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NCT Number: NCT07323004

Motor Development Assessment and Support 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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Gross Motor Development

    Time frame: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)

    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.

  2. Change in Motor Coordination

    Time frame: Baseline, Week 6, and Week 12

    Evaluated with the Movement Assessment Battery for Children-Second Edition (MABC-2), which measures manual dexterity, aiming and catching, and balance skills.

  3. Change in Health-Related Physical Fitness

    Time frame: Baseline, Week 6, and Week 12

    Standing long jump (centimeters)

  4. Change in Health-Related Physical Fitness

    Time frame: Baseline, Week 6, and Week 12

    Continuous two-foot jump (times)

  5. Change in Health-Related Physical Fitness

    Time frame: Baseline, Week 6, and Week 12

    10m shuttle run (seconds)

  6. Change in Health-Related Physical Fitness

    Time frame: Baseline, Week 6, and Week 12

    Balance Beam Walk

  7. Change in Gross Motor Development

    Time frame: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)

    Assessed using the Test of Gross Motor Development-3 (TGMD-3), which evaluates locomotor and object control skills.

Secondary outcomes

  1. Change in gait velocity (single task condition)

    Time frame: Baseline and Week 12

    In single-task conditions, gait speed is measured using a plantar pressure system and reported in meters per second (m/s).

  2. Change in step size (single-task condition)

    Time frame: Baseline and Week 12

    In single-task conditions, step lengths were measured using a plantar pressure system and reported in centimeters (cm).

  3. Change in Gait Parameters and Dual-Task Cost

    Time frame: Baseline and Week 12

    Gait parameters under single-task condition (e.g., gait speed, step length) measured in meters/second and centimeters using a plantar pressure system.

  4. Change in Working Memory

    Time frame: Baseline and Week 12

    Description: Performance on a standardized computer-based working memory task.

  5. Change in SDNN

    Time frame: Baseline and Week 12

    Standard deviation of normal-to-normal intervals (SDNN) collected from ECG to assess overall heart rate variability.

  6. Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity）

    Time frame: Baseline and Week 12

    Diversity of gut microbiota will be analyzed by stool samples (e.g., Alpha diversity index).

  7. Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6)

    Time frame: Baseline and Week 12

    Blood samples will be analyzed for levels of the inflammatory marker interleukin-6 (IL-6), usually in picograms per milliliter (pg/mL).

  8. Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation)

    Time frame: Baseline and Week 12

    Blood samples will be analyzed for levels of the inflammatory marker tumor necrosis factor-α (TNF-α), usually in picograms per milliliter (pg/mL).

  9. Change in Gait Parameters and Dual-Task Cost(Changes in gait speed)

    Time frame: Baseline and Week 12

    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.

  10. Change in Gait Parameters and Dual-Task Cost(Changes in stride length)

    Time frame: Baseline and Week 12

    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).

  11. Change in Gait Parameters and Dual-Task Cost

    Time frame: Baseline and Week 12

    Dual-task cost (percent) calculated as the relative difference between single-task and dual-task gait performance.

  12. Change in Inhibitory Control

    Time frame: Baseline and Week 12

    Performance on a standardized computer-based inhibitory control task.

  13. Change in Cognitive Flexibility

    Time frame: Baseline and Week 12

    Performance on a standardized computer-based cognitive flexibility task.

  14. Change in RMSSD

    Time frame: Baseline and Week 12

    Root mean square of successive differences (RMSSD) collected from ECG to assess parasympathetic activity.

  15. Change in LF/HF Ratio

    Time frame: Baseline and Week 12

    Low-frequency to high-frequency power ratio (LF/HF) derived from ECG spectral analysis to evaluate autonomic balance.

Study contacts

Contact information is provided by the study sponsor or research team.

yanfeng zhang, Ph. D

CONTACT

[email protected]

+8613641060197

Sponsors and collaborators

Lead sponsor

Aiyoudong Children and Youth Sports Health Research Institute

Other

Registry information

Official study title

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

Acronym: CAMD-NDD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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