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

NCT01698086 | Completed

• 2 other identifiers: 12-1114RG 4710A1/1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Balance; Fatigue; Eye Movement

Keywords

Multiple Sclerosis; Balance; Fatigue; Eye movement

Outcome Measures

Primary Outcomes (1)

• Balance (Dynamic Posturography/Computerized Sensory Organization Test)

  Change in balance from Baseline to 6 weeks and 14 weeks

  6 weeks and 14 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (4)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Wait-listed Control group

NO INTERVENTION

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.

Interventions

Vestibular rehabilitation: balance and eye movement exercises OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus/University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 29386274 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey R Hebert, PhD, PT

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (1)