<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/NCT03797430</url>
  </required_header>
  <id_info>
    <org_study_id>SEBTHAND ( 29BRC18.0254)</org_study_id>
    <nct_id>NCT03797430</nct_id>
  </id_info>
  <brief_title>Determination of Normal Values for the Star Excursion Balance Test (SEBT) in Handball Players</brief_title>
  <acronym>SEBTHAND</acronym>
  <official_title>Determination of Normal Values for the Star Excursion Balance Test(SEBT) in National or International Handball Young Women Players</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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 aim of this study is to determine normal values for SEBT in young national or&#xD;
      international handball women players for determining specific level for SEBT to predict risk&#xD;
      of injury&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    NO PARTICIPANTS ENROLLED&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2, 2019</start_date>
  <completion_date type="Anticipated">January 2, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2, 2020</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>determination of normal values for SEBT</measure>
    <time_frame>one day</time_frame>
    <description>star excursion balance test : it is a functionnal test for predicting the risk of injury</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Handball Players</condition>
  <eligibility>
    <study_pop>
      <textblock>
        national or international hanball women players, aged from 14 to 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women&#xD;
&#xD;
          -  age from 14 to 18 years old&#xD;
&#xD;
          -  national or international level for handball&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no french language&#xD;
&#xD;
          -  players who don't understand the instructions to perform the test&#xD;
&#xD;
          -  Refusal to perform the test&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>handball women players</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc BEAUMONT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brest</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hand ball</keyword>
  <keyword>evaluation</keyword>
  <keyword>risk of injury</keyword>
  <keyword>women</keyword>
  <!-- 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/NCT03797430
org study id: SEBTHAND ( 29BRC18.0254)
nct id: NCT03797430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim of this study is to determine normal values for SEBT in young national or
      international handball women players for determining specific level for SEBT to predict risk
      of injury
observational model: Cohort
time perspective: Prospective
measure: determination of normal values for SEBT
time frame: one day
description: star excursion balance test : it is a functionnal test for predicting the risk of injury
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: handball women players
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc BEAUMONT, PhD
role: Principal Investigator
affiliation: CHU Brest
responsible party type: Sponsor