Dataset Information

Rehabilitation to Improve Gaze and Postural Stability in People With Multiple Sclerosis: A Randomized Clinical Trial.

ABSTRACT:

Background

People with multiple sclerosis (PwMS) frequently experience dizziness and imbalance that may be caused by central vestibular system dysfunction. Vestibular rehabilitation may offer an approach for improving dysfunction in these people.

Objective

To test the efficacy of a gaze and postural stability (GPS) retraining intervention compared to a strength and endurance (SAE) intervention in PwMS.

Methods

About 41 PwMS, with complaints of dizziness or history of falls, were randomized to either the GPS or SAE groups. Following randomization participants completed 6-weeks of 3×/week progressive training, delivered one-on-one by a provider. Following intervention, testing was performed at the primary (6-weeks) and secondary time point (10-weeks). A restricted maximum likelihood estimation mixed effects model was used to examine changes in the primary outcome of the Dizziness Handicap Inventory (DHI) between the 2 groups at the primary and secondary time point. Similar models were used to explore secondary outcomes between groups at both timepoints.

Results

Thirty-five people completed the study (17 GPS; 18 SAE). The change in the DHI at the primary time point was not statistically different between the GPS and SAE groups (mean difference = 2.33 [95% CI -9.18, 12.85]). However, both groups demonstrated significant improvement from baseline to 6-weeks (GPS -8.73; SAE -7.31). Similar results were observed for secondary outcomes and at the secondary timepoint.

Conclusions

In this sample of PwMS with complaints of dizziness or imbalance, 6-weeks of GPS training did not result in significantly greater improvements in dizziness handicap or balance compared to 6-weeks of SAE training.

SUBMITTER: Loyd BJ

PROVIDER: S-EPMC10518217 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Rehabilitation to Improve Gaze and Postural Stability in People With Multiple Sclerosis: A Randomized Clinical Trial.

Loyd Brian J BJ Fangman Annie A Peterson Daniel S DS Gappmaier Eduard E Thackeray Anne A Schubert Michael C MC Dibble Leland E LE

Neurorehabilitation and neural repair 20220913 10-11

<h4>Background</h4>People with multiple sclerosis (PwMS) frequently experience dizziness and imbalance that may be caused by central vestibular system dysfunction. Vestibular rehabilitation may offer an approach for improving dysfunction in these people.<h4>Objective</h4>To test the efficacy of a gaze and postural stability (GPS) retraining intervention compared to a strength and endurance (SAE) intervention in PwMS.<h4>Methods</h4>About 41 PwMS, with complaints of dizziness or history of falls, ...[more]

PMID: 36113117

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Project description: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 .

Project description:BACKGROUND:Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques. METHODS:This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI. DISCUSSION:The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages. TRIAL REGISTRATION:The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.

Dataset Information

Rehabilitation to Improve Gaze and Postural Stability in People With Multiple Sclerosis: A Randomized Clinical Trial.

Background

Objective

Methods

Results

Conclusions

Publications

Rehabilitation to Improve Gaze and Postural Stability in People With Multiple Sclerosis: A Randomized Clinical Trial.

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