- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03300986
Parameter Changes in Functional Electrical Stimulation
This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This group of people have muscle weakness which makes it difficult to lift the foot, which causes trips and falls.
FES reduces foot drop by using a portable device to apply short electrical pulses to the nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase, when the foot is off the floor. Typically this is achieved by using a foot-switch, which detects when the heel leaves the floor. Stimulation begins a short interval of time after the heel leaves the floor, ramps up from zero to set stimulation for the individual, and at another period of time after the heel hits the floor, stimulation ramps down from set amount to zero. There are four time intervals described here which can be varied by the clinician on the device:-
- Delay (the time between heel lift and the start of stimulation)
- Ramp up (the time for stimulation to reach full strength)
- Extension (the time between heel strike and the ramp down)
- Ramp down (the time for stimulation to reach zero from full strength) These intervals are usually set by experienced clinicians using a qualitative assessment of the patient's walking and trial-and-error. A literature review has found no published studies which compare walking with different timing. This knowledge would be useful for clinicians, who could use this information as a starting point in finding the best timing parameters for each patient.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
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:
- Upper motor neurone lesion causing foot drop
- Currently use single-channel Odstock Medical ODFS functional electrical stimulator
- Age 18 or older
- Attending Leeds FES Service follow-up clinics
Exclusion Criteria:
• FES user for less than three months
- Lower limb prosthesis
- Cannot walk 5m with walking aids
- Cannot walk twenty 5m walks within a three-hour period
- Use FES less than once per week
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Functional Electrical Stimulation (FES) users
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Gait analysis will be measured according to routine protocol
Periodo de tiempo: Gait will be assessed over one visit of three hours.
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Gait analysis will measured in accordance with the Plug-In-Gait model guide.
This measures 16 points on the subjects left and right leg.
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Gait will be assessed over one visit of three hours.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MP16/017
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