<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/NCT03283839</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01317-44</org_study_id>
    <nct_id>NCT03283839</nct_id>
  </id_info>
  <brief_title>Consequences of Temporomandibular Disorder on Balance Control</brief_title>
  <acronym>DAM</acronym>
  <official_title>Consequences of Temporomandibular Disorder on Balance Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on&#xD;
      postural control in somato-sensory and visual sensitization compared to control subjects&#xD;
      matched on age, sex and lifestyle.&#xD;
&#xD;
      Parameters will be estimated by measures realized before the therapeutic care of the TMD&#xD;
      (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control&#xD;
      subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control&#xD;
      in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its&#xD;
      therapeutic care on postural control in somato-sensory and visual sensitization compared to&#xD;
      control subjects matched on age, sex and lifestyle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Anticipated">June 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural control (before care for patients)</measure>
    <time_frame>At inclusion (before care for patients) (first evaluation)</time_frame>
    <description>Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural control (during care for patients)</measure>
    <time_frame>2 months after the first evaluation</time_frame>
    <description>Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural control (during care for patients)</measure>
    <time_frame>3 months after the first evaluation</time_frame>
    <description>Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural control (during care for patients)</measure>
    <time_frame>5 months after the first evaluation</time_frame>
    <description>Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance function</measure>
    <time_frame>T0 and 2,3 and 5 months after the first evaluation</time_frame>
    <description>Length and surface covered by the foot pressure center are measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orientation function</measure>
    <time_frame>T0 and 2,3 and 5 months after the first evaluation</time_frame>
    <description>Orientation is evaluated by the angle between the direction (of the gravity or of a part of his body) indicated by the subject and the real direction. It is evaluated with the road and frame test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>T0 and 2,3 and 5 months after the first evaluation</time_frame>
    <description>Visual Analog Scale (1 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tinnitus</measure>
    <time_frame>T0 and 2,3 and 5 months after the first evaluation</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <condition>Pathophysiology</condition>
  <condition>Therapy</condition>
  <arm_group>
    <arm_group_label>Temporomandibular disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Without temporomandibular disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Posturography</intervention_name>
    <description>Evaluation of postural control and of orientation function</description>
    <arm_group_label>Temporomandibular disorder</arm_group_label>
    <arm_group_label>Without temporomandibular disorder</arm_group_label>
    <other_name>Orientation perception</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient group: TMD patients, care: occlusal splint therapy, behavioral advices&#xD;
&#xD;
          -  Control group: matched with TMD patients (age, sex, lifestyle).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient group: treatment generating secondary effects in postural control (psychotrop,&#xD;
             antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma&#xD;
             (&lt; 4 months); vertigo and dysequilibrium (&lt; 6 months), whiplash&#xD;
&#xD;
          -  Control group: id. and TMD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philippe PERRIN</last_name>
    <phone>00 33 3 83 15 49 68</phone>
    <email>philippe.perrin@univ-lorraine.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nathalie PAOLI</last_name>
    <phone>00 33 3 83 15 49 68</phone>
    <email>nathalie.paoli@univ-lorraine.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU de NANCY</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathalie paoli</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>May 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Temporo-mandibular dysfunction</keyword>
  <keyword>Balance control</keyword>
  <keyword>Orientation function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</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/NCT03283839
org study id: 2016-A01317-44
nct id: NCT03283839
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on
      postural control in somato-sensory and visual sensitization compared to control subjects
      matched on age, sex and lifestyle.

      Parameters will be estimated by measures realized before the therapeutic care of the TMD
      (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control
      subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control
      in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.
Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its
      therapeutic care on postural control in somato-sensory and visual sensitization compared to
      control subjects matched on age, sex and lifestyle.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Postural control (before care for patients)
time frame: At inclusion (before care for patients) (first evaluation)
description: Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
measure: Postural control (during care for patients)
time frame: 2 months after the first evaluation
description: Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
measure: Postural control (during care for patients)
time frame: 3 months after the first evaluation
description: Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
measure: Postural control (during care for patients)
time frame: 5 months after the first evaluation
description: Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
measure: Balance function
time frame: T0 and 2,3 and 5 months after the first evaluation
description: Length and surface covered by the foot pressure center are measured
measure: Orientation function
time frame: T0 and 2,3 and 5 months after the first evaluation
description: Orientation is evaluated by the angle between the direction (of the gravity or of a part of his body) indicated by the subject and the real direction. It is evaluated with the road and frame test.
measure: Pain
time frame: T0 and 2,3 and 5 months after the first evaluation
description: Visual Analog Scale (1 to 10)
measure: Tinnitus
time frame: T0 and 2,3 and 5 months after the first evaluation
description: Questionnaire
arm group label: Temporomandibular disorder
arm group type: Other
arm group label: Without temporomandibular disorder
arm group type: Other
intervention type: Diagnostic Test
intervention name: Posturography
description: Evaluation of postural control and of orientation function
arm group label: Temporomandibular disorder
arm group label: Without temporomandibular disorder
other name: Orientation perception
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe PERRIN
phone: 00 33 3 83 15 49 68
email: philippe.perrin@univ-lorraine.fr
last name: Nathalie PAOLI
phone: 00 33 3 83 15 49 68
email: nathalie.paoli@univ-lorraine.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: No