- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01968096
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.
Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.
The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taoyuan, Taiwán, 333
- Reclutamiento
- Chang Gung University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Stage 1 subjects: Spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury < 2 years
Stage 2 subjects: Incomplete spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of incomplete spinal cord injury
- ASIA classification:B, C, or D
Stage 3 subjects: Spinal cord injury subjects with high muscle tone
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury.
- ASIA classification: A, B, C, or D
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: SCI subjects
Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.
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Sin intervención: Incomplete SCI subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
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Sin intervención: Health subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
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Experimental: SCI subjects with high muscle tone (High frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .
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A rehabilitation program of machine driven passive stretch.
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Experimental: SCI subjects with high muscle tone(low frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
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A rehabilitation program of machine driven passive stretch.
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Sin intervención: SCI subjects with high muscle tone
Stage 3 subjects:Control subjects
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical muscle tone tests & Peripheral nerve Stimulation machine
Periodo de tiempo: Participants will be followed for the duration of invention, an expected average of 24 weeks.
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Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated. |
Participants will be followed for the duration of invention, an expected average of 24 weeks.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102-1780C
- NSC102-2314-B-182-021-MY2
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