Motor Development Assessment and Support for Children With Neurodevelopmental Disorders (CAMD-NDD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopmental Disorders
• Intervention / Treatment: Behavioral: Characteristic Exercise Intervention; Behavioral: Traditional Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yanfeng zhang, Ph. D; Phone Number: +8613641060197; Email: zhangyanfeng0310@126.com

Study Locations

• China
  • Beijing, China, 100061
    • China Institute of Sport Science
    • Contact: yanfeng zhang; Phone Number: +8613641060197; Email: zhangyanfeng0316@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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 inclusion of customized play-based movement training and sensory-motor games designed specifically to support neurodevelopmental improvement in young children with motor delays.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gross Motor Development	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.	Baseline, Week 6 (midpoint), and Week 12 (post-intervention)
Change in Motor Coordination	Evaluated with the Movement Assessment Battery for Children-Second Edition (MABC-2), which measures manual dexterity, aiming and catching, and balance skills.	Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness	Standing long jump (centimeters)	Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness	Continuous two-foot jump (times)	Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness	10m shuttle run (seconds)	Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness	Balance Beam Walk	Baseline, Week 6, and Week 12
Change in Gross Motor Development	Assessed using the Test of Gross Motor Development-3 (TGMD-3), which evaluates locomotor and object control skills.	Baseline, Week 6 (midpoint), and Week 12 (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait velocity (single task condition)	In single-task conditions, gait speed is measured using a plantar pressure system and reported in meters per second (m/s).	Baseline and Week 12
Change in step size (single-task condition)	In single-task conditions, step lengths were measured using a plantar pressure system and reported in centimeters (cm).	Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost	Gait parameters under single-task condition (e.g., gait speed, step length) measured in meters/second and centimeters using a plantar pressure system.	Baseline and Week 12
Change in Working Memory	Description: Performance on a standardized computer-based working memory task.	Baseline and Week 12
Change in SDNN	Standard deviation of normal-to-normal intervals (SDNN) collected from ECG to assess overall heart rate variability.	Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity）	Diversity of gut microbiota will be analyzed by stool samples (e.g., Alpha diversity index).	Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6)	Blood samples will be analyzed for levels of the inflammatory marker interleukin-6 (IL-6), usually in picograms per milliliter (pg/mL).	Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation)	Blood samples will be analyzed for levels of the inflammatory marker tumor necrosis factor-α (TNF-α), usually in picograms per milliliter (pg/mL).	Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost(Changes in gait speed)	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.	Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost(Changes in stride length)	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).	Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost	Dual-task cost (percent) calculated as the relative difference between single-task and dual-task gait performance.	Baseline and Week 12
Change in Inhibitory Control	Performance on a standardized computer-based inhibitory control task.	Baseline and Week 12
Change in Cognitive Flexibility	Performance on a standardized computer-based cognitive flexibility task.	Baseline and Week 12
Change in RMSSD	Root mean square of successive differences (RMSSD) collected from ECG to assess parasympathetic activity.	Baseline and Week 12
Change in LF/HF Ratio	Low-frequency to high-frequency power ratio (LF/HF) derived from ECG spectral analysis to evaluate autonomic balance.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Aiyoudong Children and Youth Sports Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: Basic-2461; 2022YFC3600204 (Other Grant/Funding Number: ministry of science and technology of the People's Republic of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No