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/NCT06006897</url>
    </required_header>
    <id_info>
      <org_study_id>Effects of COVID on scoliosis</org_study_id>
      <nct_id>NCT06006897</nct_id>
    </id_info>
    <brief_title>Pain, Physical Activity, Posture and Quality of Life in Post-COVID-19 Individuals With Idiopathic Scoliosis</brief_title>
    <official_title>Pain, Physical Activity, Posture and Quality of Life in Individuals With Idiopathic Scoliosis Who Have Had COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Izmir Democracy University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Izmir Democracy 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>
        It is not known to what extent the COVID-19 virus affects individuals with scoliosis during&#xD;
        the prolonged COVID-19 pandemic. Therefore, in this study it was aimed to comparatively&#xD;
        investigate pain severity, posture disorders that can be assessed by artificial intelligence,&#xD;
        physical activity levels and quality of life in individuals with idiopathic scoliosis with&#xD;
        and without COVID-19.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Various physical and psychological disorders observed in individuals with scoliosis have&#xD;
        worsened during the pandemic period. However, it is still not fully known to what extent the&#xD;
        COVID-19 virus affects individuals with scoliosis during the prolonged COVID-19 pandemic. For&#xD;
        this reason, this study aimed to comparatively investigate pain severity, posture disorders&#xD;
        that can be assessed by artificial intelligence, physical activity levels and quality of life&#xD;
        in individuals with idiopathic scoliosis with and without COVID-19.&#xD;
  &#xD;
        With the findings obtained from this way, it is expect that artificial intelligence&#xD;
        technology will shed light on a new approach to the rehabilitation of individuals with&#xD;
        idiopathic scoliosis who have suffered from COVID-19. In addition, if there is more pain,&#xD;
        posture disorders, physical inactivity and quality of life disorders in individuals with&#xD;
        scoliosis who have previously experienced COVID-19, it is also aimed to bring them to light.&#xD;
        In this way, it will be possible to provide more specific direction to the rehabilitation of&#xD;
        these individuals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Daily average step count</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The step counts will be recorded via pedometers everyday within 3 days after confirming enrolment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain Intensity measured with the Numerical Rating Scale.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The score will be evaluated using Scoliosis Research Society-22 (SRS-22) questionnaire. SRS-22 contains 22 questions. Each question is scored from 1 (worst) to 5 (best), with higher scores indicating better results. The minimum score obtained from the questionnaire is 22 and the maximum total score is 110.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Posture assessment</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Posture deviation will be determined according to the deviation score in the joint centers obtained by photographing the posture of the individuals and uploading them to the system. Posture assessment will be made with a mobile application based on the concept of postural analysis with artificial intelligence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Degree of vertebral rotation</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Degree of vertebral rotation will be evaluated through a scoliometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain severity</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Pain severity will be assessed via Pressure Algometry</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>COVID-19 Respiratory Infection</condition>
    <condition>Idiopathic Scoliosis</condition>
    <arm_group>
      <arm_group_label>Post-COVID-19 group</arm_group_label>
      <description>This group will consist of individuals with idiopathic scoliosis who have had COVID-19.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>The control group will consist of individuals with idiopathic scoliosis without post-COVID-19.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Evaluations of post-COVID-19 individuals</intervention_name>
      <description>In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis with post-COVID-19 individuals. The data to be obtained from all these evaluations will be collected from the individuals at one time and over a period of approximately 1 hour at the most. Step count tracking with pedometer will be done for each individual for 3 days.</description>
      <arm_group_label>Post-COVID-19 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical evaluations of non-post-COVID-19 individuals</intervention_name>
      <description>In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis without post-COVID-19 individuals.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          At least 25 idiopathic scoliosis with post-COVID-19 will be included in the main group and&#xD;
