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Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis

11 de diciembre de 2014 actualizado por: Jacob Sosnoff, University of Illinois at Urbana-Champaign

Body Weight Supported Treadmill Training in Advanced Multiple Sclerosis

There is growing evidence that exercise-based rehabilitation results in improvements in mobility and participation in persons with multiple sclerosis (MS). However, the vast majority of the scientific evidence in support of this view is based on persons with MS who have minimal mobility impairment. This is partially due to the lack of accessible exercise equipment and facilities available to persons with severe mobility limitations.

One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

24

Fase

  • Fase 2
  • Fase 1

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

    • Illinois
      • Urbana-Champaign, Illinois, Estados Unidos, 61801
        • University of Illinois UC

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 a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • The criteria for inclusion are physician confirmed MS diagnosis, relapse free in the last 30 days, ability to voluntarily contract either quadriceps (e.g. extend their knee), willingness to complete 20 week intervention, and physician approval to engage in manual BWSTT. The diagnosis of MS based on either Poser's or McDonald's criteria and its type based on Lublin and Reingold criteria will be confirmed by the patient's neurologist using a standard form letter.

Exclusion Criteria:

  • The criteria for exclusion are having a relapse in the last 30 days, inability to contract the quadriceps, and unwilling to complete the 20 week intervention.

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 de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
Participants in the control group will undergo the same assessments but receive no exercise stimulus and be asked to maintain current physical levels
Experimental: Exercise group
The exercise program will consist of biweekly training sessions for 20 weeks. Per neurorecovery network guidelines, each training session will include a minimum of 20 minutes of locomotor training and 20 minutes of balance training.
The BWSTT program will consist of biweekly training sessions for 20 weeks. Per neurorecovery network guidelines, each training session will include a minimum of 20 minutes of locomotor training and 20 minutes of balance training. Training will take place on a Therastride which consists of a treadmill with an air pressure powered pulley system connected to a harness system. The locomotor training strategy focuses on proper gait mechanics, including weight bearing, shifting and maintaining body positioning. Manipulating the participant's legs is done in such a way as to provide appropriate sensory-motor cues that facilitate the development and refinement of walking pattern.
Otros nombres:
  • Body-weight supported treadmill triaining

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Disability
Periodo de tiempo: 5 months
Clinical disability will be indexed by expanded disability status scale.
5 months
Quality of Life
Periodo de tiempo: 5 months
Quality of life will be indexed with the Multiple Sclerosis Quality of Life-54 (MSQoL-54) and participation will be indexed with the community participation indicator.
5 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Walking function
Periodo de tiempo: 5 months
Walking speed will be quantified with the Timed 25-Foot Walk and walking endurance will be quantified with the 6-Minute Walk. The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.
5 months
Balance
Periodo de tiempo: 5 months
Balance will be quantified with the Berg Balance Scale (BBS); self-report of balance confidence (ABC), and force platform metrics (sway range and velocity).
5 months
Cardiorespiratory fitness
Periodo de tiempo: 5 months
Cardiorespiratory fitness will be measured as peak oxygen consumption (VO2peak) using an incremental exercise test using an total body recumbent stepper and an open-circuit spirometry system.
5 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jacob Sosnoff, PhD, University of Illinois at Urbana-Champaign

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 octubre de 2013

Finalización primaria (Actual)

1 de septiembre de 2014

Finalización del estudio (Actual)

1 de septiembre de 2014

Fechas de registro del estudio

Enviado por primera vez

12 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2013

Publicado por primera vez (Estimar)

25 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de diciembre de 2014

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

11 de diciembre de 2014

Última verificación

1 de diciembre de 2014

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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