- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03764332
Evaluation of the Static Stability of Footwear (EEECS)
Evaluation of the Static Stability of Footwear: A Clinical Trial
Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability.
Objectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Material and methods:
Descripción general del estudio
Descripción detallada
Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen 2 m in front of them at eye level. This was done to standardize the data collection and minimize any variation in postural stability caused by changes in the visual field. Each participant was asked to remain in this position for a period of 30 seconds, while the data was collected. Three repetitions were made for each condition to obtain an average value. The condition on footwear and open / closed eyes was randomized to reduce the learning effect. On the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between shoe changes.
The size of the sample was calculated with the software of the Clinical Epidemiology and Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16 subjects.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Murcia, España, 30008
- Clínica López del Amo
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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:
- Acceptance and signature of informed consent.
- Persons aged between 25-35 years.
- People with a weight between 40 and 95kg.
- People with a height between 1.50 and 1.90m
Exclusion Criteria:
- People with surgical history of lower limbs.
- People with systemic pathology / algia that can alter the physiological static pattern.
- Congenital deformities or acquired in childhood.
- If after a complete exploration in decubitus, sitting, static standing and gait dynamics, any anomaly that could negatively influence the acquisition of data for the study was detected.
- Patients who do not accept or sign the informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Stabilometry
The Podoprint pressure platform was used as a measuring device.
The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz.
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To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Stroke length
Periodo de tiempo: 30 seconds
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Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Stroke surface
Periodo de tiempo: 30 seconds
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Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Relationship between Length / surface
Periodo de tiempo: 30 seconds
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Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Average swing speed
Periodo de tiempo: 30 seconds
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Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Lateral velocity
Periodo de tiempo: 30 seconds
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Average speed of oscillation in its axis of ordinates.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
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30 seconds
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Forward speed
Periodo de tiempo: 30 seconds
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Average oscillation speed on its abscissa axis.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
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30 seconds
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Average displacement in the X axis
Periodo de tiempo: 30 seconds
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Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Average displacement on the Y axis
Periodo de tiempo: 30 seconds
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Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jose Sanchez Saez, Podólogo, Universidade da Coruña
Publicaciones y enlaces útiles
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
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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