<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/NCT04404205</url>
  </required_header>
  <id_info>
    <org_study_id>6</org_study_id>
    <nct_id>NCT04404205</nct_id>
  </id_info>
  <brief_title>The Effect of Cochlear Implant on Postural Control</brief_title>
  <official_title>The Effect of Cochlear Implant on Postural Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale 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>
      Some patients are having balance problems after cochlear implant surgery. There are&#xD;
      contradictory reports about the effect of the implant on postural control. While the cochlear&#xD;
      implant is working, an electrical current is continuously stimulating the cochlear nerve&#xD;
      which is in close proximity with vestibular ganglion and nerve. This stimulation may&#xD;
      contribute to vestibular signals to the central system. The aim of the study is to&#xD;
      investigate if this stimulation has any effect on postural control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients who had unilateral cochlear implantation will be included. Postural stability&#xD;
      measurements will be done by the Biodex Balance System. Three preprogrammed main tests and&#xD;
      their 9 subtests will be applied. Postural stability, fall index, sensory integration will be&#xD;
      calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant&#xD;
      on music on(3), and implant off again(4).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Deviation of center of gravity(angle)</measure>
    <time_frame>3-6 months</time_frame>
    <description>Deviation of center of gravity(angle) test assesses a patient's ability to maintain a center of balance. It measures how much the patient's position deviates from center and reports the average deviation as the stability index. Therefore, a low score is more desirable than a high score. Postural stability is a calculated value of difference in center of gravity when the subjects tested eyes open/closed, hard and soft surface test conditions. Postural stability will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postural sway velocity(angle/sec)</measure>
    <time_frame>3-6 months</time_frame>
    <description>A high sway velocity when a patient is attempting to stand motionless suggests a deficit in postural control and assessment for lower extremity strength, proprioception, and vestibular or visual deficiencies. Postural sway velocity will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)</measure>
    <time_frame>3-6 months</time_frame>
    <description>The Clinical Test of Sensory Interaction of Balance (CTSIB) is a standard test for balance assessment on a static surface. The test assesses how well a patient can integrate sensory information to maintain balance. The result of the CTSIB test is the patient's sway index, which represents the mean absolute deviation of the patient's average position during a test. The higher the sway index, the more unsteady the person was during the test. Sensory Integration Test will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Cochlear Implant</condition>
  <arm_group>
    <arm_group_label>Adult patient with cochlear implant</arm_group_label>
    <description>Adult patients who had cochlear implant surgery before will be included. We will call patients from our cochlear implant list.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Postural stability measurements by Biodex Balance System</intervention_name>
    <description>Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).</description>
    <arm_group_label>Adult patient with cochlear implant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had cochlear implantation in our hospital will be invited to join the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had cochlear implant surgery before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral Cochlear implants&#xD;
&#xD;
          -  Neurologic disease&#xD;
&#xD;
          -  Communication problem&#xD;
&#xD;
          -  Additional disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fazıl N Ardıç, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University</name>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 11, 2022</last_update_submitted>
  <last_update_submitted_qc>June 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Fazıl Necdet Ardıç</investigator_full_name>
    <investigator_title>Chief of Department Otolaryngology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be available University depository</ipd_description>
  </patient_data>
  <!-- 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/NCT04404205
org study id: 6
nct id: NCT04404205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Some patients are having balance problems after cochlear implant surgery. There are
      contradictory reports about the effect of the implant on postural control. While the cochlear
      implant is working, an electrical current is continuously stimulating the cochlear nerve
      which is in close proximity with vestibular ganglion and nerve. This stimulation may
      contribute to vestibular signals to the central system. The aim of the study is to
      investigate if this stimulation has any effect on postural control.
Adult patients who had unilateral cochlear implantation will be included. Postural stability
      measurements will be done by the Biodex Balance System. Three preprogrammed main tests and
      their 9 subtests will be applied. Postural stability, fall index, sensory integration will be
      calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant
      on music on(3), and implant off again(4).
observational model: Cohort
time perspective: Cross-Sectional
measure: Deviation of center of gravity(angle)
time frame: 3-6 months
description: Deviation of center of gravity(angle) test assesses a patient's ability to maintain a center of balance. It measures how much the patient's position deviates from center and reports the average deviation as the stability index. Therefore, a low score is more desirable than a high score. Postural stability is a calculated value of difference in center of gravity when the subjects tested eyes open/closed, hard and soft surface test conditions. Postural stability will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again
measure: postural sway velocity(angle/sec)
time frame: 3-6 months
description: A high sway velocity when a patient is attempting to stand motionless suggests a deficit in postural control and assessment for lower extremity strength, proprioception, and vestibular or visual deficiencies. Postural sway velocity will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again
measure: Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)
time frame: 3-6 months
description: The Clinical Test of Sensory Interaction of Balance (CTSIB) is a standard test for balance assessment on a static surface. The test assesses how well a patient can integrate sensory information to maintain balance. The result of the CTSIB test is the patient's sway index, which represents the mean absolute deviation of the patient's average position during a test. The higher the sway index, the more unsteady the person was during the test. Sensory Integration Test will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again
arm group label: Adult patient with cochlear implant
description: Adult patients who had cochlear implant surgery before will be included. We will call patients from our cochlear implant list.
intervention type: Diagnostic Test
intervention name: Postural stability measurements by Biodex Balance System
description: Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).
arm group label: Adult patient with cochlear implant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Fazıl N Ardıç, MD
role: Principal Investigator
affiliation: Pamukkale University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Fazıl Necdet Ardıç
investigator title: Chief of Department Otolaryngology
sharing ipd: No
ipd description: Data will be available University depository