Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)
|ClinicalTrials.gov Identifier: NCT01698086|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2012
Last Update Posted : January 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Balance Fatigue Eye Movement||Other: Vestibular rehabilitation: balance and eye movement exercises||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most?|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Experimental group
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.
Other: Vestibular rehabilitation: balance and eye movement exercises
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.
No Intervention: Wait-listed Control group
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.
- Balance (Dynamic Posturography/Computerized Sensory Organization Test) [ Time Frame: 6 weeks and 14 weeks ]Change in balance from Baseline to 6 weeks and 14 weeks
- Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Visual Stability at 6 weeks 14 weeks
- Perceived fatigue (Modified Fatigue Impact Scale) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Perceived fatigue at 6 weeks 14 weeks.
- Disability due to dizziness or disequilibrium (Dizziness Handicap Inventory) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Disability due to dizziness or disequilibrium at 6 weeks 14 weeks.
- Change in Walk Speed (Timed 25 Foot Walk Test) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Walk Speed at 6 weeks and at 14 weeks.
- Change in Health Status (SF-36) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Health Status at 6 weeks and at 14 weeks.
- Cognition (Perceived Deficits Questionnaire) [ Time Frame: 6 weeks and 14 weeks ]Change from Baseline in Cognition at 6 weeks and 14 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698086
|United States, Colorado|
|University of Colorado Anschutz Medical Campus/University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Jeffrey R Hebert, PhD, PT||University of Colorado, Denver|