          at least 25 idiopathic scoliosis without post-COVID-19 will be included in control group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria for individuals with idiopathic scoliosis who have experienced COVID-19:&#xD;
  &#xD;
            -  being 18 years of age or older&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
            -  Having been diagnosed with idiopathic scoliosis&#xD;
  &#xD;
            -  Being able to walk independently&#xD;
  &#xD;
            -  Having been diagnosed with COVID-19 and having recovered and been discharged.&#xD;
  &#xD;
          Inclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;&#xD;
  &#xD;
            -  being 18 years of age or older&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
            -  Being diagnosed with idiopathic scoliosis&#xD;
  &#xD;
          Exclusion criteria for individuals with idiopathic scoliosis who have had COVID-19;&#xD;
  &#xD;
            -  Having been diagnosed with COVID-19 in the last 15 days&#xD;
  &#xD;
            -  Being suspected of COVID-19&#xD;
  &#xD;
            -  Having mental problems that may affect cooperation&#xD;
  &#xD;
            -  Having an acute or chronic infection that may affect the evaluations to be made within&#xD;
               the scope of the study.&#xD;
  &#xD;
            -  Participating in any professional sports activity&#xD;
  &#xD;
            -  Having any surgery to prevent walking, having a chronic disease,&#xD;
               orthopedic/neurological/cardiopulmonary disease, physical or mental disability and/or&#xD;
               cognitive impairment&#xD;
  &#xD;
            -  Using analgesics and other interactive drugs that will affect assessments&#xD;
  &#xD;
            -  Being pregnant&#xD;
  &#xD;
          Exclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;&#xD;
  &#xD;
            -  Having had at least one COVID-19&#xD;
  &#xD;
            -  Being suspected of COVID-19&#xD;
  &#xD;
            -  Having any mental or physical disability&#xD;
  &#xD;
            -  Having any acute or chronic illness&#xD;
  &#xD;
            -  Having analgesic drug use that will affect the evaluations . Being pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>GÜLŞAH BARĞI</last_name>
      <role>Study Director</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>MERVE NUR YÜKSEL</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>ALİ ERTUĞRUL</last_name>
      <role>Principal Investigator</role>
      <affiliation>Balikesir Ataturk City Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>RUKİYE YAZICI</last_name>
      <role>Principal Investigator</role>
      <affiliation>Atatürk, Balikesir State Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>GÜLŞAH BARĞI</last_name>
      <phone>+90 232 299 0739</phone>
      <email>gulsahbargi35@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>MERVE NUR YÜKSEL</last_name>
      <email>merv.yuksel94@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Kieser DC, Bourghli A, Larrieu D, Cawley DT, Hayashi K, Jakinapally S, Pizones J, Boissiere L, Obeid I. Impact of COVID-19 on the pain and disability of patients with adult spinal deformity. Spine Deform. 2021 Jul;9(4):1073-1076. doi: 10.1007/s43390-021-00315-5. Epub 2021 Mar 2.</citation>
      <PMID>33651340</PMID>
    </reference>
    <reference>
      <citation>Suarez-Huerta ML, Gomez-Rice A, Carvajal Alvarez M, Vazquez Vecilla IC, Izquierdo-Nunez E, Fernandez-Gonzalez M, Zuniga-Gomez L, Betegon-Nicolas J, Sanchez-Campos S. Effect of COVID-19 on quality of life of persons aged &gt;70 years with adult spinal deformity: A cross-sectional case-control study. Medicine (Baltimore). 2022 Aug 19;101(33):e29954. doi: 10.1097/MD.0000000000029954.</citation>
      <PMID>35984207</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Democracy University</investigator_affiliation>
      <investigator_full_name>Gulsah Bargi</investigator_full_name>
      <investigator_title>Associate Professor, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>pain</keyword>
    <keyword>physical activity</keyword>
    <keyword>posture</keyword>
    <keyword>quality of life</keyword>
    <keyword>Scoliosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Scoliosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06006897
  org study id: Effects of COVID on scoliosis
  nct id: NCT06006897
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It is not known to what extent the COVID-19 virus affects individuals with scoliosis during
        the prolonged COVID-19 pandemic. Therefore, in this study it was aimed to comparatively
        investigate pain severity, posture disorders that can be assessed by artificial intelligence,
        physical activity levels and quality of life in individuals with idiopathic scoliosis with
        and without COVID-19.
  Various physical and psychological disorders observed in individuals with scoliosis have
        worsened during the pandemic period. However, it is still not fully known to what extent the
        COVID-19 virus affects individuals with scoliosis during the prolonged COVID-19 pandemic. For
        this reason, this study aimed to comparatively investigate pain severity, posture disorders
        that can be assessed by artificial intelligence, physical activity levels and quality of life
        in individuals with idiopathic scoliosis with and without COVID-19.
