Terminé

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

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Ce qui est testé

Vestibular rehabilitation: balance and eye movement exercises

Autre
Qui peut participer

Maladies Auto-immunes+7

+ Maladies démyélinisantes

+ Maladies du Système Immunitaire

De 18 à 60 ans
+16 critères d'éligibilité
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Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : octobre 2012
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Résumé

Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 29 janvier 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 octobre 2012

Date à laquelle le premier participant a commencé l'étude.

Hypotheses and Specific Aims Specific Aims Impaired balance (upright postural control), visual instability and fatigue are common complaints in persons with multiple sclerosis (MS), often leading to advanced disability and lower quality of life. MS affects structures throughout the central nervous system (CNS), with frequent involvement of infratentorial structures including the brainstem and cerebellum.1-4 These structures play integral roles in the process of maintaining balance.5-8 Indeed, for the person with MS, involvement of these structures is strongly linked to impaired balance, often leading to falls.9,10 To our knowledge, no studies have established effective treatment to improve balance specifically for persons with MS who have involvement of brainstem/cerebellar structures. Our previous study11 provides evidence that vestibular rehabilitation, an exercise program involving balance and eye movement training, greatly improves balance and fatigue in patients with MS who have primary complaints in these areas. Brainstem and cerebellar dysfunctions are strongly associated with impaired balance.9,10 Analysis from our previous study indicates that greater improvements in balance from vestibular rehabilitation are likely for persons with MS who have brainstem and/or cerebellar involvement. Neural plasticity has been reported in persons with MS following task-specific training.12-15 We conceptualize that vestibular rehabilitation targets the CNS, specifically the brainstem and cerebellum, by providing the necessary task-specific stimuli for effective neural reorganization, improving central sensory integration resulting in improved balance and visual stability. Functioning with impaired balance and visual stability can be highly fatiguing. As such, we anticipate that this intervention approach also improves fatigue. We propose a 16-wk, two-group, stratified-blocked randomized controlled trial. Our primary aim is to determine if vestibular rehabilitation for persons with MS is more effective in improving balance for those who have brainstem and/or cerebellar involvement compared to persons with MS who do not. In addition, because eye movement exercises are an important part of the proposed vestibular rehabilitation program, we will determine if significant changes in visual stability for persons with MS who present with abnormal eye movements are possible following participation in this program. Lastly, we will expand our knowledge of the benefits of vestibular rehabilitation on fatigue Primary Aim: To compare changes in balance based on two strata: participants with brainstem and/or cerebellar involvement and those without, and to compare changes between the two study groups: Experimental group (vestibular rehabilitation program) and Wait-listed Control group (wait-listed for vestibular rehabilitation instruction). Hypothesis (H1): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in balance compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in balance compared to the Wait-listed Control group. Secondary Aim 1: To identify changes in eye movement dysfunction for participants in the Experimental group having eye movement dysfunction at baseline, and to compare changes between the two study groups. Hypothesis (H2): 1) Participants in the Experimental group who present with impaired eye movements at baseline will improve significantly in visual stability following performance in the vestibular rehabilitation program compared to baseline values; 2) Participants in the Experimental group who present with impaired eye movements will improve significantly in visual stability compared to participants in the Wait-listed Control group who also present with impaired eye movements. Secondary Aim 2: To compare changes in self-reported fatigue based on brainstem and/or cerebellar involvement stratum and between the two study groups. Hypothesis (H3): 1) Participants in the Experimental group having brainstem and/or cerebellar involvement will have greater improvements in fatigue compared to those without brainstem and/or cerebellar involvement; 2) The Experimental group will have greater improvements in fatigue compared to the Wait-listed Control group. An overarching objective of our research is to set the stage for future investigations of the underlying mechanisms responsible for the benefits found from vestibular rehabilitation. CNS involvement and neural plasticity will serve as primary targets of future investigations.

NCT01698086
Sponsor principalUniversity of Colorado, Denver
Dernière mise à jour : 29 janvier 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

88 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 60 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies Auto-immunesMaladies démyélinisantesMaladies du Système ImmunitaireMaladies du système nerveuxSignes et symptômesConditions pathologiques, signes et symptômesMaladies auto-immunes du système nerveuxMaladies auto-immunes démyélinisantes, SNCFatigueSclérose en plaques

Critères

8 critères d'inclusion nécessaires pour participer
18 to 60 years of age

able to speak, read and understand English

at least moderate level of impaired balance (SOT composite score < 82)

clinically definite MS confirmed by a neurologist

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8 critères d'exclusion empêchent la participation
complete or legal blindness in one or both eyes

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

medical history of other possible causes of fatigue (e.g. major sleep disorder, clinically diagnosed major depressive disorder, anemia, hypothyroidism, B12 deficiency, cancer)

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Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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.

Groupe II

Pas d'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.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

University of Colorado Anschutz Medical Campus/University of Colorado Denver

Aurora, United StatesOuvrir University of Colorado Anschutz Medical Campus/University of Colorado Denver dans Google Maps
Terminé1 Centres d'Étude