Construction of a Motor Development Assessment System and an Improvement Mechanism for Children With Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Motor Coordination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
typical development
This group consists of typically developing children aged 4-12 years. No intervention will be applied. The group will be used as a baseline for comparison and analysis of motor development and related health fitness indicators.
Special Intervention Group
This group includes children aged 4-12 years diagnosed with neurodevelopmental disorders. Participants will receive a combined intervention consisting of traditional rehabilitation therapy and a structured, characteristic exercise program designed to improve motor development and core health-related fitness.
干预措施: Characteristic Exercise Intervention (Behavioral)
General Intervention Group
This group includes children aged 4-12 years diagnosed with neurodevelopmental disorders. Participants will receive standard traditional rehabilitation therapy without the additional characteristic exercise intervention.
干预措施: Traditional Rehabilitation (Behavioral)
结局指标
主要结局
Change in Motor Coordination
时间窗: Baseline, Week 6, and Week 12
Evaluated with the Movement Assessment Battery for Children-Second Edition (MABC-2), which measures manual dexterity, aiming and catching, and balance skills.
Change in Gross Motor Development
时间窗: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)
Assessed using the Test of Gross Motor Development-3 (TGMD-3), which evaluates locomotor and object control skills.The scoring ranges from the lowest score of 0 to the highest score of 104 points, and the higher the score, the better the level of motor development.
Change in Health-Related Physical Fitness
时间窗: Baseline, Week 6, and Week 12
Standing long jump (centimeters)
次要结局
- Change in gait velocity (single task condition)(Baseline and Week 12)
- Change in step size (single-task condition)(Baseline and Week 12)
- Change in SDNN(Baseline and Week 12)
- Change in Working Memory(Baseline and Week 12)
- Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity）(Baseline and Week 12)
- Change in Cognitive Flexibility(Baseline and Week 12)
- Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6)(Baseline and Week 12)
- Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation)(Baseline and Week 12)
- Change in Gait Parameters and Dual-Task Cost(Changes in gait speed)(Baseline and Week 12)
- Change in Gait Parameters and Dual-Task Cost(Changes in stride length)(Baseline and Week 12)
- Change in Inhibitory Control(Baseline and Week 12)
- Change in RMSSD(Baseline and Week 12)
- Change in LF/HF Ratio(Baseline and Week 12)
- Change in Gait Parameters and Dual-Task Cost(Baseline and Week 12)