<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/NCT01698086</url>
  </required_header>
  <id_info>
    <org_study_id>12-1114</org_study_id>
    <secondary_id>RG 4710A1/1</secondary_id>
    <nct_id>NCT01698086</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)</brief_title>
  <official_title>Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impaired standing balance, fatigue and abnormal eye movements are common problems in persons&#xD;
      with MS. These complaints are related to advanced disability and decreased quality of life&#xD;
      for persons with MS. Researchers from the University of Colorado and the Rocky Mountain&#xD;
      Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and&#xD;
      published a research study that showed an exercise program consisting of balance and eye&#xD;
      movement training, referred to as a vestibular rehabilitation program, was very effective in&#xD;
      improving self-reported fatigue and standing balance in persons with MS. This initial study&#xD;
      was the first to have proven that this type of exercise program is able to improve both of&#xD;
      these potentially devastating complaints.&#xD;
&#xD;
      The investigators from this initial study have partnered with other well-established&#xD;
      researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain&#xD;
      Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of&#xD;
      the effect of vestibular rehabilitation for persons with MS. Using the findings from the&#xD;
      initial study, the investigators propose to conduct a larger study specifically identifying&#xD;
      persons with MS who have brain lesion involvement in areas that control balance and eye&#xD;
      movements. Primarily, the current study will determine if those individuals who have&#xD;
      involvement in these areas of the brain improve more in balance and fatigue compared to those&#xD;
      who do not following participation in a vestibular rehabilitation program. Additionally, the&#xD;
      investigators will test if study participants who have abnormal eye movement control, will&#xD;
      improve their eye movement control following the training program. For persons with MS,&#xD;
      impaired eye movements can lead to a considerable decline in health status, further&#xD;
      illustrating the importance of the research plan to study this important factor.&#xD;
&#xD;
      The investigators believe that greater improvements in balance and fatigue are possible from&#xD;
      a longer treatment, and that participants who have brain lesion involvement in areas that&#xD;
      help control balance and eye movements will benefit greater than those who do not. This&#xD;
      information is important to determine who is more likely to benefit from a vestibular&#xD;
      rehabilitation program. Additionally, the researchers will be able to measure changes in eye&#xD;
      movement control, providing valuable insight into the reasons for the program's&#xD;
      effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses and Specific Aims&#xD;
&#xD;
      Specific Aims Impaired balance (upright postural control), visual instability and fatigue are&#xD;
      common complaints in persons with multiple sclerosis (MS), often leading to advanced&#xD;
      disability and lower quality of life. MS affects structures throughout the central nervous&#xD;
      system (CNS), with frequent involvement of infratentorial structures including the brainstem&#xD;
      and cerebellum.1-4 These structures play integral roles in the process of maintaining&#xD;
      balance.5-8 Indeed, for the person with MS, involvement of these structures is strongly&#xD;
      linked to impaired balance, often leading to falls.9,10 To our knowledge, no studies have&#xD;
      established effective treatment to improve balance specifically for persons with MS who have&#xD;
      involvement of brainstem/cerebellar structures.&#xD;
&#xD;
      Our previous study11 provides evidence that vestibular rehabilitation, an exercise program&#xD;
      involving balance and eye movement training, greatly improves balance and fatigue in patients&#xD;
      with MS who have primary complaints in these areas. Brainstem and cerebellar dysfunctions are&#xD;
      strongly associated with impaired balance.9,10 Analysis from our previous study indicates&#xD;
      that greater improvements in balance from vestibular rehabilitation are likely for persons&#xD;
      with MS who have brainstem and/or cerebellar involvement. Neural plasticity has been reported&#xD;
      in persons with MS following task-specific training.12-15 We conceptualize that vestibular&#xD;
      rehabilitation targets the CNS, specifically the brainstem and cerebellum, by providing the&#xD;
      necessary task-specific stimuli for effective neural reorganization, improving central&#xD;
      sensory integration resulting in improved balance and visual stability. Functioning with&#xD;
      impaired balance and visual stability can be highly fatiguing. As such, we anticipate that&#xD;
      this intervention approach also improves fatigue.&#xD;
&#xD;
      We propose a 16-wk, two-group, stratified-blocked randomized controlled trial. Our primary&#xD;
      aim is to determine if vestibular rehabilitation for persons with MS is more effective in&#xD;
      improving balance for those who have brainstem and/or cerebellar involvement compared to&#xD;
      persons with MS who do not. In addition, because eye movement exercises are an important part&#xD;
      of the proposed vestibular rehabilitation program, we will determine if significant changes&#xD;
      in visual stability for persons with MS who present with abnormal eye movements are possible&#xD;
      following participation in this program. Lastly, we will expand our knowledge of the benefits&#xD;
      of vestibular rehabilitation on fatigue&#xD;
&#xD;
      Primary Aim: To compare changes in balance based on two strata: participants with brainstem&#xD;
      and/or cerebellar involvement and those without, and to compare changes between the two study&#xD;
      groups: Experimental group (vestibular rehabilitation program) and Wait-listed Control group&#xD;
      (wait-listed for vestibular rehabilitation instruction).&#xD;
&#xD;
      Hypothesis (H1): 1) Participants in the Experimental group having brainstem and/or cerebellar&#xD;
      involvement will have greater improvements in balance compared to those without brainstem&#xD;
      and/or cerebellar involvement; 2) The Experimental group will have greater improvements in&#xD;
      balance compared to the Wait-listed Control group.&#xD;
&#xD;
      Secondary Aim 1: To identify changes in eye movement dysfunction for participants in the&#xD;
      Experimental group having eye movement dysfunction at baseline, and to compare changes&#xD;
      between the two study groups.&#xD;
&#xD;
      Hypothesis (H2): 1) Participants in the Experimental group who present with impaired eye&#xD;
      movements at baseline will improve significantly in visual stability following performance in&#xD;
      the vestibular rehabilitation program compared to baseline values; 2) Participants in the&#xD;
      Experimental group who present with impaired eye movements will improve significantly in&#xD;
      visual stability compared to participants in the Wait-listed Control group who also present&#xD;
      with impaired eye movements.&#xD;
&#xD;
      Secondary Aim 2: To compare changes in self-reported fatigue based on brainstem and/or&#xD;
