<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/NCT03832075</url>
  </required_header>
  <id_info>
    <org_study_id>MedeniyetOP2</org_study_id>
    <nct_id>NCT03832075</nct_id>
  </id_info>
  <brief_title>Validity of Korebalance Balance System</brief_title>
  <official_title>Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medeniyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated&#xD;
      with various test and balance systems. This study aims evaluation of the patients with the&#xD;
      Korebalance Balance System and balance tests and investigation the validity of the&#xD;
      Korebalance Balance System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale&#xD;
      (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance&#xD;
      System is a balance assessment and exercise system. The higher the score, the greater the&#xD;
      deterioration in the balance. The results of static and dynamic balance evaluation are&#xD;
      recorded as score values. In this study, investigators compared Korebalance Balance System,&#xD;
      Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical&#xD;
      parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1&#xD;
      year, fracture history, history of fracture in mother).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients</measure>
    <time_frame>6 months</time_frame>
    <description>The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <condition>Balance; Distorted</condition>
  <arm_group>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Berg Balance Scale</intervention_name>
    <description>Berg Balance Scale is 14 item scale for detecting balance disorder.</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Timed Up and Go Test</intervention_name>
    <description>Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Korebalance Balance System</intervention_name>
    <description>Korebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady &amp; balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user &quot;follows&quot;. Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions.</description>
    <arm_group_label>postmenopausal osteoporosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having postmenopausal osteoporosis&#xD;
&#xD;
          -  No other disease that can cause balance disorder&#xD;
&#xD;
          -  Volunteer participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have a disease that will cause balance disorder,&#xD;
&#xD;
          -  Having understanding problem to prevent communication with the patient,&#xD;
&#xD;
          -  The lack of motor function to the balance device.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Postmenopausal osteoporotic patients</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department</name>
      <address>
        <city>Istanbul</city>
        <zip>34732</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bilinç Doğruöz Karatekin</last_name>
      <phone>+905368308709</phone>
      <email>bilincdogruoz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Bilinç Doğruöz Karatekin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Afitap İçağasıoğlu, MD, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yasemin Yumuşakhuylu, MD, Ass. Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fethullah Bayram, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Şeyhmus Yaşin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Bilinç Doğruöz Karatekin</investigator_full_name>
    <investigator_title>MD, Research Assistant of PMR</investigator_title>
  </responsible_party>
  <keyword>osteoporosis</keyword>
  <keyword>balance</keyword>
  <keyword>berg balance scale</keyword>
  <keyword>korebalance balance system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 4, 2020</submitted>
    <returned>January 14, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03832075
org study id: MedeniyetOP2
nct id: NCT03832075
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated
      with various test and balance systems. This study aims evaluation of the patients with the
      Korebalance Balance System and balance tests and investigation the validity of the
      Korebalance Balance System.
53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale
      (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance
      System is a balance assessment and exercise system. The higher the score, the greater the
      deterioration in the balance. The results of static and dynamic balance evaluation are
      recorded as score values. In this study, investigators compared Korebalance Balance System,
      Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical
      parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1
      year, fracture history, history of fracture in mother).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
time frame: 6 months
description: The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.
arm group label: postmenopausal osteoporosis
arm group type: Experimental
description: Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.
intervention type: Diagnostic Test
intervention name: Berg Balance Scale
description: Berg Balance Scale is 14 item scale for detecting balance disorder.
arm group label: postmenopausal osteoporosis
intervention type: Diagnostic Test
intervention name: Timed Up and Go Test
description: Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.
arm group label: postmenopausal osteoporosis
intervention type: Diagnostic Test
intervention name: Korebalance Balance System
description: Korebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady & balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user "follows". Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions.
arm group label: postmenopausal osteoporosis
criteria: 
gender: Female
gender based: Yes
gender description: Postmenopausal osteoporotic patients
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Bilinç Doğruöz Karatekin
investigator title: MD, Research Assistant of PMR
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
sharing ipd: Undecided
submitted: January 4, 2020
returned: January 14, 2020