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/NCT06004505</url>
    </required_header>
    <id_info>
      <org_study_id>begümmaster</org_study_id>
      <nct_id>NCT06004505</nct_id>
    </id_info>
    <brief_title>Effect of Vestibular Rehabilitation on Static Posturography Results</brief_title>
    <official_title>The Effect of Vestibular Rehabilitation on Static Posturography Results in Individuals With Unilateral Vestibular Hypofunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Gelisim University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Gelisim 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>
        Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography&#xD;
        (VNG) were voluntarily included in the study. In addition to Static Posturography test, head&#xD;
        thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes&#xD;
        open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes&#xD;
        open/closed and before vestibular rehabilitation treatment In the initial evaluations, the&#xD;
        Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to&#xD;
        assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity,&#xD;
        vertigo, and fatigue. As a result of the study, it was concluded that vestibular&#xD;
        rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its&#xD;
        effectiveness can be monitored with Static Posturography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were&#xD;
        compared. The vestibular rehabilitation program was changed every two weeks. During the&#xD;
        eight-week period, the patients performed the exercise program 3 times a day with 10&#xD;
        repetitions of each exercise. According to the evaluation results after the treatment, there&#xD;
        was a statistically significant improvement in static posturography, especially in the&#xD;
        modified-CTSIB test. There was a statistically significant improvement in dynamic visual&#xD;
        acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes&#xD;
        open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically&#xD;
        significant scores were obtained in VAS and DHI results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 21, 2022</start_date>
    <completion_date type="Actual">January 16, 2023</completion_date>
    <primary_completion_date type="Actual">July 5, 2022</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Static Posturography</measure>
      <time_frame>8 weeks</time_frame>
      <description>In this study, balance assessment was performed using Otometrics ICS Balance Platform Version 7.1.331 Static Posturography device. The patients were asked to take off their shoes and stand on the pressure platform, align themselves at the zero point seen on the computer screen, and stand as still as possible with their hands at their sides. Posturography, Modified Clinical Test of Sensory Interaction Balance (mCTSIB), Limits of Stability (LOS) and Balance Training included in the device are the evaluations made in the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Videonystagmography (VNG)</measure>
      <time_frame>8 weeks</time_frame>
      <description>It captures eye movements related to vestibular dysfunction using a video recorder surrounding the eye. Oculomotor tests are done to determine the ability to move the eye at normal speeds. Abnormal responses indicate central dysfunction. Another component of VNG, caloric test; It is a noninvasive method that allows the evaluation of vestibular function as a result of the creation of current in the endolymph by introducing water or air in the low frequency area directly to the eardrum of both ears.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Posture Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient stretched one foot directly in front of the other for 30 seconds without support and tried to maintain his position without falling. The time was kept with a stopwatch.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Semitandem Posture Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient stretched one foot slightly in front of the other for 30 seconds without support and tried to maintain her/his position without falling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Romberg Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient tried to maintain her position without falling for 30 seconds with her feet together, eyes closed, arms crossed over her/his shoulder.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One Leg Standing Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>The patient was asked to raise one leg while standing. From the moment he lifted his foot, the time began to be kept. The time was kept for 30 seconds. The time was stopped when the patient lowered their foot before 30 seconds. It was applied to both feet with the eye open and closed. Then it was applied on soft ground with eyes open and closed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Head Thrust Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>This test is a simple bedside test aimed at determining the presence of unilateral canal paresis. It is performed by the examiner grasping the patient's head and turning his head to the right and left in a short, small amplitude, high acceleration. Before the movement, the patient is asked to look fixedly at the examiner's nose. If the vestibular system is intact on both sides, the patient's eyes should be facing the target when head thrust is stopped. If there is a decrease in vestibular function during rapid movements, the corrective saccade movement occurs in the eye and the head thrust test is positive.