<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/NCT04497025</url>
  </required_header>
  <id_info>
    <org_study_id>RVEM2020</org_study_id>
    <nct_id>NCT04497025</nct_id>
  </id_info>
  <brief_title>Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis</brief_title>
  <official_title>Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Jesus Casuso-Holgado</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Seville</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>
      The effectiveness of convectional vestibular training for balance and dizziness&#xD;
      rehabilitation in people with multiple sclerosis has been recently demonstrated in a&#xD;
      meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive&#xD;
      virtual reality-based environments seem to be useful for balance and gait rehabilitation in&#xD;
      this population (doi: 10.1177/0269215518768084). However, nothing is known about the&#xD;
      feasibility and effectiveness of immersive virtual reality-based rehabilitation in people&#xD;
      with multiple sclerosis.&#xD;
&#xD;
      The primary aim of this research is to determine the feasibility, safety and effectiveness of&#xD;
      an immersive virtual reality-based vestibular training for dizziness, balance and fatigue&#xD;
      rehabilitation, compared to conventional vestibular training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Feasibility of virtual reality-based vestibular rehabilitation</measure>
    <time_frame>7 weeks of intervention</time_frame>
    <description>Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability&#xD;
Participation rate&#xD;
Retention rate&#xD;
Adherence to treatment rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of virtual reality-based vestibular rehabilitation</measure>
    <time_frame>7 weeks of intervention</time_frame>
    <description>Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem&#xD;
Falls registry&#xD;
Adverse events registry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline dizziness symptoms at 7 weeks</measure>
    <time_frame>7 weeks after intervention</time_frame>
    <description>Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline static balance at 7 weeks</measure>
    <time_frame>7 weeks after intervention</time_frame>
    <description>Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline fatigue at 7 weeks</measure>
    <time_frame>7 weeks after intervention</time_frame>
    <description>Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline quality of life at 7 weeks</measure>
    <time_frame>7 weeks after intervention</time_frame>
    <description>Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Vestibular Disease</condition>
  <condition>Dizziness</condition>
  <condition>Balance Disorders</condition>
  <condition>Fatigue</condition>
  <condition>Quality of Life</condition>
  <condition>Usability</condition>
  <condition>Cybersickness</condition>
  <arm_group>
    <arm_group_label>Immersive virtual reality-based vestibular training.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system.&#xD;
Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk.&#xD;
Same location, tailoring parameters and physical therapist supervision than conventional vestibular training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional vestibular training.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional &quot;Cawthorne-Cooksey&quot; vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention.&#xD;
A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immersive Virtual-based vestibular rehabilitation</intervention_name>
    <description>Vestibular rehabilitation based on virtual environment using a head mounted display</description>
    <arm_group_label>Immersive virtual reality-based vestibular training.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional vestibular rehabilitation protocol</intervention_name>
    <description>&quot;Cawthorne-Cooksey&quot; vestibular rehabilitation exercises.</description>
    <arm_group_label>Conventional vestibular training.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female subjects from 18-65 years old&#xD;
&#xD;
          -  Clinically diagnosed with any type of multiple sclerosis in accordance with the&#xD;
             revised McDonald criteria&#xD;
&#xD;
          -  With walking ability according to the Expanded Disability Status Scale score (EDSS =6)&#xD;
&#xD;
          -  With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blurred vision&#xD;
&#xD;
          -  Cognitive impairment (Mini Mental State Examination =24)&#xD;
&#xD;
          -  Another neurologic disorder contributing to balance impairment&#xD;
&#xD;
          -  Relapse within the last 3 months&#xD;
&#xD;
          -  Changes in pharmacotherapy within the last 3 months&#xD;
&#xD;
          -  History of vestibular rehabilitation within the last 6 months&#xD;
&#xD;
          -  Acute cardiovascular of respiratory illness&#xD;
&#xD;
          -  Any other contraindication to physical activity&#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>Maria Jesus Casuso-Holgado</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Seville</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Jesus Casuso-Holgado</last_name>
    <phone>+34659213135</phone>
    <email>mcasuso@us.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad de Sevilla</name>
      <address>
        <city>Sevilla</city>
        <zip>41004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Maria Jesus Casuso-Holgado</last_name>
      <phone>+34659213135</phone>
      <email>mcasuso@us.es</email>
    </contact>
    <investigator>
      <last_name>Maria Jesus Casuso-Holgado</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cristina Garcia-Muñoz</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Dolores Cortes-Vega</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Seville</investigator_affiliation>
    <investigator_full_name>Maria Jesus Casuso-Holgado</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Vestibular Diseases</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04497025
org study id: RVEM2020
nct id: NCT04497025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effectiveness of convectional vestibular training for balance and dizziness
      rehabilitation in people with multiple sclerosis has been recently demonstrated in a
      meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive
      virtual reality-based environments seem to be useful for balance and gait rehabilitation in
      this population (doi: 10.1177/0269215518768084). However, nothing is known about the
      feasibility and effectiveness of immersive virtual reality-based rehabilitation in people
      with multiple sclerosis.

      The primary aim of this research is to determine the feasibility, safety and effectiveness of
      an immersive virtual reality-based vestibular training for dizziness, balance and fatigue
      rehabilitation, compared to conventional vestibular training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility of virtual reality-based vestibular rehabilitation
time frame: 7 weeks of intervention
description: Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability
Participation rate
Retention rate
Adherence to treatment rate
measure: Safety of virtual reality-based vestibular rehabilitation
time frame: 7 weeks of intervention
description: Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem
Falls registry
Adverse events registry
measure: Change from baseline dizziness symptoms at 7 weeks
time frame: 7 weeks after intervention
description: Dizziness Handicap Inventory (0-100 points). Higher scores mean worse dizziness symptoms.
measure: Change from baseline static balance at 7 weeks
time frame: 7 weeks after intervention
description: Static balance assessed by posturography Dynamic balance assessed by Balance Berg Scale. Higher score better balance.
measure: Change from baseline fatigue at 7 weeks
time frame: 7 weeks after intervention
description: Modified Fatigue Impact Scale (0-84 points). Higher scores mean worse fatigue symptoms.
measure: Change from baseline quality of life at 7 weeks
time frame: 7 weeks after intervention
description: Multiple Sclerosis Quality of Life Scale 54 (0-100 points). Higher values indicate better quality of life.
arm group label: Immersive virtual reality-based vestibular training.
arm group type: Experimental
description: Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system.
Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk.
Same location, tailoring parameters and physical therapist supervision than conventional vestibular training.
arm group label: Conventional vestibular training.
arm group type: Active Comparator
description: Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional "Cawthorne-Cooksey" vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention.
A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).
intervention type: Other
intervention name: Immersive Virtual-based vestibular rehabilitation
description: Vestibular rehabilitation based on virtual environment using a head mounted display
arm group label: Immersive virtual reality-based vestibular training.
intervention type: Other
intervention name: Conventional vestibular rehabilitation protocol
description: "Cawthorne-Cooksey" vestibular rehabilitation exercises.
arm group label: Conventional vestibular training.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Maria Jesus Casuso-Holgado
role: Principal Investigator
affiliation: University of Seville
last name: Maria Jesus Casuso-Holgado
phone: +34659213135
email: mcasuso@us.es
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: University of Seville
investigator full name: Maria Jesus Casuso-Holgado
investigator title: Assistant Professor
mesh term: Vertigo
mesh term: Vestibular Diseases
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue
mesh term: Dizziness
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)