- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07813052
Effects of Exercise Combined With Cognitive Training on Motor Performance in Children With Developmental Coordination Disorder
Effects of Exercise Combined With Cognitive Training on Balance, Motor Skills and Physical Fitness Among Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Background: Developmental Coordination Disorder(DCD) is a common neuro-developmental disorder in childhood, characterized by deficits in motor coordination. This study aimed to examine the effects of exercise combined with cognitive training versus exercise-only training on balance-postural control, gross motor skills and physical fitness in children with DCD.
Methods: A single-blind randomized controlled trial was conducted. Twenty children aged 7-11 years diagnosed with DCD were randomly allocated into experimental group(n=10) receiving 10-week combined exercise-cognitive training and control group(n=10) receiving exercise-only training. Training was implemented 3 sessions per week, 60 minutes per session for 10 weeks. Outcome assessments were performed at baseline, week-6 and week-10. Motor performance indicators included Y-balance test, eyes-closed single-leg stand, BOT-2 gross-motor sub-scale and national student physical fitness tests.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200438
- Shanghai University of Sport
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged between 7-11 years old.
- Satisfied screening criteria for Developmental Coordination Disorder: MABC-2 total percentile ≤16 or sub-item percentile ≤5; meet age-cut-off score of DCD-Q questionnaire.
- Caregiver reported motor difficulties have presented from early developmental stage.
- Participants are capable of completing all training and assessment procedures.
- Written informed consent provided by legal guardians.
Exclusion Criteria:
- Diagnosed with autism spectrum disorder, ADHD or other neurodevelopmental disorders.
- Severe organic disease that contraindicates physical exercise.
- Receiving concurrent physical therapy or occupational therapy targeting motor coordination during study period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Combined motor-cognitive training group
Children with Developmental Coordination Disorder received combined motor-cognitive training.
Each session integrated physical exercise and cognitive tasks to improve motor performance
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Participants received 10-week training, 3 sessions per week, 60 minutes per session.
Each session contained 30-minute fundamental motor-skill exercise (running, jumping, kicking, throwing, catching), plus 30-minute cognitive training consisting of action observation, motor-imagery guided tasks with picture/video prompts.
Training difficulty was progressively divided into basic phase(1-3w), advanced phase(4-6w), and integration phase(7-10w).
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Comparador activo: Exercise-only training control group
children received general physical-activity training with the same frequency, duration and intensity as the experimental group, without additional cognitive tasks.
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Participants received identical 30-minute fundamental motor-skill physical exercise same as experimental group each session.
Instead of cognitive training, children performed matched quiet non-cognitive rest activity for another 30 minutes, to equalize total trainer-contact time.
The whole intervention lasted 10 weeks, three sessions weekly, 60 minutes each session.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio en las Habilidades Motoras Gruesas Evaluadas por el BOT-2
Periodo de tiempo: Línea de base (preintervención) y postintervención (10 semanas).
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La Prueba Bruininks-Oseretsky de Competencia Motora, Segunda Edición (BOT-2) evalúa las habilidades motoras gruesas, incluyendo el equilibrio, la coordinación bilateral y la velocidad de carrera.
Se reportará la puntuación estándar del Compuesto Motor Total.
La puntuación estándar varía desde un mínimo de 20 hasta un máximo de 80. Puntuaciones más altas indican mejor competencia motora gruesa y coordinación.
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Línea de base (preintervención) y postintervención (10 semanas).
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Change in Dynamic Postural Control Assessed by the Y-Balance
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention (10 weeks).
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Measures maximum controlled reach distance in three directions while maintaining a single-leg stance.
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Baseline (pre-intervention) ,6weeks and post-intervention (10 weeks).
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Change in Static Postural Control Assessed by the Single-Leg Stance Test with Eyes Closed
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Participants stand on one leg with their eyes closed.
The duration (in seconds) they can successfully maintain balance is recorded to evaluate static postural control and proprioceptive integration capacity.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Lower Limb Coordination Assessed by the Side Hop Test
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Participants perform continuous lateral jumps back and forth over a set distance within a limited time.
The total number of successful jumps is recorded to reflect lower limb coordination and rapid posture adjustment ability.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Sprinting Speed Assessed by the 50-Meter Dash
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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The time taken (in seconds) to complete a 50-meter sprint is recorded to evaluate physical speed and acceleration capabilities.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Coordination and Cardiopulmonary Endurance Assessed by the 1-Minute Jump Rope Test
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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The number of valid jumps completed within one minute is recorded to reflect whole-body coordination and cardiopulmonary endurance levels.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Lower Limb Explosive Power Assessed by the Standing Long Jump
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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The maximum valid horizontal jump distance (in centimeters) is recorded to evaluate the explosive power of the lower limbs.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Core Muscle Endurance Assessed by the 1-Minute Sit-Up Test
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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The number of correctly performed sit-ups completed in one minute is recorded to evaluate trunk and core muscle endurance.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Change in Flexibility Assessed by the Sit-and-Reach Test
Periodo de tiempo: Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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The maximum forward reach distance (in centimeters) is recorded to evaluate the flexibility of the lower back and hamstring muscles.
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Baseline (pre-intervention) ,6weeks and post-intervention 10weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Finalización del estudio (Actual)
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SUS-2026-DCD-001
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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