Neurodevelopmental DisordersCAMD-NDDNCT07323004
Motor Development Assessment and Support for Children With Neurodevelopmental Disorders
A study testing Characteristic Exercise Intervention and Traditional Rehabilitation in people with Neurodevelopmental Disorders, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Characteristic Exercise Intervention and Traditional Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China Institute of Sport Science
Beijing, 100061
yanfeng zhang, +8613641060197, zhangyanfeng0316@126.com
About this study
Official title: Construction of a Motor Development Assessment System and an Improvement Mechanism 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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Characteristic Exercise Intervention, Traditional Rehabilitation
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characteristic Exercise InterventionBehavioural
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 RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness
Standing long jump (centimeters)
Measured: Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness
Continuous two-foot jump (times)
Measured: Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness
10m shuttle run (seconds)
Measured: Baseline, Week 6, and Week 12
Change in Health-Related Physical Fitness
Balance Beam Walk
Measured: 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.
Measured: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)
Secondary outcomes (15)
Change in gait velocity (single task condition)
In single-task conditions, gait speed is measured using a plantar pressure system and reported in meters per second (m/s).
Measured: Baseline and Week 12
Change in step size (single-task condition)
In single-task conditions, step lengths were measured using a plantar pressure system and reported in centimeters (cm).
Measured: Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost
Gait parameters under single-task condition (e.g., gait speed, step length) measured in meters/second and centimeters using a plantar pressure system.
Measured: Baseline and Week 12
Change in Working Memory
Description: Performance on a standardized computer-based working memory task.
Measured: Baseline and Week 12
Change in SDNN
Standard deviation of normal-to-normal intervals (SDNN) collected from ECG to assess overall heart rate variability.
Measured: Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers（Changes in gut microbiota diversity）
Diversity of gut microbiota will be analyzed by stool samples (e.g., Alpha diversity index).
Measured: Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers(Changes in the level of the inflammatory marker IL-6)
Blood samples will be analyzed for levels of the inflammatory marker interleukin-6 (IL-6), usually in picograms per milliliter (pg/mL).
Measured: Baseline and Week 12
Change in Gut Microbiota Composition and Inflammatory Markers(Changes in TNF-α Levels, a Marker of Inflammation)
Blood samples will be analyzed for levels of the inflammatory marker tumor necrosis factor-α (TNF-α), usually in picograms per milliliter (pg/mL).
Measured: Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost(Changes in gait speed)
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.
Measured: Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost(Changes in stride length)
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).
Measured: Baseline and Week 12
Change in Gait Parameters and Dual-Task Cost
Dual-task cost (percent) calculated as the relative difference between single-task and dual-task gait performance.
Measured: Baseline and Week 12
Change in Inhibitory Control
Performance on a standardized computer-based inhibitory control task.
Measured: Baseline and Week 12
Change in Cognitive Flexibility
Performance on a standardized computer-based cognitive flexibility task.
Measured: Baseline and Week 12
Change in RMSSD
Root mean square of successive differences (RMSSD) collected from ECG to assess parasympathetic activity.
Measured: Baseline and Week 12
Change in LF/HF Ratio
Low-frequency to high-frequency power ratio (LF/HF) derived from ECG spectral analysis to evaluate autonomic balance.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323004
- Sponsor's protocol ID
- Basic-2461
- Other IDs
- 2022YFC3600204
- Acronym
- CAMD-NDD
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Motor Development Assessment System and an Improvement Mechanism for Children With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT07323004
- Acronym / sponsor ID
- CAMD-NDD / Basic-2461
- Conditions
- Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research InstituteUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Characteristic Exercise InterventionThis 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. |
| General Intervention Group | Active comparator | Behavioral: Traditional RehabilitationThis group includes children aged 4-12 years diagnosed with neurodevelopmental disorders. Participants will receive standard traditional rehabilitation therapy without the additional characteristic exercise intervention. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Characteristic Exercise InterventionThis 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. | Behavioural | Special Intervention Group |
| Traditional RehabilitationParticipants 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. | Behavioural | General Intervention Group |
Primary outcome
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.
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.
Change in Health-Related Physical Fitness
Time frame: Baseline, Week 6, and Week 12
Standing long jump (centimeters)
Change in Health-Related Physical Fitness
Time frame: Baseline, Week 6, and Week 12
Continuous two-foot jump (times)
Change in Health-Related Physical Fitness
Time frame: Baseline, Week 6, and Week 12
10m shuttle run (seconds)
Change in Health-Related Physical Fitness
Time frame: Baseline, Week 6, and Week 12
Balance Beam Walk
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.
15 secondary outcomes
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
Change in Cognitive Flexibility
Time frame: Baseline and Week 12
Change in RMSSD
Time frame: Baseline and Week 12
Change in LF/HF Ratio
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Characteristic Exercise Intervention and Traditional Rehabilitation in people with Neurodevelopmental Disorders, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yanfeng zhang, Ph. D (+8613641060197, zhangyanfeng0310@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Development (time frame: Baseline, Week 6 (midpoint), and Week 12 (post-intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.