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/NCT06009068</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004538</org_study_id>
      <nct_id>NCT06009068</nct_id>
    </id_info>
    <brief_title>Reliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy Subjects</brief_title>
    <official_title>Reliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        The purpose of this study is to investigate the intra- and inter-rater reliability and&#xD;
        concurrent validity of surgimap software for measuring the Q angle Surgimap (Nemaris Inc, New&#xD;
        York, NY, USA) is a dedicated spine measurement and surgical planning software which is used&#xD;
        in both the research works and the clinical rehabilitation. Q angle is considered to be an&#xD;
        index of the vector for action of the patellar tendon and extensors mechanism which is highly&#xD;
        affects the patellofemoral joint dysfunction and foot mechanics.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        specialised software for assessing the sagittal plane has arisen. Digital measuring software&#xD;
        of many types has been proved to be faster, more accurate, more precise, and less variable&#xD;
        than manual procedures. Angle measurement software is available in different formats and&#xD;
        applications. Surgimap is another programme used for measuring angles. The current software&#xD;
        has proven to be a godsend and is currently being used in the medical industry to measure&#xD;
        joint angles especially the spine alignment. The programme is also used for scientific&#xD;
        reasons, such as digital photo analysis. A recent study discovered that Surgimap software is&#xD;
        a viable approach for evaluating spinal postural angles in teenagers from varied standing&#xD;
        position perspectives using digital pictures.&#xD;
  &#xD;
        As there a lack of knowledge about the reliability and validity of the surgimap software to&#xD;
        measure the Q- angle. Therefore, The study will investigate the inter-rater, intra-rater&#xD;
        reliability and concurrent validity of the surgimap software for measuring the Q-angle.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The inter-rater, intra-rater reliability and concurrent validity of the surgimap software for measuring the Q-angle.</measure>
      <time_frame>3 months</time_frame>
      <description>the accuracy and consistency of surgimap software for measuring the q angle</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Reliability and Validity</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Surgimap soft ware</intervention_name>
      <description>20 healthy subjects will be recruited in the study, the q angle will be measured using goniometer and surgimap soft ware, 3 examiners will measure the q angles for the same individuals to check the inter rater reliability, and the test will be repeated after 2 days by the same examiners to check the intra rater reliability</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will be conducted in the out-patient clinic Faculty of physical therapy, Cairo&#xD;
          University. The expected duration to recruit patients and collect data is 3 months .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both male &amp; female&#xD;
  &#xD;
            -  Aged 18:25&#xD;
  &#xD;
            -  BMI 18.5: 25&#xD;
  &#xD;
            -  Normal foot posture as assessed by foot posture index.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects who have operations in the knee joint&#xD;
  &#xD;
            -  Subjects who have traumatic knee injury&#xD;
  &#xD;
            -  High arched or low arched foot.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 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>Cairo University</investigator_affiliation>
      <investigator_full_name>Aida Amir Nassif Naguib</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Surgimap</keyword>
    <keyword>Q-angle</keyword>
    <!-- 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/NCT06009068
  org study id: P.T.REC/012/004538
  nct id: NCT06009068
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to investigate the intra- and inter-rater reliability and
        concurrent validity of surgimap software for measuring the Q angle Surgimap (Nemaris Inc, New
        York, NY, USA) is a dedicated spine measurement and surgical planning software which is used
        in both the research works and the clinical rehabilitation. Q angle is considered to be an
        index of the vector for action of the patellar tendon and extensors mechanism which is highly
        affects the patellofemoral joint dysfunction and foot mechanics.
  specialised software for assessing the sagittal plane has arisen. Digital measuring software
        of many types has been proved to be faster, more accurate, more precise, and less variable
        than manual procedures. Angle measurement software is available in different formats and
        applications. Surgimap is another programme used for measuring angles. The current software
        has proven to be a godsend and is currently being used in the medical industry to measure
        joint angles especially the spine alignment. The programme is also used for scientific
        reasons, such as digital photo analysis. A recent study discovered that Surgimap software is
        a viable approach for evaluating spinal postural angles in teenagers from varied standing
        position perspectives using digital pictures.
  
        As there a lack of knowledge about the reliability and validity of the surgimap software to
        measure the Q- angle. Therefore, The study will investigate the inter-rater, intra-rater
        reliability and concurrent validity of the surgimap software for measuring the Q-angle.
  observational model: Other
  time perspective: Cross-Sectional
  measure: The inter-rater, intra-rater reliability and concurrent validity of the surgimap software for measuring the Q-angle.
  time frame: 3 months
  description: the accuracy and consistency of surgimap software for measuring the q angle
  intervention type: Other
  intervention name: Surgimap soft ware
  description: 20 healthy subjects will be recruited in the study, the q angle will be measured using goniometer and surgimap soft ware, 3 examiners will measure the q angles for the same individuals to check the inter rater reliability, and the test will be repeated after 2 days by the same examiners to check the intra rater reliability
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Aida Amir Nassif Naguib
  investigator title: Lecturer