Completado

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

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Vestibular rehabilitation: balance and eye movement exercises

Otro
Quiénes están siendo reclutados

Enfermedades Autoinmunes+5

+ Enfermedades Desmielinizantes

+ Enfermedades del sistema inmunitario

De 18 a 60 años
+16 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: octubre de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Colorado, Denver
Última actualización: 29 de enero de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de octubre de 2012

Fecha en la que se inscribió al primer participante.

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
Patrocinador PrincipalUniversity of Colorado, Denver
Última actualización: 29 de enero de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 88 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 60 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades AutoinmunesEnfermedades DesmielinizantesEnfermedades del sistema inmunitarioEnfermedades del sistema nerviosoSignos y SíntomasCondiciones Patológicas, Signos y SíntomasFatigaEsclerosis Múltiple

Criterios

8 criterios de inclusión requeridos para participar
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

Mostrar Más Criterios

8 criterios de exclusión impiden participar
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)

Mostrar Más Criterios

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

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.

Grupo II

Sin Intervención
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.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

University of Colorado Anschutz Medical Campus/University of Colorado Denver

Aurora, United StatesAbrir University of Colorado Anschutz Medical Campus/University of Colorado Denver en Google Maps
Completado1 Centros de Estudio