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Assistive Device Training in Multiple Sclerosis (ADT)

20 de septiembre de 2016 actualizado por: Michelle H. Cameron, MD, PT, MCR, Portland VA Medical Center

Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis

The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.

The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

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

  • Estados Unidos
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • VA Portland Health Care System

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Multiple Sclerosis of any type,
  • self-reported history of at least 1 fall in the previous year,
  • able to walk at least 25 feet with or without an assistive device,
  • clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
  • intermittent or constant unilateral or bilateral assistance required to walk,
  • right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.

Exclusion Criteria:

  • serious psychiatric or medical conditions that would preclude reliable participation in the study,
  • dementia (MMSE <24),
  • deafness,
  • blindness,
  • inability to follow directions in English,
  • significant upper extremity tremor or weakness,
  • more than 1 hour of assistive device training within the previous 3 years,
  • any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Training group
Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program.
Conductual: Assistive Device Training
Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).
Sin intervención: Wait-list control
Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months
Periodo de tiempo: At baseline, 1 week after completion of training, 3 months later
Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12
At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Falls at Completion of Training and the Following Three Months
Periodo de tiempo: First week of training, last week of training, 3 months later
Change in rate of falls between time frames
First week of training, last week of training, 3 months later
Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training
Periodo de tiempo: At baseline, 1 week after completion of training
Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)
At baseline, 1 week after completion of training

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months
Periodo de tiempo: At baseline, 1 week after completion of training, 3 months later
Quebec User Evaluation of Satisfaction with Assistive Technologies
At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months
Periodo de tiempo: At baseline, 1 week after completion of training, 3 months later
Activities-specific Balance Confidence Questionnaire
At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months
Periodo de tiempo: At baseline, 1 week after completion of training, 3 months later
Multiple Sclerosis Impact Scale-29
At baseline, 1 week after completion of training, 3 months later
Change from Baseline in Physical Activity at Completion of Training and the Following Three Months
Periodo de tiempo: At baseline, 1 week after completion of training, 3 months later
International Physical Activity Questionnaire
At baseline, 1 week after completion of training, 3 months later

Colaboradores e Investigadores

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

Patrocinador

Portland VA Medical Center

Colaboradores

Oregon Health and Science University

Investigadores

  • Investigador principal: Michelle H. Cameron, MD, PT MCR, Portland VA Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 julio de 2015

Finalización primaria (Actual)

1 de septiembre de 2016

Finalización del estudio (Actual)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2015

Primero enviado que cumplió con los criterios de control de calidad

2 de abril de 2015

Publicado por primera vez (Estimar)

3 de abril de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de septiembre de 2016

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

20 de septiembre de 2016

Última verificación

1 de abril de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 3559

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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