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Not yet recruiting NCT07323004

Motor Development Assessment and Support for Children With Neurodevelopmental Disorders

No phase Interventional Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Characteristic Exercise Intervention, Traditional Rehabilitation.
Who it may be relevant to
Registry conditions: Neurodevelopmental Disorders. Basic parameters: 4 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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
  • 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.

Primary outcome measures

  • Change in Gross Motor Development [Time frame: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)]
  • Change in Motor Coordination [Time frame: Baseline, Week 6, and Week 12]
  • Change in Health-Related Physical Fitness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Health-Related Physical Fitness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Health-Related Physical Fitness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Health-Related Physical Fitness [Time frame: Baseline, Week 6, and Week 12]
  • Change in Gross Motor Development [Time frame: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)]
Secondary outcome measures (12)
  • Change in gait velocity (single task condition) [Time frame: Baseline and Week 12]
  • Change in step size (single-task condition) [Time frame: Baseline and Week 12]
  • Change in Gait Parameters and Dual-Task Cost [Time frame: Baseline and Week 12]
  • Change in Working Memory [Time frame: Baseline and Week 12]
  • Change in SDNN [Time frame: Baseline and Week 12]
  • Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity） [Time frame: Baseline and Week 12]
  • Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6) [Time frame: Baseline and Week 12]
  • Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation) [Time frame: Baseline and Week 12]
  • Change in Gait Parameters and Dual-Task Cost(Changes in gait speed) [Time frame: Baseline and Week 12]
  • Change in Gait Parameters and Dual-Task Cost(Changes in stride length) [Time frame: Baseline and Week 12]
  • Change in Gait Parameters and Dual-Task Cost [Time frame: Baseline and Week 12]
  • Change in Inhibitory Control [Time frame: Baseline and Week 12]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • China Institute of Sport Science — Beijing

Identifiers

NCT: NCT07323004 · Basic-2461 · 2022YFC3600204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