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

Aiyoudong Children and Youth Sports Health Research Institute

Status: Not yet enrolling

Conditions: Neurodevelopmental Disorders

Treatments: Behavioral: Characteristic Exercise Intervention; Behavioral: Traditional Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07323004

2022YFC3600204 (Other Grant/Funding Number)

Basic-2461

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

typical development

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Characteristic Exercise Intervention

General Intervention Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Traditional Rehabilitation