- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00710645
Lido Workset Study
Assessment of Spasticity in MS Patients Using a Lido Workset
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The information gathered from testing individuals with spasticity due to multiple sclerosis with the Lido Workset has been important in making adjustments to the Lido Workset to show a greater degree of sensitivity in assessing varying degrees of spasticity.
Healthy control subjects will be used to compare the spasticity data of multiple sclerosis subjects with subjects with normal muscle tone to determine the sensitivity of the Lido measurements.
The testing will be performed one time for each patient and will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected subjects from both the MS subjects and control subjects. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks. This additional testing will be done in order to compare the results with the Lido data obtained at similar timepoints from the subjects enrolled in the Cannabis for Spasticity in MS study. Each subject will be given the option to participate in the extended testing or to decline.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
-
Sacramento, California, Estados Unidos, 95817
- University of California, Davis
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Must have a diagnosis of multiple sclerosis and
- Must have some degree of spasticity or
- Must be a healthy control subject
- Ability to give informed consent
Exclusion Criteria:
- Patients with any life-threatening or unstable clinically significant disease
- Patients with other causes of reduced range of motion of the knee or wrist
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Arm I
50 subjects with multiple sclerosis will be tested one time on the Lido Workset.
The test will take approximately 25 minutes.
The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
This testing may be repeated for a group of randomly selected subjects.
Each subject will be given the option to participate in the extended testing or to decline.
The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session.
The total length of time for participation in this study may be up to three weeks.
|
The intervention will consist of spasticity testing on the Lido Workset device.
The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
|
|
Arm II
25 normal subjects will be tested on the Lido workset.
The testing will be performed one time for each patient and will take approximately 25 minutes.
The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
This testing may be repeated for a group of randomly selected control subjects.
Each subject will be given the option to participate in the extended testing or to decline.
The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session.
The total length of time for participation in this study may be up to three weeks.
|
The intervention will consist of spasticity testing on the Lido Workset device.
The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Assess measure of spasticity
Periodo de tiempo: 3 weeks
|
3 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Agius, MD, University of California, Davis
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 (Actual)
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
- 200310977
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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