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/NCT06015412</url>
    </required_header>
    <id_info>
      <org_study_id>2023/11-21</org_study_id>
      <nct_id>NCT06015412</nct_id>
    </id_info>
    <brief_title>Physical Parameters in Osteoarthritis Stages</brief_title>
    <official_title>Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk 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>
        To investigate the extent to which pain, functionality, and quality of life change over the&#xD;
        progression of osteoarthritis grades.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>2 minutes</time_frame>
      <description>a 10-cm straight line with 0 on one end indicating no pain and 10 on the other end signifying unbearable pain. The participants were asked to mark the intensity of their current pain on the line</description>
    </primary_outcome>
    <primary_outcome>
      <measure>two-minute walk test (2MWT)</measure>
      <time_frame>2 minutes</time_frame>
      <description>A 45-meter corridor was used for the 2MWT. The start and end points were marked, and the participants were asked to walk at a normal pace within these boundaries. The distance covered in two minutes was recorded</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>10 minutes</time_frame>
      <description>The questionnaire consists of 24 items, each scored from 0 to 4. The total score is obtained by summing the point equivalents of the responses given to all items. A higher score indicates poorer functionality</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nottingham Health Profile (NHP)</measure>
      <time_frame>10 minutes</time_frame>
      <description>This tool comprises 38 questions in six domains, namely energy, pain, social isolation, physical mobility, emotional reactions, and sleep. Each domain is scored from 0 to 100. The total score is obtained by summing the scores obtained from the six domains. High scores indicate a good quality of life.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">161</enrollment>
    <condition>Osteoarthritis</condition>
    <condition>Pain</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Grade 1 osteoarthritis</arm_group_label>
      <description>disease stages 1 according to the Kellgren-Lawrence radiographic classification system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grade 2 osteoarthritis</arm_group_label>
      <description>disease stages 2 according to the Kellgren-Lawrence radiographic classification system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grade 3 osteoarthritis</arm_group_label>
      <description>disease stages 3 according to the Kellgren-Lawrence radiographic classification system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grade 4 osteoarthritis</arm_group_label>
      <description>disease stages 4 according to the Kellgren-Lawrence radiographic classification system</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Radiographic classification</intervention_name>
      <description>disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system</description>
      <arm_group_label>Grade 1 osteoarthritis</arm_group_label>
      <arm_group_label>Grade 2 osteoarthritis</arm_group_label>
      <arm_group_label>Grade 3 osteoarthritis</arm_group_label>
      <arm_group_label>Grade 4 osteoarthritis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          diagnosed with the same grade of knee OA in both knees by the responsible physician in the&#xD;
          hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  having the same OA grade in both knees&#xD;
  &#xD;
            -  volunteering to participate in the study&#xD;
  &#xD;
            -  not having undergone previous lower extremity surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  neurological disorders;&#xD;
  &#xD;
            -  those with a history of surgery related to the lower extremities;&#xD;
  &#xD;
            -  those with orthopedic problems in the lower extremities, such as tendinopathy and&#xD;
               bursitis;&#xD;
  &#xD;
            -  those who had neurological, orthopedic, or cognitive disorders that would prevent&#xD;
               walking;&#xD;
  &#xD;
            -  those with a diagnosis of diabetes, obesity, or rheumatological disorders;&#xD;
  &#xD;
            -  those who had received intra-articular injection therapy within the last three months;&#xD;
  &#xD;
            -  and those with malignancy or perception problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Selcuk University</name>
        <address>
          <city>Konya</city>
          <state>Selçuklu</state>
          <zip>42130</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Emine Cihan</investigator_full_name>
      <investigator_title>Asst. Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</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/NCT06015412
  org study id: 2023/11-21
  nct id: NCT06015412
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the extent to which pain, functionality, and quality of life change over the
        progression of osteoarthritis grades.
  observational model: Other
  time perspective: Prospective
  measure: Visual Analog Scale (VAS)
  time frame: 2 minutes
  description: a 10-cm straight line with 0 on one end indicating no pain and 10 on the other end signifying unbearable pain. The participants were asked to mark the intensity of their current pain on the line
  measure: two-minute walk test (2MWT)
  time frame: 2 minutes
  description: A 45-meter corridor was used for the 2MWT. The start and end points were marked, and the participants were asked to walk at a normal pace within these boundaries. The distance covered in two minutes was recorded
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 10 minutes
  description: The questionnaire consists of 24 items, each scored from 0 to 4. The total score is obtained by summing the point equivalents of the responses given to all items. A higher score indicates poorer functionality
  measure: Nottingham Health Profile (NHP)
  time frame: 10 minutes
  description: This tool comprises 38 questions in six domains, namely energy, pain, social isolation, physical mobility, emotional reactions, and sleep. Each domain is scored from 0 to 100. The total score is obtained by summing the scores obtained from the six domains. High scores indicate a good quality of life.
  arm group label: Grade 1 osteoarthritis
  description: disease stages 1 according to the Kellgren-Lawrence radiographic classification system
  arm group label: Grade 2 osteoarthritis
  description: disease stages 2 according to the Kellgren-Lawrence radiographic classification system
  arm group label: Grade 3 osteoarthritis
  description: disease stages 3 according to the Kellgren-Lawrence radiographic classification system
  arm group label: Grade 4 osteoarthritis
  description: disease stages 4 according to the Kellgren-Lawrence radiographic classification system
  intervention type: Diagnostic Test
  intervention name: Radiographic classification
  description: disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
  arm group label: Grade 1 osteoarthritis
  arm group label: Grade 2 osteoarthritis
  arm group label: Grade 3 osteoarthritis
  arm group label: Grade 4 osteoarthritis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Emine Cihan
  investigator title: Asst. Prof
  mesh term: Osteoarthritis
  sharing ipd: No