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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04375059
Effects of Attention Training on Children
Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.
The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.
Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.
The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ru-Lan Hsieh, MD
- Número de teléfono: 2531 886228332211
- Correo electrónico: M001052@ms.skh.org.tw
Copia de seguridad de contactos de estudio
- Nombre: Ru-Lan Ru-Lan, MD
- Número de teléfono: 2531 886228332211
- Correo electrónico: M001052@ms.skh.org.tw
Ubicaciones de estudio
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Taipei, Taiwán, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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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:
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Exclusion Criteria:
- age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Study group
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
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using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
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Sin intervención: Control group
3 months of conventional rehabilitation programs without interactive attention training programs
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
changes of symptoms of attention deficit hyperactivity disorder
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
|
score assessed by Swanson, Nolan and Pelham questionnaire
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
changes of sensory integration
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Sensory Profile
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of visual motor integration
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Beery-Buktenica Visual Motor Integration Test
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of intelligence
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Wechsler Intelligence Scale for Children
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of functional performance
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Pediatric Outcome Data Collection Instrument
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of health-related quality of life
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Pediatric Quality of Life Inventory
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of family impact
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
Child Health Questionnaire, parent form 28
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of walking speed
Periodo de tiempo: time change from baseline to 3 months of treatment, and 3 months after treatment
|
walking speed
|
time change from baseline to 3 months of treatment, and 3 months after treatment
|
changes of chair climbing speed
Periodo de tiempo: time change from baseline to 3 months of treatment, and 3 months after treatment
|
stairs climbing speed
|
time change from baseline to 3 months of treatment, and 3 months after treatment
|
changes of balance
Periodo de tiempo: time change from baseline to 3 months of treatment, and 3 months after treatment
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one leg standing time
|
time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of coordination
Periodo de tiempo: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
Berg Balance Scale
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
changes of balance and coordination
Periodo de tiempo: time change from baseline to 3 months of treatment, and 3 months after treatment
|
timed up and go test
|
time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of physical performance
Periodo de tiempo: time change from baseline to 3 months of treatment, and 3 months after treatment
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5 time sit to stand test
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time change from baseline to 3 months of treatment, and 3 months after treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 2019SKHADR038
Plan de datos de participantes individuales (IPD)
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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.
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