- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01992679
Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis
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
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Urbana-Champaign, Illinois, Estados Unidos, 61801
- University of Illinois UC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
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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.
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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:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Clinical Disability
Periodo de tiempo: 5 months
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Clinical disability will be indexed by expanded disability status scale.
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5 months
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Quality of Life
Periodo de tiempo: 5 months
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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.
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5 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Walking function
Periodo de tiempo: 5 months
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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.
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5 months
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Balance
Periodo de tiempo: 5 months
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Balance will be quantified with the Berg Balance Scale (BBS); self-report of balance confidence (ABC), and force platform metrics (sway range and velocity).
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5 months
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Cardiorespiratory fitness
Periodo de tiempo: 5 months
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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.
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5 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jacob Sosnoff, PhD, University of Illinois at Urbana-Champaign
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NMSS-IL-011
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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