      cerebellar involvement stratum and between the two study groups.&#xD;
&#xD;
      Hypothesis (H3): 1) Participants in the Experimental group having brainstem and/or cerebellar&#xD;
      involvement will have greater improvements in fatigue compared to those without brainstem&#xD;
      and/or cerebellar involvement; 2) The Experimental group will have greater improvements in&#xD;
      fatigue compared to the Wait-listed Control group.&#xD;
&#xD;
      An overarching objective of our research is to set the stage for future investigations of the&#xD;
      underlying mechanisms responsible for the benefits found from vestibular rehabilitation. CNS&#xD;
      involvement and neural plasticity will serve as primary targets of future investigations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance (Dynamic Posturography/Computerized Sensory Organization Test)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change in balance from Baseline to 6 weeks and 14 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Visual Stability at 6 weeks 14 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived fatigue (Modified Fatigue Impact Scale)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Perceived fatigue at 6 weeks 14 weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Disability due to dizziness or disequilibrium (Dizziness Handicap Inventory)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Disability due to dizziness or disequilibrium at 6 weeks 14 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Walk Speed (Timed 25 Foot Walk Test)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Walk Speed at 6 weeks and at 14 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Health Status (SF-36)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Health Status at 6 weeks and at 14 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognition (Perceived Deficits Questionnaire)</measure>
    <time_frame>6 weeks and 14 weeks</time_frame>
    <description>Change from Baseline in Cognition at 6 weeks and 14 weeks.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Balance</condition>
  <condition>Fatigue</condition>
  <condition>Eye Movement</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are randomized to the Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions (Figure 1). The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-listed Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Wait-listed Control group will not receive treatment; however, participants in the Wait-listed Control group will undergo the same outcome measurement plan as the Experimental group. If interested, participants from this group will be placed on a wait-list and will have the opportunity to receive instructions in how to perform the vestibular rehabilitation program following their completion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular rehabilitation: balance and eye movement exercises</intervention_name>
    <description>The Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions. The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. The balance training includes standing and walking tasks on varied types of compliant surfaces, base of support, head movements, visual input and eye-hand tasks. The tasks will progress from simple to more complex. Eye movement exercises will include voluntary saccadic eye movements and smooth pursuit movements. Vestibulo-ocular eye training will be performed while visually fixating on a stationary object, while moving the head up and down and side to side at various speeds, progressing from sitting to standing on firm and compliant surface. Participants in the Experimental group will be given items of the exercise program to perform as a home exercise program.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically definite MS confirmed by a neurologist&#xD;
&#xD;
          -  walk 100 meters with no greater than intermittent or unilateral constant assistive&#xD;
             device support (coinciding with a Kurtzke Expanded Disability Status Scale (EDSS)&#xD;
             range of 1.0 to 6.0: 1.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5&#xD;
             impaired ambulatory status without assistive device; 6.0 impaired ambulatory status&#xD;
             with intermittent or unilateral constant assistive)&#xD;
&#xD;
          -  18 to 60 years of age&#xD;
&#xD;
          -  able to speak, read and understand English&#xD;
&#xD;
          -  provide informed consent&#xD;
&#xD;
          -  report at least a moderate level of fatigue (MFIS total score &gt; 22)&#xD;
&#xD;
          -  at least moderate level of impaired balance (SOT composite score &lt; 82)&#xD;
&#xD;
          -  minimal leg spasticity: score of &lt;1 for the legs on the Modified Ashworth spasticity&#xD;
             scale (score range: 0 - 4; 0 indicates no spasticity present, 4 is legs are rigid in&#xD;
             all directions; 1 = indicates slight increased muscle tone)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-ambulatory&#xD;
&#xD;
          -  use of unilateral or bilateral foot, ankle and/or knee orthoses.&#xD;
&#xD;
          -  medical history of other possible causes of fatigue (e.g. major sleep disorder,&#xD;
             clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12&#xD;
             deficiency, cancer)&#xD;
&#xD;
          -  complete or legal blindness in one or both eyes.&#xD;
&#xD;
          -  neurological disorder which might contribute to significant balance problems, such as&#xD;
             cerebral vascular accident, peripheral neuropathy (including diabetes mellitus),&#xD;
             peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign&#xD;
             positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)&#xD;
&#xD;
          -  documented MS-related exacerbation in the last three months.&#xD;
&#xD;
          -  medical diagnosis or condition (e.g. cardiac, pulmonary, hepatic) that is considered&#xD;
             to be an absolute or relative contraindication to participating in exercise&#xD;
&#xD;
          -  participation in an exercise routine specifically designed to improve balance, fatigue&#xD;
             and/or visual stability within 12 weeks prior to study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey R Hebert, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus/University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Balance</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Eye movement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</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/NCT01698086
org study id: 12-1114
secondary id: RG 4710A1/1
nct id: NCT01698086
lead sponsor: 
collaborator: 
has dmc: No
Impaired standing balance, fatigue and abnormal eye movements are common problems in persons
      with MS. These complaints are related to advanced disability and decreased quality of life
      for persons with MS. Researchers from the University of Colorado and the Rocky Mountain
      Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and
      published a research study that showed an exercise program consisting of balance and eye
      movement training, referred to as a vestibular rehabilitation program, was very effective in
      improving self-reported fatigue and standing balance in persons with MS. This initial study
      was the first to have proven that this type of exercise program is able to improve both of
      these potentially devastating complaints.

