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/NCT05970692</url>
    </required_header>
    <id_info>
      <org_study_id>BEU-KTS-01</org_study_id>
      <nct_id>NCT05970692</nct_id>
    </id_info>
    <brief_title>Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale</brief_title>
    <official_title>Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ilke KARA</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bitlis Eren University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dokuz Eylul 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>
        This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L&#xD;
        scale) and to perform validity and reliability evaluations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 26, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 13, 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>Atroshi-Lyrén 6-item symptoms scale</measure>
      <time_frame>1 week</time_frame>
      <description>The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>Healthy individuals aged between 18-65 years old</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CTS Group</arm_group_label>
      <description>CTS patients aged between 18-65 years old</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          CTS patients aged between 18-65 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 18-65 years old,&#xD;
  &#xD;
            -  Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1&#xD;
               month,&#xD;
  &#xD;
            -  Assessed through provocation tests and physical examination to match the median nerve&#xD;
               distribution.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not willing to participate in the study,&#xD;
  &#xD;
            -  Clinical or electrophysiological signs of proximal nerve compression,&#xD;
  &#xD;
            -  Diabetes or other metabolic disease,&#xD;
  &#xD;
            -  Rheumatoid arthritis or other general inflammatory diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tülay Çevik Saldıran, PhD</last_name>
      <phone>+90 (434) 222 83 32</phone>
      <email>tcsaldiran@beu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bitlis Eren University</name>
        <address>
          <city>Bitlis</city>
          <zip>13000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Tülay Çevik Saldıran, PhD</last_name>
        <phone>+90 (434) 222 83 32</phone>
        <email>tcsaldiran@beu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
      <investigator_full_name>Ilke KARA</investigator_full_name>
      <investigator_title>Co-Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Carpal Tunnel Syndrome</keyword>
    <keyword>Pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05970692
  org study id: BEU-KTS-01
  nct id: NCT05970692
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L
        scale) and to perform validity and reliability evaluations.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Atroshi-Lyrén 6-item symptoms scale
  time frame: 1 week
  description: The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)
  arm group label: Healthy Controls
  description: Healthy individuals aged between 18-65 years old
  arm group label: CTS Group
  description: CTS patients aged between 18-65 years old
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tülay Çevik Saldıran, PhD
  phone: +90 (434) 222 83 32
  email: tcsaldiran@beu.edu.tr
  facility: 
  contact: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dokuz Eylul University
  investigator full name: Ilke KARA
  investigator title: Co-Principal Investigator
  mesh term: Carpal Tunnel Syndrome
  sharing ipd: Undecided