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/NCT06009822</url>
    </required_header>
    <id_info>
      <org_study_id>Iayas4</org_study_id>
      <nct_id>NCT06009822</nct_id>
    </id_info>
    <brief_title>Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction</brief_title>
    <official_title>Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Our aim in this study is to examine the functional and clinical results of patients who have&#xD;
        undergone MPFL reconstruction at least 2 years after the operation. The presence of&#xD;
        kinesiophobia of the patients will be evaluated and its relationship with functional outcomes&#xD;
        will be examined.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Kinesiophobia</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knee Score</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Function will be measured by the Lysholm knee score.The total score on the Lysholm Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:&#xD;
  95-100: Excellent knee function 84-94: Good knee function 65-83: Fair knee function Below 65: Poor knee function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patellofemoral Knee Score</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Function will be measured by the Kujala Patellofemoral Knee Score. The total score on the Kujala Patellofemoral Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:&#xD;
  100: No limitations or symptoms 85-99: Mild limitations or symptoms 70-84: Moderate limitations or symptoms Below 70: Severe limitations or symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single-leg hop test</measure>
      <time_frame>up to 3 months</time_frame>
      <description>The single-leg hop distance is an indicator of lower extremity function. The test evaluates an individual's lower limb strength, power, and overall functional performance. It specifically focuses on assessing an individual's ability to generate power and stability while performing a single-leg hop for maximal distance. When performing the test, the individual starts by standing on one leg at the starting point. The opposite leg is lifted slightly off the ground, and the hands can be placed on the hips or kept at the sides for balance. On the command to start, the individual hops forward on the single leg, aiming to jump as far as possible while maintaining control and balance. Perform 3 repetitions and record the longest distance jumped.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dynamic balance</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Dynamic balance will be measured by Y Balance Test. The Y Balance Test involves a person standing on one leg while reaching in anterior (forward), posteromedial (backward and to the side), and posterolateral (backward and to the other side) directions with the other leg. The person places their stance foot at the starting point on the central part of the Y-shaped device.While maintaining balance on the stance leg, the person reaches the free leg as far as possible along each of the three arms of the Y.The distance reached in each direction is measured and recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Static balance</measure>
      <time_frame>up to 3 months</time_frame>
      <description>Static balance will be measured using a Biodex Balance System, single leg sway index test procedure. The device reports the person's body oscillations as sway index. A high stability index indicates poor postural control.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Medial Patellofemoral Dislocation</condition>
    <condition>Kinesiophobia</condition>
    <arm_group>
      <arm_group_label>Patients with Medial Patellofemoral Ligament reconstruction</arm_group_label>
      <description>Must have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction.&#xD;
  At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Postoperative outcome measurements</intervention_name>
      <description>Kinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated.&#xD;
  Biodex Bio-balance system device will be used for single leg sway index.</description>
      <arm_group_label>Patients with Medial Patellofemoral Ligament reconstruction</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who underwent unilateral MPFL reconstruction in the Department of Orthopedics and&#xD;
          Traumatology, Gazi University Hospital between 2004 and 2019&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction&#xD;
  &#xD;
            -  At least 2 years after the operation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patellar instability&#xD;
  &#xD;
            -  Knee ligament injury&#xD;
  &#xD;
            -  Meniscus injury&#xD;
  &#xD;
            -  Knee osteoarthritis&#xD;
  &#xD;
            -  Ankle ligament injury&#xD;
  &#xD;
            -  Ankle osteoarthritis&#xD;
  &#xD;
            -  Any neurological disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Zeynep Hazar</last_name>
      <role>Study Director</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>İnci H Ayas, Msc</last_name>
      <phone>+90 0312 216 26 01</phone>
      <email>inciayass@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zeynep Hazar, PhD</last_name>
      <phone>+90 0312 216 26 01</phone>
      <email>zhazar@gazi.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zeynep Hazar, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>İnci Hazal Ayas</investigator_full_name>
      <investigator_title>Research asistant (PT)</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kinesiophobia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</ipd_description>
    </patient_data>
    <!-- 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/NCT06009822
  org study id: Iayas4
  nct id: NCT06009822
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Our aim in this study is to examine the functional and clinical results of patients who have
        undergone MPFL reconstruction at least 2 years after the operation. The presence of
        kinesiophobia of the patients will be evaluated and its relationship with functional outcomes
        will be examined.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Kinesiophobia
  time frame: up to 3 months
  description: Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.
  measure: Knee Score
  time frame: up to 3 months
  description: Function will be measured by the Lysholm knee score.The total score on the Lysholm Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:
  95-100: Excellent knee function 84-94: Good knee function 65-83: Fair knee function Below 65: Poor knee function
  measure: Patellofemoral Knee Score
  time frame: up to 3 months
  description: Function will be measured by the Kujala Patellofemoral Knee Score. The total score on the Kujala Patellofemoral Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation:
  100: No limitations or symptoms 85-99: Mild limitations or symptoms 70-84: Moderate limitations or symptoms Below 70: Severe limitations or symptoms
  measure: Single-leg hop test
  time frame: up to 3 months
  description: The single-leg hop distance is an indicator of lower extremity function. The test evaluates an individual's lower limb strength, power, and overall functional performance. It specifically focuses on assessing an individual's ability to generate power and stability while performing a single-leg hop for maximal distance. When performing the test, the individual starts by standing on one leg at the starting point. The opposite leg is lifted slightly off the ground, and the hands can be placed on the hips or kept at the sides for balance. On the command to start, the individual hops forward on the single leg, aiming to jump as far as possible while maintaining control and balance. Perform 3 repetitions and record the longest distance jumped.
  measure: Dynamic balance
  time frame: up to 3 months
  description: Dynamic balance will be measured by Y Balance Test. The Y Balance Test involves a person standing on one leg while reaching in anterior (forward), posteromedial (backward and to the side), and posterolateral (backward and to the other side) directions with the other leg. The person places their stance foot at the starting point on the central part of the Y-shaped device.While maintaining balance on the stance leg, the person reaches the free leg as far as possible along each of the three arms of the Y.The distance reached in each direction is measured and recorded.
  measure: Static balance
  time frame: up to 3 months
  description: Static balance will be measured using a Biodex Balance System, single leg sway index test procedure. The device reports the person's body oscillations as sway index. A high stability index indicates poor postural control.
  arm group label: Patients with Medial Patellofemoral Ligament reconstruction
  description: Must have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction.
  At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction.
  intervention type: Other
  intervention name: Postoperative outcome measurements
  description: Kinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated.
  Biodex Bio-balance system device will be used for single leg sway index.
  arm group label: Patients with Medial Patellofemoral Ligament reconstruction
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Zeynep Hazar
  role: Study Director
  affiliation: Gazi University
  last name: İnci H Ayas, Msc
  phone: +90 0312 216 26 01
  email: inciayass@gmail.com
  last name: Zeynep Hazar, PhD
  phone: +90 0312 216 26 01
  email: zhazar@gazi.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: İnci Hazal Ayas
  investigator title: Research asistant (PT)
  mesh term: Kinesiophobia
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.