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unterberger Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is an eyes-closed step test for the diagnosis of unilateral vestibular dysfunction. In this study, patients were first asked to count 10 steps with their eyes open to get used to it. Then, he was asked to count 50 steps in place with his hands at his sides and his eyes closed. If the patient turned more than 45 degrees to the right or left, the test was positive (abnormal), and straight progression without turning was considered normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dynamic Visual Acuity Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>In this study, the patient was seated in a chair 3 m away from the Snellen visual chart consisting of 10 lines of letters hanging on the wall. First, the patient was asked where he could read in the table. The letters in the table are reduced from top to bottom. The patient's head was started to be turned to the right and left 1-2 times per second. Meanwhile, the patient began to read the letters in front of him from top to bottom. When he told us the line where the clarity deteriorated and he started to see blurry, the test was terminated and recorded.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Unilateral Vestibular Dysfunction Disease</condition>
    <arm_group>
      <arm_group_label>Vestibular Rehabilitation Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Vestibular rehabilitation program; Gaze consisted of stabilization, adaptation, neck and balance exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vestibular Rehabilitation</intervention_name>
      <description>The patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions.</description>
      <arm_group_label>Vestibular Rehabilitation Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals diagnosed with unilateral vestibular hypofunction by VNG&#xD;
  &#xD;
            -  Individuals aged 18-65&#xD;
  &#xD;
            -  Normal otomicroscopic examination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with neurological disorders&#xD;
  &#xD;
            -  Having physical problems that may interfere with walking&#xD;
  &#xD;
            -  Central finding as a result of the VNG test&#xD;
  &#xD;
            -  Pathology in temporal bone MRI&#xD;
  &#xD;
            -  Having a cognitive impairment that prevents communication&#xD;
  &#xD;
            -  Have a severe visual impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebru SEVER, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Physiotherapy &amp; Rehabilitation</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gamze KILIÇ, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Physiotherapy &amp; Rehabilitation</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kaan Can UYANIK, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Health Management</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cengiz ÇELİKYURT, Assistant Professor/MD</last_name>
      <role>Study Director</role>
      <affiliation>Clinic of Otolaryngology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Güneşli Erdem Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Bağcılar</state>
          <zip>34200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Gelisim University</investigator_affiliation>
      <investigator_full_name>Begum Sultan Akar</investigator_full_name>
      <investigator_title>master</investigator_title>
    </responsible_party>
    <keyword>Unilateral vestibular hypofunction</keyword>
    <keyword>balance</keyword>
    <keyword>static posturography</keyword>
    <keyword>vestibular rehabilitation</keyword>
    <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/NCT06004505
  org study id: begümmaster
  nct id: NCT06004505
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography
        (VNG) were voluntarily included in the study. In addition to Static Posturography test, head
        thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes
        open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes
        open/closed and before vestibular rehabilitation treatment In the initial evaluations, the
        Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to
        assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity,
        vertigo, and fatigue. As a result of the study, it was concluded that vestibular
        rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its
        effectiveness can be monitored with Static Posturography.
  Patients were re-evaluated after 8 weeks of vestibular rehabilitation and the results were
        compared. The vestibular rehabilitation program was changed every two weeks. During the
        eight-week period, the patients performed the exercise program 3 times a day with 10
        repetitions of each exercise. According to the evaluation results after the treatment, there
        was a statistically significant improvement in static posturography, especially in the
        modified-CTSIB test. There was a statistically significant improvement in dynamic visual
        acuity, head thrust test, bucket test, standing on one leg on firm and foam ground with eyes
        open/closed, tandem stance test with eyes closed, and Unterberger test. Statistically
        significant scores were obtained in VAS and DHI results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Static Posturography
  time frame: 8 weeks
  description: In this study, balance assessment was performed using Otometrics ICS Balance Platform Version 7.1.331 Static Posturography device. The patients were asked to take off their shoes and stand on the pressure platform, align themselves at the zero point seen on the computer screen, and stand as still as possible with their hands at their sides. Posturography, Modified Clinical Test of Sensory Interaction Balance (mCTSIB), Limits of Stability (LOS) and Balance Training included in the device are the evaluations made in the study.
