Motor Development Assessment and Support for Children With Neurodevelopmental Disorders

Официальное название

Construction of a Motor Development Assessment System and an Improvement Mechanism for Children With Neurodevelopmental Disorders

Обзор

On the one hand, it helps to understand the motor development of preschool children, so as to provide early intervention means for the prevention of motor retardation and promote the healthy development of preschool children, and on the other hand, different motor intervention strategies are formulated according to the developmental characteristics of children with different core symptoms. It is of great academic value to verify the effectiveness of the program through empirical research on exercise intervention and promote the improvement of motor and cognitive development of children with neurodevelopmental disorders.

Вмешательства

• Поведенческое Characteristic Exercise Intervention
  This intervention combines traditional rehabilitation techniques (e.g., occupational therapy and physical therapy focusing on fine and gross motor skills) with a structured, age-appropriate characteristic exercise program. The program includes dynamic balance training, sensory-motor integration activities, rhythmic movement games, and core stability exercises. * Frequency: 3 sessions per week * Duration: 45 minutes per session * Total Intervention Period: 12 weeks * Distinguishing Feature: The
• Поведенческое Traditional Rehabilitation
  Participants will receive conventional rehabilitation therapy, including basic motor skill exercises, postural control training, and therapist-led occupational therapy sessions aimed at improving daily motor function. * Frequency: 3 sessions per week * Duration: 45 minutes per session * Total Intervention Period: 12 weeks * Distinguishing Feature: This group receives only traditional rehabilitation techniques without any additional structured or characteristic physical activity component.

Первичные конечные точки

• Change in Gross Motor Development [Срок оценки: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)]
• Change in Motor Coordination [Срок оценки: Baseline, Week 6, and Week 12]
• Change in Health-Related Physical Fitness [Срок оценки: Baseline, Week 6, and Week 12]
• Change in Health-Related Physical Fitness [Срок оценки: Baseline, Week 6, and Week 12]
• Change in Health-Related Physical Fitness [Срок оценки: Baseline, Week 6, and Week 12]
• Change in Health-Related Physical Fitness [Срок оценки: Baseline, Week 6, and Week 12]
• Change in Gross Motor Development [Срок оценки: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)]

Вторичные конечные точки (12)

• Change in gait velocity (single task condition) [Срок оценки: Baseline and Week 12]
• Change in step size (single-task condition) [Срок оценки: Baseline and Week 12]
• Change in Gait Parameters and Dual-Task Cost [Срок оценки: Baseline and Week 12]
• Change in Working Memory [Срок оценки: Baseline and Week 12]
• Change in SDNN [Срок оценки: Baseline and Week 12]
• Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity） [Срок оценки: Baseline and Week 12]
• Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6) [Срок оценки: Baseline and Week 12]
• Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation) [Срок оценки: Baseline and Week 12]
• Change in Gait Parameters and Dual-Task Cost(Changes in gait speed) [Срок оценки: Baseline and Week 12]
• Change in Gait Parameters and Dual-Task Cost(Changes in stride length) [Срок оценки: Baseline and Week 12]
• Change in Gait Parameters and Dual-Task Cost [Срок оценки: Baseline and Week 12]
• Change in Inhibitory Control [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

• Children aged 4 to 12 years
• Born at full term (gestational age ≥ 37 weeks and < 42 weeks)
• Provided informed consent signed by their legal guardian
• For the ADHD group:
• Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by a qualified physician (e.g., child psychiatrist or psychologist) according to DSM-5 diagnostic criteria
• For the typical development (control) group:
• No symptoms related to ADHD (e.g., inattention, hyperactivity, impulsivity)
• Normal scores on parent- and teacher-rated behavioral questionnaires (e.g., CBCL, SDQ)
• No history of neurological or psychiatric disorders

Критерии исключения

• Diagnosis of other neurodevelopmental disorders, such as:
• Autism Spectrum Disorder (ASD)
• Learning disabilities
• Epilepsy, cerebral palsy, or other neurological conditions
• Developmental quotient (DQ) < 85, as measured by standardized tools (e.g., Gesell scale)
• Significant visual or hearing impairments, or congenital malformations
• History of high-risk birth events, including but not limited to:
• Severe birth asphyxia
• Intrauterine infections
• Presence of genetic or metabolic disorders, or severe dysfunction of vital organs
• For the ADHD group: comorbid psychiatric conditions (e.g., schizophrenia, severe mood disorders)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• China Institute of Sport Science — Пекин

Идентификаторы

NCT: NCT07323004 · Basic-2461 · 2022YFC3600204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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