- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01772186
Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function.
Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase.
Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ruey-Meei Wu, Professor
- Número de teléfono: 2144 886-2-23123456
- Correo electrónico: robinwu@ntu.edu.tw
Copia de seguridad de contactos de estudio
- Nombre: Wen-Chieh Yang, Ph.D. student
- Número de teléfono: 886-2-33668149
- Correo electrónico: d98428003@ntu.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital
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Contacto:
- Ruey-Meei Wu, Professor
- Número de teléfono: 2144 886-2-23123456
- Correo electrónico: robinwu@ntu.edu.tw
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Contacto:
- Wen-Chieh Yang, Ph.D. student
- Número de teléfono: 886-2-33668149
- Correo electrónico: d98428003@ntu.edu.tw
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Investigador principal:
- Ruey-Meei Wu, Professor
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Investigador principal:
- Kwan-Hwa Lin, Professor
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Taipei, Taiwán, 100
- Aún no reclutando
- National Taiwan University Hospital
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Contacto:
- Ruey-Meei Wu, Professor
- Número de teléfono: 2144 886-2-23123456
- Correo electrónico: robinwu@ntu.edu.tw
-
Contacto:
- Wen-Chieh Yang, Ph.D. student
- Número de teléfono: 886-2-33668149
- Correo electrónico: d98428003@ntu.edu.tw
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Investigador principal:
- Ruey-Meei Wu, Professor
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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:
- Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
- Suffering freezing-of-gait in the recent week
- Able to walk unassisted over 30 meters in medication OFF period
Exclusion Criteria:
- Non-idiopathic Parkinsonian
- Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
- Impaired cognitive function
- Abnormal plantar sensory function
- Abnormal coagulation function
Plan de estudios
¿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 |
---|---|
Sin intervención: Without real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
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Experimental: With real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
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A novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes.
This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Reliability of the somatosensory stimulation system
Periodo de tiempo: 2 weeks
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The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
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2 weeks
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Validity of the somatosensory stimulation system
Periodo de tiempo: 2 weeks
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If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
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2 weeks
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Fall prevention
Periodo de tiempo: 10 weeks
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If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
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10 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ruey-Meei Wu, Professor, Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- Investigador principal: Kwan-Hwa Lin, Professor, Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
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
- 201112158DIB
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