Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)
Condition: Multiple Sclerosis; Balance; Fatigue; Eye Movement
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Vestibular rehabilitation: balance and eye movement exercises
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Balance; Fatigue; Eye movement