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/NCT06001216</url>
    </required_header>
    <id_info>
      <org_study_id>GO 21/1377</org_study_id>
      <nct_id>NCT06001216</nct_id>
    </id_info>
    <brief_title>The Relationship of ACWR and FMS With Injury Risk in Adolescent Players</brief_title>
    <official_title>The Relationship of Acute-Chronic Workload Ratio and Functional Movement Screen With Injury Risk in Adolescent Team Sport Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe University</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>
        In this study, we examine how acute to chronic workload ratio and functional movement screen&#xD;
        scores relate to injury risk in teenage athletes who play team sports.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At least 60 volunteer athletes who have played team sport for at least 1 year, have not been&#xD;
        away from the field for more than 2 weeks, 15 years and older are planned to include this&#xD;
        study. All participating athletes in this study will sign an informed consent form then their&#xD;
        demographic information will be recorded. The injury risk of athletes will be evaluated by&#xD;
        functional movement screen. The functional movement screen is a test battery consisting of 7&#xD;
        tests. These tests are deep squat, hurdle step, in-line lunge, active straight-leg raise,&#xD;
        trunk stability push-up, rotary stability and shoulder mobility. To calculate the&#xD;
        acute-chronic workload, internal workloads during training and/or matches will be added up&#xD;
        over a period of 8 weeks. As part of the study, health professionals on the team will provide&#xD;
        injury information for the athletes. Sports injuries will be classified based on the type of&#xD;
        injury (contact or non-contact) and the area of the body affected. The severity of the injury&#xD;
        will be determined as follows: minimal (1-3 days of missed sports activity), mild (4-7 days&#xD;
        of missed sports activity), moderate (1-4 weeks of missed sports activity), and severe (4 or&#xD;
        more weeks of missed sports activity).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 18, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Functional Movement Screen</measure>
      <time_frame>baseline</time_frame>
      <description>To assess the risk of injury, we will utilize the Functional Movement Screen.The FMS test scores range from 0 to 3, with 0 being the worst and 3 being the best. The highest possible score is 21. Individuals who score 14 points or lower are at a higher risk for injury, while those who score above 14 points have a lower risk of injury.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute chronic workload ratio</measure>
      <time_frame>8 weeks</time_frame>
      <description>To determine an athlete's workload, we ask them to rate their training time and fatigue level using the modified Borg scale after each session. We then calculate the workload by dividing the acute workload by the chronic workload using specific formulas.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Injury</measure>
      <time_frame>8 weeks</time_frame>
      <description>The input will be provided by the health professionals on the team.</description>
    </primary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Injury;Sports</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All volunteer employees who are over the age of 15, have been playing a team sport for at&#xD;
          least one year, have not been away from their spor for more than two weeks and meet the&#xD;
          inclusion criteria of the study will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be over 16 years old,&#xD;
  &#xD;
            -  Participating in a team sport for at least one year,&#xD;
  &#xD;
            -  The players who have not stayed away from their sport for more than two weeks,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any history of orthopedic or neurological injury or pain that may interfere with&#xD;
               normal training or competition during assessment,&#xD;
  &#xD;
            -  Structural deformities such as scoliosis and leg length inequality,&#xD;
  &#xD;
            -  Their level of activity differs from other athletes in the same sport will be excluded&#xD;
               from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aynur Demirel</last_name>
      <phone>+903123051576</phone>
      <email>aynur.demirel@hacettepe.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cansu Akkuş</last_name>
      <phone>+905426582390</phone>
      <email>cansu.akkus@hacettepe.edu.tr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Aynur Demirel</investigator_full_name>
      <investigator_title>Associate Professor</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>
    </condition_browse>
    <!-- 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/NCT06001216
  org study id: GO 21/1377
  nct id: NCT06001216
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, we examine how acute to chronic workload ratio and functional movement screen
        scores relate to injury risk in teenage athletes who play team sports.
  At least 60 volunteer athletes who have played team sport for at least 1 year, have not been
        away from the field for more than 2 weeks, 15 years and older are planned to include this
        study. All participating athletes in this study will sign an informed consent form then their
        demographic information will be recorded. The injury risk of athletes will be evaluated by
        functional movement screen. The functional movement screen is a test battery consisting of 7
        tests. These tests are deep squat, hurdle step, in-line lunge, active straight-leg raise,
        trunk stability push-up, rotary stability and shoulder mobility. To calculate the
        acute-chronic workload, internal workloads during training and/or matches will be added up
        over a period of 8 weeks. As part of the study, health professionals on the team will provide
        injury information for the athletes. Sports injuries will be classified based on the type of
        injury (contact or non-contact) and the area of the body affected. The severity of the injury
        will be determined as follows: minimal (1-3 days of missed sports activity), mild (4-7 days
        of missed sports activity), moderate (1-4 weeks of missed sports activity), and severe (4 or
        more weeks of missed sports activity).
  observational model: Case-Only
  time perspective: Other
  measure: Functional Movement Screen
  time frame: baseline
  description: To assess the risk of injury, we will utilize the Functional Movement Screen.The FMS test scores range from 0 to 3, with 0 being the worst and 3 being the best. The highest possible score is 21. Individuals who score 14 points or lower are at a higher risk for injury, while those who score above 14 points have a lower risk of injury.
  measure: Acute chronic workload ratio
  time frame: 8 weeks
  description: To determine an athlete's workload, we ask them to rate their training time and fatigue level using the modified Borg scale after each session. We then calculate the workload by dividing the acute workload by the chronic workload using specific formulas.
  measure: Injury
  time frame: 8 weeks
  description: The input will be provided by the health professionals on the team.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aynur Demirel
  phone: +903123051576
  email: aynur.demirel@hacettepe.edu.tr
  last name: Cansu Akkuş
  phone: +905426582390
  email: cansu.akkus@hacettepe.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Aynur Demirel
  investigator title: Associate Professor
  mesh term: Wounds and Injuries
  mesh term: Athletic Injuries