Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
18 de diciembre de 2020 actualizado por: Yannick Bleyenheuft, Université Catholique de Louvain
Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions.
Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Brussels, Bélgica, 1200
- Institute of Neuroscience, Université catholique de Louvain
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
5 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
Exclusion Criteria:
- unstable seizure
- cognitive deficit that prevent understanding of simple games
- botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
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Comparador activo: control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles.
50% of therapeutic time will be performed using the new interactive interface
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Experimental: interface group
high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
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Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities.
50% of therapeutic time will be performed using the new interactive interface
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline Assisting Hand Assessments score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance.
This is a standardized criterion-referenced test.
It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner.
With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline Box and Blocks test score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Test measuring hand function through the number of blocks transported in 1 minute from one part an other of a box placed in front of the child.
Each hand tested separately
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measure of hand function/dexterity, through 7 activities simulating daily life activities.
Each hand is tested separately and time to complete each activity is reported using a stopwatch.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Modified Cooper test at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Measurement of the stereognosis abilities.16
objects are placed in the hand and the child has to recognise the object only by touch.
both hands are tested separately and time to recognise the objects is reported using a stopwatch
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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questionnaire measuring performance of the child in daily life activities focusing on the upper extremities and lower extremities.
Only the self-care domain will be assessed here
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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The Canadian Occupational Performance Measure is a measure designed to capture the patient's self-perception of performance in everyday living, over time.
It consist of a semi-structured interview were the patient elicits daily life activities performed with difficulties (self-care, nutrition, transfer, household management, school, work, transport, leisure, etc).
Five activities are then chosen as the most important to improve and score on a 1 to 10 scale based on the actual patient's performance and satisfaction levels.
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Periodo de tiempo: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Questionnaire measuring social participation
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pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de junio de 2018
Finalización primaria (Actual)
20 de junio de 2020
Finalización del estudio (Actual)
15 de julio de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2019
Publicado por primera vez (Actual)
29 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de diciembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de diciembre de 2020
Última verificación
1 de diciembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B403201316810c
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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