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/NCT05999539</url>
    </required_header>
    <id_info>
      <org_study_id>ETK00-2023-0130</org_study_id>
      <nct_id>NCT05999539</nct_id>
    </id_info>
    <brief_title>Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees</brief_title>
    <official_title>Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life Between Faller and Non-faller Transtibial Amputees</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eastern Mediterranean University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eastern Mediterranean 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>
        Researchers aim to compare demographic characteristics, prosthesis type, functional capacity,&#xD;
        and quality of life between faller and non-faller transtibial amputees.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Unilateral transtibial level prosthetic users will be included in this study. After getting&#xD;
        the fall history of subjects, those who feel at least one time or more in the last year will&#xD;
        be accepted as the faller group. Demographic characteristics, functional capacity,&#xD;
        health-related quality of life, and prosthetic types used by amputees will be assessed. The&#xD;
        main differences between the faller and non-faller transtibial amputees will be analyzed with&#xD;
        the data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Two-minute walk test</measure>
      <time_frame>1 week</time_frame>
      <description>The test to be carried out to find out functional capacity, in a 30-meter-long area will be marked at 3-meter intervals, and the turning points will be determined with an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes and we will tell them that they can slow down and stop when they get tired. When 2 minutes are completed with a stopwatch, we will ask the individual to stop and record the walking distance in meters.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional Reach Test</measure>
      <time_frame>1 week</time_frame>
      <description>This test will be used to assess balance. The subjects will be asked to stand sideways next to the wall and wait with the shoulder in 90 degrees flexion, elbow in extension and fist closed without touching the wall with the arm close to the wall. The 3rd metacarpal head will be marked and the patient will be asked to reach as far as they can without taking a step, then the new location of the 3rd metacarpal head will be marked. Scoring will be determined by measuring the difference between the start and end position in centimeters. 3 attempts will be made and the best result will be taken.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed Up and Go Test</measure>
      <time_frame>1 week</time_frame>
      <description>This test will be used to assess fall risk. A distance of 3 meters will be determined in front of the chair, the individual is asked to get up from the chair and walk the determined distance, and the time elapsed will be recorded with a stopwatch with seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trinity Amputation and Prosthesis Experiences Scales</measure>
      <time_frame>1 week</time_frame>
      <description>This test is used to assess different aspects of amputees' experience of prosthesis use and quality of life. It gives a total score that means better when higher.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Amputation</condition>
    <condition>Fall</condition>
    <condition>Ambulation Difficulty</condition>
    <condition>Quality of Life</condition>
    <condition>Prosthesis User</condition>
    <arm_group>
      <arm_group_label>Faller transtibial prosthetic users</arm_group_label>
      <description>Transtibial prosthetic users who fell at least once in the last year.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-faller transtibial prosthetic users</arm_group_label>
      <description>Transtibial prosthetic users who have no fall history.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transtibial prosthesis</intervention_name>
      <description>A transtibial prosthesis to be used for at least one year.</description>
      <arm_group_label>Faller transtibial prosthetic users</arm_group_label>
      <arm_group_label>Non-faller transtibial prosthetic users</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The population will be the transtibial prosthetic users recorded in outpatient clinics&#xD;
          working on amputee rehabilitation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having the ability to walk at least 30-meter independently&#xD;
  &#xD;
            -  Using the transtibial prosthesis for at least one year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multiple limb amputees or prosthetic users&#xD;
  &#xD;
            -  Having prosthetic discomfort or stump ulcer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Eastern Mediterranean University</name>
        <address>
          <city>Mersin</city>
          <zip>33010</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yasin YURT, Assoc. Prof.</last_name>
        <phone>05338724271</phone>
        <email>fzt.yasinyurt@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Özge Çiftçi, R.A</last_name>
      </contact_backup>
      <investigator>
        <last_name>Özge Çiftçi, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Cansu Koltak, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tuğba Paksoy, RA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Merve Paksoy, RA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Eastern Mediterranean University</investigator_affiliation>
      <investigator_full_name>Yasin YURT</investigator_full_name>
      <investigator_title>Assoc. Prof. Dr.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data of participants will not be shared individually because of health policy. Results will be shared as an overall data.</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/NCT05999539
  org study id: ETK00-2023-0130
  nct id: NCT05999539
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Researchers aim to compare demographic characteristics, prosthesis type, functional capacity,
        and quality of life between faller and non-faller transtibial amputees.
  Unilateral transtibial level prosthetic users will be included in this study. After getting
        the fall history of subjects, those who feel at least one time or more in the last year will
        be accepted as the faller group. Demographic characteristics, functional capacity,
        health-related quality of life, and prosthetic types used by amputees will be assessed. The
        main differences between the faller and non-faller transtibial amputees will be analyzed with
        the data.
  observational model: Case-Control
  time perspective: Prospective
  measure: Two-minute walk test
  time frame: 1 week
  description: The test to be carried out to find out functional capacity, in a 30-meter-long area will be marked at 3-meter intervals, and the turning points will be determined with an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes and we will tell them that they can slow down and stop when they get tired. When 2 minutes are completed with a stopwatch, we will ask the individual to stop and record the walking distance in meters.
  measure: Functional Reach Test
  time frame: 1 week
  description: This test will be used to assess balance. The subjects will be asked to stand sideways next to the wall and wait with the shoulder in 90 degrees flexion, elbow in extension and fist closed without touching the wall with the arm close to the wall. The 3rd metacarpal head will be marked and the patient will be asked to reach as far as they can without taking a step, then the new location of the 3rd metacarpal head will be marked. Scoring will be determined by measuring the difference between the start and end position in centimeters. 3 attempts will be made and the best result will be taken.
  measure: Timed Up and Go Test
  time frame: 1 week
  description: This test will be used to assess fall risk. A distance of 3 meters will be determined in front of the chair, the individual is asked to get up from the chair and walk the determined distance, and the time elapsed will be recorded with a stopwatch with seconds.
  measure: Trinity Amputation and Prosthesis Experiences Scales
  time frame: 1 week
  description: This test is used to assess different aspects of amputees' experience of prosthesis use and quality of life. It gives a total score that means better when higher.
  arm group label: Faller transtibial prosthetic users
  description: Transtibial prosthetic users who fell at least once in the last year.
  arm group label: Non-faller transtibial prosthetic users
  description: Transtibial prosthetic users who have no fall history.
  intervention type: Device
  intervention name: Transtibial prosthesis
  description: A transtibial prosthesis to be used for at least one year.
  arm group label: Faller transtibial prosthetic users
  arm group label: Non-faller transtibial prosthetic users
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Eastern Mediterranean University
  investigator full name: Yasin YURT
  investigator title: Assoc. Prof. Dr.
  mesh term: Mobility Limitation
  sharing ipd: No
  ipd description: Data of participants will not be shared individually because of health policy. Results will be shared as an overall data.