- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07575178
Obstacle Course Versus Neuromotor Task Training in Children With DCD
Comparison of Obstacle Course Training and Neuromotor Task Training on Motor Planning and Functional Mobility in Children With Developmental Coordination Disorder
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Developmental Coordination Disorder (DCD) is a prevalent neurodevelopmental disorder affecting approximately 5-6% of school-aged children worldwide. Marked by impairments in motor coordination, skill development, and functional performance. The complex etiology of Developmental Coordination Disorder (DCD) is linked to atypical neurodevelopment, genetic predispositions, and associated co-morbidities such as ADHD and ASD, further influenced by perinatal factors like prematurity and low birth weight. DCD is associated with long-term consequences, including difficulties in activities of daily living (ADLs), reduced participation in physical activities, and impaired psychosocial functioning, which collectively increase the risk of obesity and lower self-efficacy. Early, targeted, and task-specific interventions are crucial. Among these, Neuromotor Task Training (NTT) focuses on improving motor planning through structured, cognitive strategies, while Obstacle Course Training (OCT) provides a dynamic setting that promotes functional movement and real-time problem-solving.
This randomized clinical trial will compare the effects of both interventions. The study will be conducted over 10 months at the University of Lahore Teaching Hospital (ULTH) pediatric rehabilitation center and Sehat Medical Complex (SMC) Hanjarwal. The duration of the intervention will be 9 weeks, with 2 sessions per week. There will be two study groups, and convenient sampling techniques will be used. Eligible participants will be children aged 7 to 10 years, both males and females, diagnosed with DCD based on DSM-5 criteria, with a Mini-Mental State Examination (MMSE) score >24 and an IQ above 75 on the Raven Intelligence Scale. Screening for DCD will be done using the Developmental Coordination Disorder Questionnaire (DCDQ) and motor proficiency will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2). Children with a DCDQ score of ≤48 and a BOT-2 score of ≤40 will be included. Children with other neurological, psychiatric, or orthopedic conditions will be excluded. Participants will be randomly assigned to receive either Obstacle Course Training (OCT) or Neuromotor Task Training (NTT) to assess which intervention more effectively improves motor planning and functional mobility. SPSS version 27 will be used for data analysis.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Khadija Liaquat MS-NMPT
- Número de teléfono: 03334956854
- Correo electrónico: khadijaliaquat90@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Imran Amjad Phd, MS
- Número de teléfono: 03324390125
- Correo electrónico: imran.amjad@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Riphah Rehabilitation Center, Riphah International University
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Contacto:
- Imran Amjad Phd
- Número de teléfono: 03324390125
- Correo electrónico: imran.amjad@riphah.edu.pk
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Contacto:
- Khadija Liaquat MS-NMPT
- Número de teléfono: 03334956854
- Correo electrónico: khadijaliaquat90@gmail.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
• Diagnosis of DCD based on DSM4/5 criteria.
- Children aged 7-10.
- Gender male and female.
- Mini-Mental State Examination (MMSE) score >24 .
- Cognitive development appropriate for chronological age.
- Raven Intelligence Test Scale (IQ > 75) .
- Developmental Coordination Questionnaire ≤48 points: likely DCD (≤ 10th percentile).
- BOT-2 score ≤ 40.
Exclusion Criteria:
- History of surgery and lower limb injuries over the past 12 months.
- Use of assistive devices to balance and walk.
- Severe ADHD, Autism Spectrum Disorder (if it significantly interferes with participation), or major psychiatric disorders.
- Taking neuroleptics or any other medications that significantly alter muscle tone, coordination, or attention.
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: Obstacle Course Training (OCT)
Participants will receive structured Obstacle Course Training focused on over-ground walking with obstacle negotiation.
Training targets motor planning, toe clearance, and functional mobility under single- and dual-task conditions.
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Participants will perform Obstacle Course Training on a 12-meter walkway with a midpoint obstacle at low (30% leg length) and high (50% leg length) heights.
Training includes single-task walking (8 trials) and dual-task walking (16 trials) with concurrent visual discrimination tasks using flashcards.
Walking time, toe clearance, and response accuracy will be recorded.
Sessions will be conducted twice weekly for 9 weeks.
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|
Experimental: Neuromotor Task Training (NTT)
Participants will receive neuromotor task training using task-oriented activities focused on motor planning, execution, and evaluation through structured, game-based stations.
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Each session will involve task-oriented activities arranged in multiple stations. Activities will be broken down into planning, execution, and evaluation phases and will include soccer, netball, basketball, tagging games, rope skipping, and other age-appropriate functional games. Children will perform tasks with therapist guidance and feedback to enhance motor planning and performance. Each session will last approximately 45-60 minutes, including warm-up, main activities, and cool-down. The intervention will be delivered over 9 weeks, with 2 sessions per week. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for fine and gross Motor Skills
Periodo de tiempo: 9 weeks
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The BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) scoring converts raw scores into precise motor proficiency metrics for ages 4-21, using sex-specific norms
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9 weeks
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Timed Up and Go Test (TUG)
Periodo de tiempo: 9 weeks
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The Timed Up and Go (TUG) test measures functional mobility and fall risk in seconds.
The test requires a participant to stand up, walk 3 meters, turn, walk back, and sit down.
Results < 10 seconds indicate normal mobility, while times >13.5-14
seconds indicate a higher risk of falls and frailty, requiring further evaluation
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9 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arshmaan Mahmood, MS-PPT, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- 1. Fogel Y, Stuart N, Joyce T, Barnett AL. Relationships between motor skills and executive functions in developmental coordination disorder (DCD): A systematic review. Scandinavian Journal of Occupational Therapy. 2023;30(3):344-56. 2. Castellucci G, Singla R. Developmental Coordination Disorder (Dyspraxia). StatPearls [Internet]: StatPearls Publishing; 2024. 3. Karabak M, Akıncı MA, Yıldırım Demirdöğen E, Bozkurt A. Prevalence and associated factors of developmental coordination disorder in primary school children. European Child & Adolescent Psychiatry. 2024:1-12. 4. Li H, Ke X, Huang D, Xu X, Tian H, Gao J, et al. The prevalence of developmental coordination disorder in children: a systematic review and meta-analysis. Frontiers in Pediatrics. 2024;12:1387406.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Riphah IU-Arshmaan
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.
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