Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial)

Completed · Not applicable

Conditions studied: Multiple Sclerosis, Balance, Fatigue, Eye Movement

In brief

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.

Key facts

Study ID

NCT01698086

Run by

University of Colorado, Denver

People needed

88

Starts

2012-10-01

Expected to finish

2018-08-01

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinically definite MS confirmed by a neurologist
• walk 100 meters with no greater than intermittent or unilateral constant assistive device support (coinciding with a Kurtzke Expanded Disability Status Scale (EDSS) range of 1.0 to 6.0: 1.0 to 4.5 fully ambulatory without assistive device; 5.0 to 5.5 impaired ambulatory status without assistive device; 6.0 impaired ambulatory status with intermittent or unilateral constant assistive)
• 18 to 60 years of age
• able to speak, read and understand English
• provide informed consent
• report at least a moderate level of fatigue (MFIS total score > 22)
• at least moderate level of impaired balance (SOT composite score < 82)
• minimal leg spasticity: score of <1 for the legs on the Modified Ashworth spasticity scale (score range: 0 - 4; 0 indicates no spasticity present, 4 is legs are rigid in all directions; 1 = indicates slight increased muscle tone)

You may not qualify if…

• non-ambulatory
• use of unilateral or bilateral foot, ankle and/or knee orthoses.
• medical history of other possible causes of fatigue (e.g. major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer)
• complete or legal blindness in one or both eyes.
• neurological disorder which might contribute to significant balance problems, such as cerebral vascular accident, peripheral neuropathy (including diabetes mellitus), peripheral vestibular disorders (unilateral/bilateral vestibular hypofunction: benign positional paroxysmal vertigo, Meniere's disease, acoustic neuroma)
• documented MS-related exacerbation in the last three months.
• medical diagnosis or condition (e.g. cardiac, pulmonary, hepatic) that is considered to be an absolute or relative contraindication to participating in exercise
• participation in an exercise routine specifically designed to improve balance, fatigue and/or visual stability within 12 weeks prior to study participation

Where it is running

• University of Colorado Anschutz Medical Campus/University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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