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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · National Multiple Sclerosis Society
interventional
88
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2018
Actual (reported)Study Completion
August 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2, 2012
Actual (reported)August 2018
Actual (reported)August 2018
Actual (reported)Balance (Dynamic Posturography/Computerized Sensory Organization Test)
Change in balance from Baseline to 6 weeks and 14 weeks
6 weeks and 14 weeks
Visual Stability (Dynamic Visual Acuity and Gaze Stabilization Test)
6 weeks and 14 weeks
Perceived fatigue (Modified Fatigue Impact Scale)
6 weeks and 14 weeks
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Colorado Anschutz Medical Campus/University of Colorado Denver
Aurora, Colorado, 80045, United States
Hebert JR, Corboy JR, Vollmer T, Forster JE, Schenkman M. Efficacy of Balance and Eye-Movement Exercises for Persons With Multiple Sclerosis (BEEMS). Neurology. 2018 Feb 27;90(9):e797-e807. doi: 10.1212/WNL.0000000000005013. Epub 2018 Jan 31.
Jeffrey R Hebert, PhD, PT
University of Colorado, Denver
First Submitted
September 25, 2012
First Posted
October 2, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2018
Actual (reported)Disability due to dizziness or disequilibrium (Dizziness Handicap Inventory)
6 weeks and 14 weeks
Change in Walk Speed (Timed 25 Foot Walk Test)
6 weeks and 14 weeks
Change in Health Status (SF-36)
6 weeks and 14 weeks
Contact the study team to confirm eligibility.
Study Completion
August 2018
Actual (reported)Last Updated
January 29, 2019
Record last verified: 2019-01
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