      The investigators from this initial study have partnered with other well-established
      researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain
      Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of
      the effect of vestibular rehabilitation for persons with MS. Using the findings from the
      initial study, the investigators propose to conduct a larger study specifically identifying
      persons with MS who have brain lesion involvement in areas that control balance and eye
      movements. Primarily, the current study will determine if those individuals who have
      involvement in these areas of the brain improve more in balance and fatigue compared to those
      who do not following participation in a vestibular rehabilitation program. Additionally, the
      investigators will test if study participants who have abnormal eye movement control, will
      improve their eye movement control following the training program. For persons with MS,
      impaired eye movements can lead to a considerable decline in health status, further
      illustrating the importance of the research plan to study this important factor.

      The investigators believe that greater improvements in balance and fatigue are possible from
      a longer treatment, and that participants who have brain lesion involvement in areas that
      help control balance and eye movements will benefit greater than those who do not. This
      information is important to determine who is more likely to benefit from a vestibular
      rehabilitation program. Additionally, the researchers will be able to measure changes in eye
      movement control, providing valuable insight into the reasons for the program's
      effectiveness.
Hypotheses and Specific Aims

      Specific Aims Impaired balance (upright postural control), visual instability and fatigue are
      common complaints in persons with multiple sclerosis (MS), often leading to advanced
      disability and lower quality of life. MS affects structures throughout the central nervous
      system (CNS), with frequent involvement of infratentorial structures including the brainstem
      and cerebellum.1-4 These structures play integral roles in the process of maintaining
      balance.5-8 Indeed, for the person with MS, involvement of these structures is strongly
      linked to impaired balance, often leading to falls.9,10 To our knowledge, no studies have
      established effective treatment to improve balance specifically for persons with MS who have
      involvement of brainstem/cerebellar structures.

      Our previous study11 provides evidence that vestibular rehabilitation, an exercise program
      involving balance and eye movement training, greatly improves balance and fatigue in patients
      with MS who have primary complaints in these areas. Brainstem and cerebellar dysfunctions are
      strongly associated with impaired balance.9,10 Analysis from our previous study indicates
      that greater improvements in balance from vestibular rehabilitation are likely for persons
      with MS who have brainstem and/or cerebellar involvement. Neural plasticity has been reported
      in persons with MS following task-specific training.12-15 We conceptualize that vestibular
      rehabilitation targets the CNS, specifically the brainstem and cerebellum, by providing the
      necessary task-specific stimuli for effective neural reorganization, improving central
      sensory integration resulting in improved balance and visual stability. Functioning with
      impaired balance and visual stability can be highly fatiguing. As such, we anticipate that
      this intervention approach also improves fatigue.