  
        With the findings obtained from this way, it is expect that artificial intelligence
        technology will shed light on a new approach to the rehabilitation of individuals with
        idiopathic scoliosis who have suffered from COVID-19. In addition, if there is more pain,
        posture disorders, physical inactivity and quality of life disorders in individuals with
        scoliosis who have previously experienced COVID-19, it is also aimed to bring them to light.
        In this way, it will be possible to provide more specific direction to the rehabilitation of
        these individuals.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Daily average step count
  time frame: through study completion, an average of 1 year
  description: The step counts will be recorded via pedometers everyday within 3 days after confirming enrolment.
  measure: Pain Intensity measured with the Numerical Rating Scale.
  time frame: through study completion, an average of 1 year
  description: Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).
  measure: Total quality of life score evaluated by Scoliosis Research Society-22 (SRS-22) questionnaire.
  time frame: through study completion, an average of 1 year
  description: The score will be evaluated using Scoliosis Research Society-22 (SRS-22) questionnaire. SRS-22 contains 22 questions. Each question is scored from 1 (worst) to 5 (best), with higher scores indicating better results. The minimum score obtained from the questionnaire is 22 and the maximum total score is 110.
  measure: Posture assessment
  time frame: through study completion, an average of 1 year
  description: Posture deviation will be determined according to the deviation score in the joint centers obtained by photographing the posture of the individuals and uploading them to the system. Posture assessment will be made with a mobile application based on the concept of postural analysis with artificial intelligence.
  measure: Degree of vertebral rotation
  time frame: through study completion, an average of 1 year
  description: Degree of vertebral rotation will be evaluated through a scoliometer.
  measure: Pain severity
  time frame: through study completion, an average of 1 year
  description: Pain severity will be assessed via Pressure Algometry
  arm group label: Post-COVID-19 group
  description: This group will consist of individuals with idiopathic scoliosis who have had COVID-19.
  arm group label: Control group
  description: The control group will consist of individuals with idiopathic scoliosis without post-COVID-19.
  intervention type: Other
  intervention name: Physical Evaluations of post-COVID-19 individuals
  description: In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis with post-COVID-19 individuals. The data to be obtained from all these evaluations will be collected from the individuals at one time and over a period of approximately 1 hour at the most. Step count tracking with pedometer will be done for each individual for 3 days.
  arm group label: Post-COVID-19 group
  intervention type: Other
  intervention name: Physical evaluations of non-post-COVID-19 individuals
  description: In this study, scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in idiopathic scoliosis without post-COVID-19 individuals.
  arm group label: Control group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: GÜLŞAH BARĞI
  role: Study Director
  affiliation: Izmir Democracy University
  last name: MERVE NUR YÜKSEL
  role: Principal Investigator
  affiliation: Izmir Democracy University
  last name: ALİ ERTUĞRUL
  role: Principal Investigator
  affiliation: Balikesir Ataturk City Hospital
  last name: RUKİYE YAZICI
  role: Principal Investigator
  affiliation: Atatürk, Balikesir State Hospital
  last name: GÜLŞAH BARĞI
  phone: +90 232 299 0739
  email: gulsahbargi35@gmail.com
  last name: MERVE NUR YÜKSEL
  email: merv.yuksel94@gmail.com
  citation: Kieser DC, Bourghli A, Larrieu D, Cawley DT, Hayashi K, Jakinapally S, Pizones J, Boissiere L, Obeid I. Impact of COVID-19 on the pain and disability of patients with adult spinal deformity. Spine Deform. 2021 Jul;9(4):1073-1076. doi: 10.1007/s43390-021-00315-5. Epub 2021 Mar 2.
  PMID: 33651340
  citation: Suarez-Huerta ML, Gomez-Rice A, Carvajal Alvarez M, Vazquez Vecilla IC, Izquierdo-Nunez E, Fernandez-Gonzalez M, Zuniga-Gomez L, Betegon-Nicolas J, Sanchez-Campos S. Effect of COVID-19 on quality of life of persons aged >70 years with adult spinal deformity: A cross-sectional case-control study. Medicine (Baltimore). 2022 Aug 19;101(33):e29954. doi: 10.1097/MD.0000000000029954.
  PMID: 35984207
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Democracy University
  investigator full name: Gulsah Bargi
  investigator title: Associate Professor, Principal Investigator
  mesh term: COVID-19
  mesh term: Respiratory Tract Infections
  mesh term: Scoliosis
  sharing ipd: No