- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04050774
Standing Balance Control Across the Lifespan (BaCoMech)
Balance Control Mechanisms During Perturbed Standing Across the Lifespan
Falls are the leading cause of nonfatal injuries in children and elderly. To understand the causes of falling in these populations, fundamental knowledge of how ageing affects balance control is of utmost importance.
In general, two biomechanical mechanisms allow people to control balance; 1.moving the center of pressure within the base of support using ankle muscle activation; 2.counter-rotating segments around the center of mass. To understand how balance is controlled differently across the lifespan, 4 age groups (each N=20) will be compared to each other; i.e. prepubertal children (6-9y), postpubertal children (15-17y), young adults (18-24y), healthy non-falling older adults (65-80y). .
A force plate platform combined with 3D movement registration will be used to determine the biomechanical balance control strategy across the lifespan during unperturbed and perturbed standing. The innovative but focused scope of this study could provide a breakthrough in our biomechanical understanding of balance control and, in particular, the changes in limitations of balance control in childhood and an ageing (fall-prone) population. The gained fundamental knowledge could lead to unprecedented insights in the causes of falling across the lifespan and in possible targets for intervention.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hasselt, Bélgica, 3500
- Hasselt University
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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:
- prepubertal children (6-9y)
- postpubertal children (15-18y)
- young adults (18-24y)
- healthy non-falling older adults (65-80y) will be included if they 1) did not experience two or more falls during normal daily activities in the preceding year and 2) have no cognitive impairment (tested with Mini-Mental state examination).
Exclusion Criteria:
- inability to speak and understand Dutch;
- inability to maintain independent unsupported stance for 60 seconds;
- current diagnosis of neurological or sensory disorders;
- recurrent dizziness;
- obesity ;
- a history of orthopaedic disorders;
- surgical operation of the lower extremity during last two years;
- use of drugs affecting the CNS or known to affect balance control.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Age group 1
6-9 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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Experimental: Age group 2
15-17 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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Experimental: Age group 3
18 - 24 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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Experimental: Age group 4
65-80 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Balance Control; centre of mass acceleration based on 3D movement registration and ground reaction forces
Periodo de tiempo: day 1
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Centre of mass acceleration (in kg.m2/s2) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.)
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day 1
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Contribution of the ankle strategy to centre of mass acceleration based on 3D movement registration and ground reaction forces
Periodo de tiempo: day 1
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The contribution of the ankle strategy (difference between the centre of pressure and the centre of mass (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.)
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day 1
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Contribution of the counter-rotation mechanism to centre of mass acceleration based on 3D movement registration and ground reaction forces
Periodo de tiempo: day 1
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The contribution of the counter-rotation mechanism (change in angular momentum (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.))
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day 1
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Otros números de identificación del estudio
- Projectlifespanbalance2018-001
Información sobre medicamentos y dispositivos, documentos del estudio
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