      We propose a 16-wk, two-group, stratified-blocked randomized controlled trial. Our primary
      aim is to determine if vestibular rehabilitation for persons with MS is more effective in
      improving balance for those who have brainstem and/or cerebellar involvement compared to
      persons with MS who do not. In addition, because eye movement exercises are an important part
      of the proposed vestibular rehabilitation program, we will determine if significant changes
      in visual stability for persons with MS who present with abnormal eye movements are possible
      following participation in this program. Lastly, we will expand our knowledge of the benefits
      of vestibular rehabilitation on fatigue

      Primary Aim: To compare changes in balance based on two strata: participants with brainstem
      and/or cerebellar involvement and those without, and to compare changes between the two study
      groups: Experimental group (vestibular rehabilitation program) and Wait-listed Control group
      (wait-listed for vestibular rehabilitation instruction).

      Hypothesis (H1): 1) Participants in the Experimental group having brainstem and/or cerebellar
      involvement will have greater improvements in balance compared to those without brainstem
      and/or cerebellar involvement; 2) The Experimental group will have greater improvements in
      balance compared to the Wait-listed Control group.

      Secondary Aim 1: To identify changes in eye movement dysfunction for participants in the
      Experimental group having eye movement dysfunction at baseline, and to compare changes
      between the two study groups.

      Hypothesis (H2): 1) Participants in the Experimental group who present with impaired eye
      movements at baseline will improve significantly in visual stability following performance in
      the vestibular rehabilitation program compared to baseline values; 2) Participants in the
      Experimental group who present with impaired eye movements will improve significantly in
      visual stability compared to participants in the Wait-listed Control group who also present
      with impaired eye movements.

      Secondary Aim 2: To compare changes in self-reported fatigue based on brainstem and/or
      cerebellar involvement stratum and between the two study groups.

      Hypothesis (H3): 1) Participants in the Experimental group having brainstem and/or cerebellar
      involvement will have greater improvements in fatigue compared to those without brainstem
      and/or cerebellar involvement; 2) The Experimental group will have greater improvements in
      fatigue compared to the Wait-listed Control group.

      An overarching objective of our research is to set the stage for future investigations of the
      underlying mechanisms responsible for the benefits found from vestibular rehabilitation. CNS
      involvement and neural plasticity will serve as primary targets of future investigations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Balance (Dynamic Posturography/Computerized Sensory Organization Test)
time frame: 6 weeks and 14 weeks
description: Change in balance from Baseline to 6 weeks and 14 weeks
measure: Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Visual Stability at 6 weeks 14 weeks
measure: Perceived fatigue (Modified Fatigue Impact Scale)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Perceived fatigue at 6 weeks 14 weeks.
measure: Disability due to dizziness or disequilibrium (Dizziness Handicap Inventory)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Disability due to dizziness or disequilibrium at 6 weeks 14 weeks.
measure: Change in Walk Speed (Timed 25 Foot Walk Test)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Walk Speed at 6 weeks and at 14 weeks.
measure: Change in Health Status (SF-36)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Health Status at 6 weeks and at 14 weeks.
measure: Cognition (Perceived Deficits Questionnaire)
time frame: 6 weeks and 14 weeks
description: Change from Baseline in Cognition at 6 weeks and 14 weeks.
arm group label: Experimental group
arm group type: Experimental
description: Participants who are randomized to the Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions (Figure 1). The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report.
arm group label: Wait-listed Control group
arm group type: No Intervention
description: The Wait-listed Control group will not receive treatment; however, participants in the Wait-listed Control group will undergo the same outcome measurement plan as the Experimental group. If interested, participants from this group will be placed on a wait-list and will have the opportunity to receive instructions in how to perform the vestibular rehabilitation program following their completion of the study.
intervention type: Other
intervention name: Vestibular rehabilitation: balance and eye movement exercises
description: The Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions. The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. The balance training includes standing and walking tasks on varied types of compliant surfaces, base of support, head movements, visual input and eye-hand tasks. The tasks will progress from simple to more complex. Eye movement exercises will include voluntary saccadic eye movements and smooth pursuit movements. Vestibulo-ocular eye training will be performed while visually fixating on a stationary object, while moving the head up and down and side to side at various speeds, progressing from sitting to standing on firm and compliant surface. Participants in the Experimental group will be given items of the exercise program to perform as a home exercise program.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jeffrey R Hebert, PhD, PT
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue