<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/NCT03838562</url>
  </required_header>
  <id_info>
    <org_study_id>7673</org_study_id>
    <nct_id>NCT03838562</nct_id>
  </id_info>
  <brief_title>Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.</brief_title>
  <acronym>EquiRV</acronym>
  <official_title>Non-inferiority of Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes. Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Context and justification: Vertigo leads to medical consultation, interruption of daily&#xD;
      activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and&#xD;
      adaptation exercises. The technology of three-dimensional head-mounted provides a strong&#xD;
      immersion allowing optokinetic stimulation but studies interested in virtual reality in the&#xD;
      context of balance rehabilitation have not been able to highlight the superiority of this&#xD;
      therapy. The investigators therefore propose a non-inferiority trial because of the&#xD;
      affordable price and small size of three-dimensional head-mounted.&#xD;
&#xD;
      Objectives : The objective of this study is to evaluate whether a rehabilitation program&#xD;
      using virtual reality is as effective as a reference program using Smart Equitest and an&#xD;
      optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or&#xD;
      4 weeks of rehabilitation.&#xD;
&#xD;
      The investigators also assess the disability related to vertigo and balance disorders as well&#xD;
      as the tolerance of virtual reality Methodology: Prospective, randomized controlled&#xD;
      non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of&#xD;
      follow-up.&#xD;
&#xD;
      The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program&#xD;
      and the possible standing position.&#xD;
&#xD;
      The criteria for non-inclusion are visually impaired or blind subjects, lack of relief&#xD;
      vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes&#xD;
      and Ménière's disease.&#xD;
&#xD;
      The main evaluation criterion is the balance score obtained with eyes closed on an unstable&#xD;
      plane during a sensory organization test performed on a dynamic posturology platform,&#xD;
      obtained during the final evaluation.&#xD;
&#xD;
      The secondary judgment criteria are:&#xD;
&#xD;
        -  The balance scores obtained in the sensory organization test under other conditions.&#xD;
&#xD;
        -  The Dizziness Handicap Inventory obtained during the final evaluation and three months&#xD;
           after the end of the program.&#xD;
&#xD;
        -  The tolerance of virtual reality will be measured weekly by the Simulator Sickness&#xD;
           Questionnaire.&#xD;
&#xD;
      Statistics: The number of subjects to be included is 76, the analysis will first be performed&#xD;
      per-protocol, the difference in scores between the two groups will be calculated, as well as&#xD;
      its 95% confidence interval. If the lower bound of this interval is above the non-inferiority&#xD;
      threshold, the same analysis will be performed on the population intending to treat (all&#xD;
      randomized patients).&#xD;
&#xD;
      Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of&#xD;
      inclusions is 27 months, The duration of patient participation in the protocol is 4 months.&#xD;
      Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a&#xD;
      week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste&#xD;
      Floret has the human and material resources necessary to carry out the protocol. The PMSI&#xD;
      data show that the department receives about 40 patients per year who are likely to&#xD;
      participate in the protocol.&#xD;
&#xD;
      Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual&#xD;
      reality, this study could provide further evidence of the value of this type of tool for the&#xD;
      rehabilitation of subjects suffering from vestibular disorders. In addition, a&#xD;
      medico-economic study would be possible in order to reinforce the advantages of virtual&#xD;
      reality helmets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 23, 2019</start_date>
  <completion_date type="Anticipated">November 23, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 23, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance score with eyes closed on an unstable plane during a sensory organization test</measure>
    <time_frame>after 3 or 4 weeks of rehabilitation</time_frame>
    <description>Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Others score of the sensory organization test</measure>
    <time_frame>3 or 4 weeks</time_frame>
    <description>Realized with the Framiral® multitest equilibre.Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Dizziness Handicap Inventory</measure>
    <time_frame>3 or 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Dizziness Handicap Inventory</measure>
    <time_frame>4 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Simulator Sickness Questionnaire</measure>
    <time_frame>weekly from week 1 to week 3 or 4</time_frame>
    <description>This questionnaire includes the following questions: &quot;Not at all&quot;, &quot;A little&quot;, &quot;Moderately&quot; and &quot;Severely&quot;, each answer is worth 0, 1, 2 or 3 points. The total score is equal to 48, the two scores are calculable &quot;Nausea&quot; on 27 and &quot;Oculomotor&quot; on 21. The higher the score, the more the side effects are important.l 10 minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Vestibular Syndrome</condition>
  <condition>Optokinetic Stimulation</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular rehabilitation with virtual reality</intervention_name>
    <description>Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.&#xD;
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.&#xD;
Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group.</description>
    <arm_group_label>Virtual Reality Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard optokinetic stimulator or dynamic visual surround</intervention_name>
    <description>Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.&#xD;
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.&#xD;
Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatology related to a vestibular disorder, eligible for a rehabilitation program&#xD;
             Possible standing position&#xD;
&#xD;
          -  Informed subject and having signed the informed consent form&#xD;
&#xD;
          -  Major subject&#xD;
&#xD;
          -  Affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Badly sighted or blind subject (sharpness &lt;1 / 10th)&#xD;
&#xD;
          -  Absence of vision of the reliefs&#xD;
&#xD;
          -  Strabismus important&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  General state strongly altered&#xD;
&#xD;
          -  Pregnant subject&#xD;
&#xD;
          -  Major protected by law&#xD;
&#xD;
          -  Subject deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Isabelle LAFFONT, PUPH</last_name>
    <phone>0467338664</phone>
    <email>i-laffont@chu-montpellier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gaël Le Perf</last_name>
    <phone>0651763239</phone>
    <email>g.leperf@hopital-lamalou.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy</name>
      <address>
        <city>Lamalou-les-Bains</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaël LE PERF</last_name>
      <phone>0651763239</phone>
      <email>leperf@hopital-lamalou.fr</email>
    </contact>
    <investigator>
      <last_name>Gaël LE PERF</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 4, 2023</last_update_submitted>
  <last_update_submitted_qc>March 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>vestibular</keyword>
  <keyword>balance</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibular Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03838562
org study id: 7673
nct id: NCT03838562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Context and justification: Vertigo leads to medical consultation, interruption of daily
      activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and
      adaptation exercises. The technology of three-dimensional head-mounted provides a strong
      immersion allowing optokinetic stimulation but studies interested in virtual reality in the
      context of balance rehabilitation have not been able to highlight the superiority of this
      therapy. The investigators therefore propose a non-inferiority trial because of the
      affordable price and small size of three-dimensional head-mounted.

      Objectives : The objective of this study is to evaluate whether a rehabilitation program
      using virtual reality is as effective as a reference program using Smart Equitest and an
      optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or
      4 weeks of rehabilitation.

      The investigators also assess the disability related to vertigo and balance disorders as well
      as the tolerance of virtual reality Methodology: Prospective, randomized controlled
      non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of
      follow-up.

      The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program
      and the possible standing position.

      The criteria for non-inclusion are visually impaired or blind subjects, lack of relief
      vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes
      and Ménière's disease.

      The main evaluation criterion is the balance score obtained with eyes closed on an unstable
      plane during a sensory organization test performed on a dynamic posturology platform,
      obtained during the final evaluation.

      The secondary judgment criteria are:

        -  The balance scores obtained in the sensory organization test under other conditions.

        -  The Dizziness Handicap Inventory obtained during the final evaluation and three months
           after the end of the program.

        -  The tolerance of virtual reality will be measured weekly by the Simulator Sickness
           Questionnaire.

      Statistics: The number of subjects to be included is 76, the analysis will first be performed
      per-protocol, the difference in scores between the two groups will be calculated, as well as
      its 95% confidence interval. If the lower bound of this interval is above the non-inferiority
      threshold, the same analysis will be performed on the population intending to treat (all
      randomized patients).

      Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of
      inclusions is 27 months, The duration of patient participation in the protocol is 4 months.
      Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a
      week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste
      Floret has the human and material resources necessary to carry out the protocol. The PMSI
      data show that the department receives about 40 patients per year who are likely to
      participate in the protocol.

      Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual
      reality, this study could provide further evidence of the value of this type of tool for the
      rehabilitation of subjects suffering from vestibular disorders. In addition, a
      medico-economic study would be possible in order to reinforce the advantages of virtual
      reality helmets.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Balance score with eyes closed on an unstable plane during a sensory organization test
time frame: after 3 or 4 weeks of rehabilitation
description: Realized with the Framiral® multitest equilibre. Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
measure: Others score of the sensory organization test
time frame: 3 or 4 weeks
description: Realized with the Framiral® multitest equilibre.Framiral multitest equilibre is a posturography platform for performing vestibular assessments and targeted rehabilitation exercises
measure: The Dizziness Handicap Inventory
time frame: 3 or 4 weeks
measure: The Dizziness Handicap Inventory
time frame: 4 month
measure: The Simulator Sickness Questionnaire
time frame: weekly from week 1 to week 3 or 4
description: This questionnaire includes the following questions: "Not at all", "A little", "Moderately" and "Severely", each answer is worth 0, 1, 2 or 3 points. The total score is equal to 48, the two scores are calculable "Nausea" on 27 and "Oculomotor" on 21. The higher the score, the more the side effects are important.l 10 minutes
arm group label: Virtual Reality Arm
arm group type: Experimental
arm group label: Control Arm
arm group type: Active Comparator
intervention type: Other
intervention name: Vestibular rehabilitation with virtual reality
description: Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group.
arm group label: Virtual Reality Arm
intervention type: Other
intervention name: Standard optokinetic stimulator or dynamic visual surround
description: Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle LAFFONT, PUPH
phone: 0467338664
email: i-laffont@chu-montpellier.fr
last name: Gaël Le Perf
phone: 0651763239
email: g.leperf@hopital-lamalou.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Vestibular Diseases
mesh term: Syndrome