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Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis

5 de abril de 2017 actualizado por: Ruchika Prakash, Ohio State University

Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis

Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with MS. It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS. We will be guided by the following three specific aims and hypotheses:

Specific Aim 1: Determine if an eight-week exercise program administered using DDR improves dynamic balance in people with MS relative to a wait-list control group.

Hypothesis 1: Dynamic balance as measured by the Berg Balance Scale will be more improved with the DDR intervention than the wait-list control group.

Specific Aim 2: Determine if the DDR intervention, combining fitness and cognitive training, over the course of an eight-week intervention, will have a more positive effect on domains of processing speed and executive control, than a wait-list control group.

Hypothesis 2: The DDR group relative to the wait-list control group, will show significant improvement in cognitive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT), a measure of processing speed, and executive functioning. Specifically, we hypothesize that given severe deficits in processing speed and executive control, participation in a DDR intervention, will result in a significant improvement on the PASAT, a widely used measure to assess cognitive functioning in patients with MS.

Specific Aim 3: We will also examine whether improvements in cognitive processes engendered by DDR on the PASAT will be supported by changes in underlying neural circuits, as inferred from patterns of event-related functional magnetic resonance imaging (fMRI) activation obtained in a 3 Tesla scanner.

Hypothesis 3: Improvements in cognition as indexed by higher accuracy scores and faster reaction time on the PASAT, will be accompanied by a change in the recruitment of underlying neural processes as inferred from functional magnetic resonance imaging. MS participants in the DDR group will show an increase in recruitment of the attentional network, and more specifically the prefrontal and parietal cortices, cortical regions responsible for successful performance on the PASAT task.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • The Ohio State University Atwell Hall

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 59 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Expanded Disability Status Score of < 5 and a diagnosis of relapsing-remitting multiple sclerosis

Exclusion Criteria:

  • other neurological or orthopedic diagnosis that limits ambulation, age 30-59

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dance Dance Revolution game play
Dance Dance Revolution video game play
Individuals play dance dance revolution 3 times a week for 8 weeks
Sin intervención: control
individuals continue usual care for 8 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Berg Balance Scale
Periodo de tiempo: after 8 weeks
The Berg Balance scale consists of 14 functional activities that test static and dynamic balance. Each item is scored on a scale of 0-4 with higher scores indicating better balance
after 8 weeks
PASAT
Periodo de tiempo: after 8 weeks
The PASAT is a measure of sustained attention, working memory and information processing speed.
after 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
4 square step test
Periodo de tiempo: after 8 weeks
requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
after 8 weeks
The Activities Specific Balance Confidence Scale
Periodo de tiempo: after 8 weeks
Measures fear of falling. Subjects rate their balance confidence on 10 items.
after 8 weeks
GAITRite
Periodo de tiempo: after 8 weeks
individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
after 8 weeks
6 minute walk test
Periodo de tiempo: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
subjects walk for 6 minutes and distance walked is measured
Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
physical activity
Periodo de tiempo: after 8 weeks
subjects wear an accelerometer for 5 days which records how active they are.
after 8 weeks
multiple sclerosis quality of life inventory
Periodo de tiempo: after 8 weeks
the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
after 8 weeks
fMRI
Periodo de tiempo: after 8 weeks
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
after 8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Ruchika Prakash, PhD, Ohio State University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2011

Finalización primaria (Actual)

1 de agosto de 2015

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

29 de enero de 2013

Publicado por primera vez (Estimar)

31 de enero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

5 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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