Motor Development Assessment and Support for Children With Neurodevelopmental Disorders

NCT ID: NCT07323004

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Characteristic Exercise Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aiyoudong Children and Youth Sports Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Institute of Sport Science

Beijing, , China

Countries

China

Central Contacts

yanfeng zhang, Ph. D

Role: CONTACT

zhangyanfeng0310@126.com

+8613641060197

Facility Contacts

yanfeng zhang

Role: primary

zhangyanfeng0316@126.com

+8613641060197

Other Identifiers

2022YFC3600204

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Basic-2461

Identifier Type: -

Identifier Source: org_study_id