Motor Development Assessment and Support for Children With Neurodevelopmental Disorders

NCT07323004 | Not Yet Recruiting

• 2 other identifiers: Basic-24612022YFC3600204
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (15)

• Change in gait velocity (single task condition)

  Baseline and Week 12

• Change in step size (single-task condition)

  Baseline and Week 12

• Change in Gait Parameters and Dual-Task Cost

  Baseline and Week 12

• Change in Working Memory

  Baseline and Week 12

• Change in SDNN

  Baseline and Week 12

Study Arms (3)

typical development

NO INTERVENTION

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

EXPERIMENTAL

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

General Intervention Group

ACTIVE COMPARATOR

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

Interventions

Characteristic Exercise Intervention BEHAVIORAL

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.

Special Intervention Group

Traditional Rehabilitation BEHAVIORAL

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.

General Intervention Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aiyoudong Children and Youth Sports Health Research Institute: lead

Study Sites (1)

China Institute of Sport Science

Beijing, 100061, China

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

yanfeng zhang, Ph. D

CONTACT

+8613641060197; zhangyanfeng0310@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: January 7, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)