<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/NCT03271775</url>
  </required_header>
  <id_info>
    <org_study_id>UHaifa2808</org_study_id>
    <nct_id>NCT03271775</nct_id>
  </id_info>
  <brief_title>Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit</brief_title>
  <acronym>VOR</acronym>
  <official_title>Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit - Characteristics of Overt and Covert Saccadic Eye Movements Measured by the Video Head Impulse Test (vHIT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Haifa</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>
      The study is examine the eye movements characteristics of patients with VOR gain deficits&#xD;
      (overt and covert saccades) before and after physical therapy intervention program and&#xD;
      examine the most effective physical therapy treatment program for patients with&#xD;
      vestibulopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vestibular system receives and conveys information about head motion in space, and is the&#xD;
      main human sensory system dedicated to detecting self-motion.The vestibular system plays a&#xD;
      crucial role in static and dynamic balance control, stabilizing the head and trunk,&#xD;
      especially on unstable surfaces . In terms of postural control and falls, the literature&#xD;
      describes a direct association between VOR deficits, gait instability, and falls.The &quot;gain&quot;&#xD;
      of the VOR is defined as the change in the eye angle divided by the change in the head angle&#xD;
      during the head turn. Under ideal conditions, the gain of the rotational VOR is 1.0, meaning&#xD;
      there is a compensatory eye velocity equal to the head velocity and in the opposite&#xD;
      direction. In case of a positive vHIT, the VOR gain is decreased and refixating saccades are&#xD;
      observed. The video Head Impulse Test measures eye velocity during head rotation. Instant&#xD;
      feedback about every single head impulse allows the examiner to apply a set of standardized&#xD;
      graded impulses. The system is easy to use in a clinical setting, provides an objective&#xD;
      measure of the VOR, and detects both overt and covert catch-up saccades in patients with&#xD;
      vestibular loss. Measurements are quick and noninvasive, and the automated analysis software&#xD;
      provides instant results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>After the initial test, subjects will randomly distribute into three different research groups.&#xD;
Each subgroup will include 30 patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)</measure>
    <time_frame>up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy</time_frame>
    <description>The Vhit incorporates a new technology that uses a high speed light weight video goggle to measure high velocity and record &quot;catch up&quot; saccades in patients with impaired VOR function. we will examine the changes from baseline in the latency, frequency and duration of the overt and covert saccadic eye movements. In addition, we would like to examine changes over time in the ratio between the head and the eye movement (Gain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline velocity sway at 3 and 6 months measured by force platform</measure>
    <time_frame>up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy</time_frame>
    <description>The force plate is designed to measure the forces and moments applied to its top surface as a subjects stands, steps, or jumps on it. Force plates are regularly used in research and clinical studies looking at balance, gait, and sports performance (www.amti.biz). Center of pressure (COP) data during the stability tests will be sampled at a frequency of 100 Hz. We will perform the zur balance scale (ZBS) on the plate at each time and evaluate the changes from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire</measure>
    <time_frame>up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy</time_frame>
    <description>The ABC is one of a several tools designed to measure an individual's confidence in her/his ability to perform daily activities without falling.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vestibulopathy, Acute Peripheral</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT treatment group for balance disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this research group will join to a 3 months' physical therapy treatment group designed to improve balance. The service for the group is provided by laboratory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>independant home computerized exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be treated by 3 months' independent home computerized exercise program. Each patient will receive a personal access code for the exercise program. The duration of each practice is 5-10 minutes per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical therapy program (group)</intervention_name>
    <description>Exercises group transmitted by physical therapist (Up to four participant in each group).</description>
    <arm_group_label>PT treatment group for balance disorder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical therapy program (computerized exercises)</intervention_name>
    <description>Remote exercises program accompanied by a physical therapist guidance</description>
    <arm_group_label>independant home computerized exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with unilateral or bilateral vestibulopathy living independently in the&#xD;
             community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive state decline neurological disorder disease or disorders that can affect&#xD;
             balance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmeli Eli, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haifa University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liraz Tencer-Lagziel, MA</last_name>
    <phone>+972-9-7440429</phone>
    <email>liraztencer@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Oz Zur, PHD</last_name>
    <phone>+972-9-7440429</phone>
    <email>zurbalance@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Israeli Center for the Treatment of Dizziness and Imbalance</name>
      <address>
        <city>Ra'anana</city>
        <zip>4330010</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Haifa</investigator_affiliation>
    <investigator_full_name>Carmeli Eli</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Dizziness</keyword>
  <keyword>Instability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibular Neuronitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>the data for all primary and secondary outcome measure will be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>data will be available within 6 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Requestor will be required to sign a data access agreement</ipd_access_criteria>
  </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/NCT03271775
org study id: UHaifa2808
nct id: NCT03271775
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is examine the eye movements characteristics of patients with VOR gain deficits
      (overt and covert saccades) before and after physical therapy intervention program and
      examine the most effective physical therapy treatment program for patients with
      vestibulopathy.
