Neurodevelopmental Disorders
Conditions
Brief summary
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.
Interventions
BEHAVIORALCharacteristic 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 inclusion of customized play-based movement training and sensory-motor games designed specifically to support neurodevelopmental improvement in young children with motor delays.
BEHAVIORALTraditional 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.
Sponsors
Aiyoudong Children and Youth Sports Health Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gross Motor Development | 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 Motor Coordination | 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 Health-Related Physical Fitness | Baseline, Week 6, and Week 12 | Standing long jump (centimeters) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Memory | Baseline and Week 12 | Description: Performance on a standardized computer-based working memory task. |
| Change in SDNN | Baseline and Week 12 | Standard deviation of normal-to-normal intervals (SDNN) collected from ECG to assess overall heart rate variability. |
| Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity） | Baseline and Week 12 | Diversity of gut microbiota will be analyzed by stool samples (e.g., Alpha diversity index). |
| Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6) | Baseline and Week 12 | Blood samples will be analyzed for levels of the inflammatory marker interleukin-6 (IL-6), usually in picograms per milliliter (pg/mL). |
| Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation) | Baseline and Week 12 | Blood samples will be analyzed for levels of the inflammatory marker tumor necrosis factor-α (TNF-α), usually in picograms per milliliter (pg/mL). |
| Change in gait velocity (single task condition) | Baseline and Week 12 | In single-task conditions, gait speed is measured using a plantar pressure system and reported in meters per second (m/s). |
| Change in Gait Parameters and Dual-Task Cost(Changes in stride length) | Baseline and Week 12 | Under the conditions of a dual-task situation involving cognitive tasks, measure the step length using a plantar pressure system, and report the result in centimeters (cm). |
| Change in Inhibitory Control | Baseline and Week 12 | Performance on a standardized computer-based inhibitory control task. |
| Change in Cognitive Flexibility | Baseline and Week 12 | Performance on a standardized computer-based cognitive flexibility task. |
| Change in RMSSD | Baseline and Week 12 | Root mean square of successive differences (RMSSD) collected from ECG to assess parasympathetic activity. |
| Change in LF/HF Ratio | Baseline and Week 12 | Low-frequency to high-frequency power ratio (LF/HF) derived from ECG spectral analysis to evaluate autonomic balance. |
| Change in Gait Parameters and Dual-Task Cost(Changes in gait speed) | Baseline and Week 12 | Gait speed is measured using a plantar pressure system and reported in meters per second (m/s) in a dual-task condition where cognitive tasks are performed. |
| Change in step size (single-task condition) | Baseline and Week 12 | In single-task conditions, step lengths were measured using a plantar pressure system and reported in centimeters (cm). |
| Change in Gait Parameters and Dual-Task Cost | Baseline and Week 12 | Gait parameters under single-task condition (e.g., gait speed, step length) measured in meters/second and centimeters using a plantar pressure system. |
Countries
China
Contacts
Primary Contactyanfeng zhang, Ph. D
Outcome results
None listed