Abstract
BackgroundThe use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation.Methods/designThe study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants.DiscussionThis study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS.Trial registrationClinicalTrials.gov, May 29th 2018, NCT03521557.
Highlights
The use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT)
This study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS
It will build on previous work by examining measures across the World health organization international classification of functioning (ICF) and improve the current evidence base for treating PwMS
Summary
Dizziness and falls are among the most debilitating symptoms reported by people with MS. [5] While a number of studies have attempted to improve balance in people with MS [56, 57] it was not until recently that management of balance and dizziness have been approached using a vestibular rehabilitation perspective [8, 9]. [5] While a number of studies have attempted to improve balance in people with MS [56, 57] it was not until recently that management of balance and dizziness have been approached using a vestibular rehabilitation perspective [8, 9]. We have made it a goal to explore outcomes across the spectrum of disability as defined by the WHO International Classification of Functioning, Disability, and Health This includes outcomes from the domains of Body Structure and Function, Activity, and Participation related to both gaze and postural stability. Abbreviations 6MWT: Six minute walk test; ABC: Activities balance confidence scale; CNS: Central nervous system; DHI: Dizziness handicap inventory; DVA: Dynamic visual acuity; EDSS: Expanded disability status scale; FGA: Functional gait assessment; FSS: Fatigue severity scale; GPS: Gaze and postural stability; IMU: Inertial measurement units; MAR: Missing at random; MFIS: Modified fatigue impact scale; MS: Multiple sclerosis; PNS: Peripheral nervous system; PPMS: Primary progressive multiple sclerosis; PwMS: Persons with multiple sclerosis; RCT: Randomized clinical trial; RRMS: Relapsing remitting multiple sclerosis; SOC: Standard of care; SPMS: Secondary progressive multiple sclerosis; SRMS: Secondary relapsing multiple sclerosis; vHIT: Video head impulse test; VOR: Vestibular ocular reflex; VSR: Vestibulospinal reflex; WHO ICF: World health organization international classification of functioning, disability, and health
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