<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/NCT04486807</url>
  </required_header>
  <id_info>
    <org_study_id>BADEPAULE</org_study_id>
    <nct_id>NCT04486807</nct_id>
  </id_info>
  <brief_title>Shoulder Muscle Imbalance as a Risk Factor for Shoulder Injury in Elite Badminton Players</brief_title>
  <acronym>BADEPAULE</acronym>
  <official_title>Shoulder Muscle Imbalance as a Risk Factor for Shoulder Injury in Elite Adolescent Badminton Players: a Prospective Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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>
      Background: To assess the impact of pre-season clinical measures and rotator muscles strength&#xD;
      on the risk of significant shoulder injury (SSI) in elite badminton players Design:&#xD;
      Prospective cohort study Participants: Nineteen elite adolescents badminton players were&#xD;
      included and followed over the badminton season (from september 2018 to may 2019 and/or from&#xD;
      september 2019 to may 2020) .&#xD;
&#xD;
      Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder&#xD;
      strength testing. Clinical testing consisted in the shoulder range of motion (ROM)&#xD;
      measurements and the table-to-acromion distance (TAD)Isokinetic internal and external rotator&#xD;
      shoulder muscles strength was tested at 60 and 240°/s. Conventional and functional&#xD;
      (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an&#xD;
      experienced sport physician.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2018</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Baseline Isokinetic strength testing (peak torques)</measure>
    <time_frame>one preseason evaluation (september 2018 or september 2019)</time_frame>
    <description>Shoulder rotator muscles isokinetic strength test, Measures: Peak Torque on internal rotator muscles (IR) and external rotator muscles (ER), in NM (newton.meter)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Isokinetic strength testing (ratios)</measure>
    <time_frame>one preseason evaluation (september 2018 or september 2019)</time_frame>
    <description>Shoulder rotator muscles isokinetic strength test, Measures: ratios between external rotator muscles (ER) and internal rotator muscles (IR) (ER:IR), in percent (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical measurements, ROM</measure>
    <time_frame>ne evaluation, one preseason visit (september 2018 or september 2019)</time_frame>
    <description>Shoulder internal and external rotation range of motion (ROM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical measurements TAD</measure>
    <time_frame>one preseason visit (september 2018 or september 2019)</time_frame>
    <description>table-to-acromion distance (in cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Significant Shoulder Injury (SSI) collection (number of injury)</measure>
    <time_frame>During the badminton season, the number (number, n) of injury was recorded from september 2018 to may 2019 or from september 2019 to may 2020</time_frame>
    <description>Significant Shoulder Injury (SSI) collection for the number of injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Significant Shoulder Injury (SSI) collection (type of injury)</measure>
    <time_frame>During the badminton season, the type of injury (number, n) was recorded from september 2018 to may 2019 or from september 2019 to may 2020</time_frame>
    <description>Significant Shoulder Injury (SSI) collection for the type of injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Significant Shoulder Injury (SSI) collection (time lost from participation)</measure>
    <time_frame>During the badminton season, the time lost from participation was recorded (in days) from september 2018 to may 2019 or from september 2019 to may 2020</time_frame>
    <description>Significant Shoulder Injury (SSI) collection for time lost from participation due to the injury</description>
  </primary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Sport Injury</condition>
  <condition>Shoulder Injuries</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Elite badminton players</intervention_name>
    <description>The population was all the elite badminton players followed in a University Hospital Centre and the National Institute of Sport, Expertise, and Performance. We excluded players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery. They were included and followed during the badminton season (Nineteen elite badminton players and followed over the badminton season (from september 2018 to may 2019 or from september 2019 to may 2020)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Nineteen elite badminton players and followed over the badminton season (from september&#xD;
        2018 to may 2019 or from september 2019 to may 2020)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All the elite badminton players from a high-level club and the National Institute of Sport,&#xD;
        Expertise, and Performance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Caen Normandie</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Caen</investigator_affiliation>
    <investigator_full_name>Joffrey DRIGNY</investigator_full_name>
    <investigator_title>Principal Investigator, Chief Resident in the Sport Medicine Department (MD), PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Athletic Injuries</mesh_term>
    <mesh_term>Shoulder Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04486807
org study id: BADEPAULE
nct id: NCT04486807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: To assess the impact of pre-season clinical measures and rotator muscles strength
      on the risk of significant shoulder injury (SSI) in elite badminton players Design:
      Prospective cohort study Participants: Nineteen elite adolescents badminton players were
      included and followed over the badminton season (from september 2018 to may 2019 and/or from
      september 2019 to may 2020) .

      Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder
      strength testing. Clinical testing consisted in the shoulder range of motion (ROM)
      measurements and the table-to-acromion distance (TAD)Isokinetic internal and external rotator
      shoulder muscles strength was tested at 60 and 240°/s. Conventional and functional
      (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an
      experienced sport physician.
observational model: Cohort
time perspective: Prospective
measure: Baseline Isokinetic strength testing (peak torques)
time frame: one preseason evaluation (september 2018 or september 2019)
description: Shoulder rotator muscles isokinetic strength test, Measures: Peak Torque on internal rotator muscles (IR) and external rotator muscles (ER), in NM (newton.meter)
measure: Baseline Isokinetic strength testing (ratios)
time frame: one preseason evaluation (september 2018 or september 2019)
description: Shoulder rotator muscles isokinetic strength test, Measures: ratios between external rotator muscles (ER) and internal rotator muscles (IR) (ER:IR), in percent (%)
measure: Clinical measurements, ROM
time frame: ne evaluation, one preseason visit (september 2018 or september 2019)
description: Shoulder internal and external rotation range of motion (ROM)
measure: Clinical measurements TAD
time frame: one preseason visit (september 2018 or september 2019)
description: table-to-acromion distance (in cm)
measure: Significant Shoulder Injury (SSI) collection (number of injury)
time frame: During the badminton season, the number (number, n) of injury was recorded from september 2018 to may 2019 or from september 2019 to may 2020
description: Significant Shoulder Injury (SSI) collection for the number of injury
measure: Significant Shoulder Injury (SSI) collection (type of injury)
time frame: During the badminton season, the type of injury (number, n) was recorded from september 2018 to may 2019 or from september 2019 to may 2020
description: Significant Shoulder Injury (SSI) collection for the type of injury
measure: Significant Shoulder Injury (SSI) collection (time lost from participation)
time frame: During the badminton season, the time lost from participation was recorded (in days) from september 2018 to may 2019 or from september 2019 to may 2020
description: Significant Shoulder Injury (SSI) collection for time lost from participation due to the injury
intervention type: Diagnostic Test
intervention name: Elite badminton players
description: The population was all the elite badminton players followed in a University Hospital Centre and the National Institute of Sport, Expertise, and Performance. We excluded players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery. They were included and followed during the badminton season (Nineteen elite badminton players and followed over the badminton season (from september 2018 to may 2019 or from september 2019 to may 2020)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Caen
investigator full name: Joffrey DRIGNY
investigator title: Principal Investigator, Chief Resident in the Sport Medicine Department (MD), PhD student
mesh term: Wounds and Injuries
mesh term: Athletic Injuries
mesh term: Shoulder Injuries