  measure: Videonystagmography (VNG)
  time frame: 8 weeks
  description: It captures eye movements related to vestibular dysfunction using a video recorder surrounding the eye. Oculomotor tests are done to determine the ability to move the eye at normal speeds. Abnormal responses indicate central dysfunction. Another component of VNG, caloric test; It is a noninvasive method that allows the evaluation of vestibular function as a result of the creation of current in the endolymph by introducing water or air in the low frequency area directly to the eardrum of both ears.
  measure: Tandem Posture Test
  time frame: 8 weeks
  description: The patient stretched one foot directly in front of the other for 30 seconds without support and tried to maintain his position without falling. The time was kept with a stopwatch.
  measure: Semitandem Posture Test
  time frame: 8 weeks
  description: The patient stretched one foot slightly in front of the other for 30 seconds without support and tried to maintain her/his position without falling.
  measure: Romberg Test
  time frame: 8 weeks
  description: The patient tried to maintain her position without falling for 30 seconds with her feet together, eyes closed, arms crossed over her/his shoulder.
  measure: One Leg Standing Test
  time frame: 8 weeks
  description: The patient was asked to raise one leg while standing. From the moment he lifted his foot, the time began to be kept. The time was kept for 30 seconds. The time was stopped when the patient lowered their foot before 30 seconds. It was applied to both feet with the eye open and closed. Then it was applied on soft ground with eyes open and closed.
  measure: Head Thrust Test
  time frame: 8 weeks
  description: This test is a simple bedside test aimed at determining the presence of unilateral canal paresis. It is performed by the examiner grasping the patient's head and turning his head to the right and left in a short, small amplitude, high acceleration. Before the movement, the patient is asked to look fixedly at the examiner's nose. If the vestibular system is intact on both sides, the patient's eyes should be facing the target when head thrust is stopped. If there is a decrease in vestibular function during rapid movements, the corrective saccade movement occurs in the eye and the head thrust test is positive.
  measure: Unterberger Test
  time frame: 8 weeks
  description: It is an eyes-closed step test for the diagnosis of unilateral vestibular dysfunction. In this study, patients were first asked to count 10 steps with their eyes open to get used to it. Then, he was asked to count 50 steps in place with his hands at his sides and his eyes closed. If the patient turned more than 45 degrees to the right or left, the test was positive (abnormal), and straight progression without turning was considered normal.
  measure: Dynamic Visual Acuity Test
  time frame: 8 weeks
  description: In this study, the patient was seated in a chair 3 m away from the Snellen visual chart consisting of 10 lines of letters hanging on the wall. First, the patient was asked where he could read in the table. The letters in the table are reduced from top to bottom. The patient's head was started to be turned to the right and left 1-2 times per second. Meanwhile, the patient began to read the letters in front of him from top to bottom. When he told us the line where the clarity deteriorated and he started to see blurry, the test was terminated and recorded.
  arm group label: Vestibular Rehabilitation Group
  arm group type: Other
  description: Vestibular rehabilitation program; Gaze consisted of stabilization, adaptation, neck and balance exercises.
  intervention type: Other
  intervention name: Vestibular Rehabilitation
  description: The patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions.
  arm group label: Vestibular Rehabilitation Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ebru SEVER, Lecturer
  role: Principal Investigator
  affiliation: Department of Physiotherapy & Rehabilitation
  last name: Gamze KILIÇ, PHD
  role: Principal Investigator
  affiliation: Department of Physiotherapy & Rehabilitation
  last name: Kaan Can UYANIK, Lecturer
  role: Principal Investigator
  affiliation: Department of Health Management
  last name: Cengiz ÇELİKYURT, Assistant Professor/MD
  role: Study Director
  affiliation: Clinic of Otolaryngology
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Gelisim University
  investigator full name: Begum Sultan Akar
  investigator title: master
  sharing ipd: No