The vestibular system receives and conveys information about head motion in space, and is the
      main human sensory system dedicated to detecting self-motion.The vestibular system plays a
      crucial role in static and dynamic balance control, stabilizing the head and trunk,
      especially on unstable surfaces . In terms of postural control and falls, the literature
      describes a direct association between VOR deficits, gait instability, and falls.The "gain"
      of the VOR is defined as the change in the eye angle divided by the change in the head angle
      during the head turn. Under ideal conditions, the gain of the rotational VOR is 1.0, meaning
      there is a compensatory eye velocity equal to the head velocity and in the opposite
      direction. In case of a positive vHIT, the VOR gain is decreased and refixating saccades are
      observed. The video Head Impulse Test measures eye velocity during head rotation. Instant
      feedback about every single head impulse allows the examiner to apply a set of standardized
      graded impulses. The system is easy to use in a clinical setting, provides an objective
      measure of the VOR, and detects both overt and covert catch-up saccades in patients with
      vestibular loss. Measurements are quick and noninvasive, and the automated analysis software
      provides instant results.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After the initial test, subjects will randomly distribute into three different research groups.
Each subgroup will include 30 patients.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)
time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
description: The Vhit incorporates a new technology that uses a high speed light weight video goggle to measure high velocity and record "catch up" saccades in patients with impaired VOR function. we will examine the changes from baseline in the latency, frequency and duration of the overt and covert saccadic eye movements. In addition, we would like to examine changes over time in the ratio between the head and the eye movement (Gain).
measure: Change from baseline velocity sway at 3 and 6 months measured by force platform
time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
description: The force plate is designed to measure the forces and moments applied to its top surface as a subjects stands, steps, or jumps on it. Force plates are regularly used in research and clinical studies looking at balance, gait, and sports performance (www.amti.biz). Center of pressure (COP) data during the stability tests will be sampled at a frequency of 100 Hz. We will perform the zur balance scale (ZBS) on the plate at each time and evaluate the changes from baseline.
measure: Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire
time frame: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy
description: The ABC is one of a several tools designed to measure an individual's confidence in her/his ability to perform daily activities without falling.
arm group label: control group
arm group type: No Intervention
description: Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.
arm group label: PT treatment group for balance disorder
arm group type: Experimental
description: Patients in this research group will join to a 3 months' physical therapy treatment group designed to improve balance. The service for the group is provided by laboratory.
arm group label: independant home computerized exercises
arm group type: Experimental
description: Patients in this group will be treated by 3 months' independent home computerized exercise program. Each patient will receive a personal access code for the exercise program. The duration of each practice is 5-10 minutes per day.
intervention type: Other
intervention name: physical therapy program (group)
description: Exercises group transmitted by physical therapist (Up to four participant in each group).
arm group label: PT treatment group for balance disorder
intervention type: Other
intervention name: physical therapy program (computerized exercises)
description: Remote exercises program accompanied by a physical therapist guidance
arm group label: independant home computerized exercises
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Carmeli Eli, Prof
role: Principal Investigator
affiliation: Haifa University
last name: Liraz Tencer-Lagziel, MA
phone: +972-9-7440429
email: liraztencer@gmail.com
last name: Oz Zur, PHD
phone: +972-9-7440429
email: zurbalance@gmail.com
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: University of Haifa
investigator full name: Carmeli Eli
investigator title: Prof.
mesh term: Vestibular Neuronitis
sharing ipd: Yes
ipd description: the data for all primary and secondary outcome measure will be available
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: data will be available within 6 months of study completion
ipd access criteria: Requestor will be required to sign a data access agreement