frequency Scale (DSFS)
time frame: Baseline, 3 and 6 months
description: The Drooling Score equals the sum of the Severity and Frequency sub-scores. the severity sub scores contains five items ( 1= never, 2= mild drooling, 3= moderate drool, 4= severe drool, 5= profuse drool) The frequency sub score contains four items ( 1= no drooling, 2= occasionally, 3=frequently, 4= constant drooling)
measure: Visual scale of food residue
time frame: Baseline, 3 and 6 months
description: Patients must eat a melba toast on paretic side and after we evaluate the food residue before surgery and at 3 and 6 months after
measure: Dysphagia handicap index (DHI)
time frame: Baseline, 3 and 6 months
description: This self-administered questionnaire allows to evaluate 3 types of handicap (physical, functional and social) It contains 30 questions and the maximum score is 120 (0= never, 1= almost never, 2= occasionally, 3= almost always, 4= always)
arm group label: Facial paralysis
description: Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.
intervention type: Other
intervention name: Swallowing disorders evaluation
description: Self-administered questionnaires and non-invasive clinics tests
arm group label: Facial paralysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Boris LAURE, MD-PhD
role: Principal Investigator
affiliation: University Hospital, Tours
facility: 
country: France
responsible party type: Sponsor
mesh term: Bell Palsy
mesh term: Deglutition Disorders
mesh term: Facial Paralysis
mesh term: Paralysis
mesh term: Facies
sharing ipd: No