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/NCT06001229</url>
    </required_header>
    <id_info>
      <org_study_id>GO 22/540</org_study_id>
      <nct_id>NCT06001229</nct_id>
    </id_info>
    <brief_title>The Micheli Functional Scale's Validity and Reliability</brief_title>
    <official_title>The Micheli Functional Scale's Validity and Reliability in Turkish Sport Groups</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>
        The purpose of this study is to assess the reliability and validity of the &quot;Micheli&#xD;
        Functional Scale&quot; in the Turkish context.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include a minimum of 80 individuals who are 16 years old or above, have been&#xD;
        engaged in the same sports activity for at least two years, participate in physically&#xD;
        demanding activities for at least three days a week, and possess the ability to read and&#xD;
        write Turkish. Before participating in the study, athletes will be required to sign an&#xD;
        informed consent form. Their demographic information will then be recorded.Before conducting&#xD;
        the test, we will gather information about the athletes' history of low back pain using the&#xD;
        extended Nordic musculoskeletal questionnaire. We will also use this questionnaire to&#xD;
        identify any other musculoskeletal issues that the person may have.Two Turkish translators,&#xD;
        fluent in English, will independently translate the original Micheli Functional Scale into&#xD;
        Turkish. They will then discuss their translations and create a common one. The resulting&#xD;
        translation will be translated back into English by two native English speakers who are also&#xD;
        proficient in Turkish. These translations will be reviewed and combined into a single&#xD;
        version. A Turkish scientist will evaluate the questionnaire for its suitability in the&#xD;
        Turkish language. The final version will be tested on a small pilot group to determine its&#xD;
        comprehensibility. After this, the questionnaire will be administered to the entire study&#xD;
        group. To assess the validity of the Micheli Functional Scale, we will use the Oswestry&#xD;
        Functional Questionnaire and the Ronald Morris Disability Questionnaire. One week after the&#xD;
        test, we will repeat these surveys.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 18, 2023</start_date>
    <completion_date type="Anticipated">June 22, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 22, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Micheli Functional Scale</measure>
      <time_frame>baseline and 1 week later</time_frame>
      <description>Evaluates the function linked to low back pain in athletes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oswestry Disability Index</measure>
      <time_frame>baseline and 1 week later</time_frame>
      <description>Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Roland morris disability questionnaire</measure>
      <time_frame>baseline and 1 week later</time_frame>
      <description>It is a questionnaire used to evaluate the disability level of individuals with low back pain. This questionnaire, consisting of 24 items, questions the person's social life, walking, sitting, standing, getting up from a chair, climbing stairs, dressing, personal care, pain, appetite, sleep, and psychological impact. The person answers the questions with yes and no. Yes is scored as 1 point and no as 0 points. The maximum score is &quot;24&quot; and the minimum score is &quot;0&quot;. As the total score increases, the level of physical exposure also increases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The musculoskeletal system problem</measure>
      <time_frame>baseline</time_frame>
      <description>Nordic Musculoskeletal System Questionnaire</description>
    </secondary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Low Back Pain</condition>
    <eligibility>
      <study_pop>
        <textblock>
          To be eligible for the study, participants must be at least 16 years old, have been&#xD;
          practicing the same sport for a minimum of 2 years, and engage in high-effort physical&#xD;
          activity for at least 3 days per week. Additionally, those who are able to read and write&#xD;
          in Turkish will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  16 years old and over&#xD;
  &#xD;
            -  Having been doing the same sport for at least 2 years,&#xD;
  &#xD;
            -  Participating in sports activities or activities that require a high level of effort&#xD;
               at least 3 days a week,&#xD;
  &#xD;
            -  Able to read and write Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a cognitive problem that prevents him from understanding and answering the&#xD;
               questions or is taking a drug that may cause them,&#xD;
  &#xD;
            -  Having a history of orthopedic or neurological injury or pain at a level that may&#xD;
               prevent training or competition during the evaluation,&#xD;
  &#xD;
            -  History of spine/lower and upper extremity surgery,&#xD;
  &#xD;
            -  Structural deformities such as scoliosis and kyphosis,&#xD;
  &#xD;
            -  Those with trap neuropathy will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</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>Low Back Pain</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/NCT06001229
  org study id: GO 22/540
  nct id: NCT06001229
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the reliability and validity of the "Micheli
        Functional Scale" in the Turkish context.
  The study will include a minimum of 80 individuals who are 16 years old or above, have been
        engaged in the same sports activity for at least two years, participate in physically
        demanding activities for at least three days a week, and possess the ability to read and
        write Turkish. Before participating in the study, athletes will be required to sign an
        informed consent form. Their demographic information will then be recorded.Before conducting
        the test, we will gather information about the athletes' history of low back pain using the
        extended Nordic musculoskeletal questionnaire. We will also use this questionnaire to
        identify any other musculoskeletal issues that the person may have.Two Turkish translators,
        fluent in English, will independently translate the original Micheli Functional Scale into
        Turkish. They will then discuss their translations and create a common one. The resulting
        translation will be translated back into English by two native English speakers who are also
        proficient in Turkish. These translations will be reviewed and combined into a single
        version. A Turkish scientist will evaluate the questionnaire for its suitability in the
        Turkish language. The final version will be tested on a small pilot group to determine its
        comprehensibility. After this, the questionnaire will be administered to the entire study
        group. To assess the validity of the Micheli Functional Scale, we will use the Oswestry
        Functional Questionnaire and the Ronald Morris Disability Questionnaire. One week after the
        test, we will repeat these surveys.
  observational model: Other
  time perspective: Other
  measure: Micheli Functional Scale
  time frame: baseline and 1 week later
  description: Evaluates the function linked to low back pain in athletes.
  measure: Oswestry Disability Index
  time frame: baseline and 1 week later
  description: Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases.
  measure: Roland morris disability questionnaire
  time frame: baseline and 1 week later
  description: It is a questionnaire used to evaluate the disability level of individuals with low back pain. This questionnaire, consisting of 24 items, questions the person's social life, walking, sitting, standing, getting up from a chair, climbing stairs, dressing, personal care, pain, appetite, sleep, and psychological impact. The person answers the questions with yes and no. Yes is scored as 1 point and no as 0 points. The maximum score is "24" and the minimum score is "0". As the total score increases, the level of physical exposure also increases.
  measure: The musculoskeletal system problem
  time frame: baseline
  description: Nordic Musculoskeletal System Questionnaire
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 25 Years
  healthy volunteers: No
  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: Low Back Pain