NCT07486856

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of an Action Observation and Motor Imagery (AOMI) combined with Fundamental Movement Skills (FMS) intervention for children aged 7 to 11 years with Developmental Coordination Disorder (DCD). The main questions it aims to answer are: Does the AOMI combined with FMS intervention improve basic motor proficiency and posture control in children with DCD? Does this integrated motor-cognitive intervention enhance executive functions, specifically cognitive flexibility, inhibitory control, and spatial working memory? Researchers will compare an experimental group (receiving 30 minutes of AOMI and 30 minutes of FMS per session) to a control group (receiving 30 minutes of FMS and 30 minutes of non-specific activities) to see if the combined approach yields superior outcomes. A total of 20 strictly screened children with DCD will participate. Both groups will attend 60-minute intervention sessions, 3 times a week, for a total of 10 weeks, while maintaining their normal daily school activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

March 21, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Inhibitory Control Assessed by the Stroop Task

    A computerized task evaluating automated response inhibition under conflict. Stimuli are four Chinese color words presented in congruent or incongruent font colors (1:1 ratio). Participants must ignore the meaning and respond only to the font color. The task consists of 68 trials. Performance is assessed via RT and accuracy.

    Baseline (pre-intervention) and post-intervention (10 weeks).

  • Change in Cognitive Flexibility Assessed by the More-Odd Shifting

    A computerized task evaluating rule-switching ability. Stimuli (digits 1-9, excluding 5) require magnitude, parity, or color-cued judgments. Task 1 and 2 are single-rule blocks (58 trials each). Task 3 is a mixed-rule block (59 trials) producing switch and non-switch conditions. Performance is evaluated via Reaction Time (RT) and accuracy.

    Baseline (pre-intervention) and post-intervention (10 weeks).

  • Change in Spatial Working Memory Assessed by the 16-Grid Paradigm

    A computerized task assessing spatial information retention and updating in a 4x4 grid. 4 black squares are presented (1000ms), followed by a blank screen (1000ms), and a target stimulus. Participants judge whether the target is the original pattern rotated by 90°. The task consists of 90 trials divided into 4 blocks.

    Baseline (pre-intervention) and post-intervention (10 weeks).

Secondary Outcomes (10)

  • Change in Gross Motor Skills Assessed by the BOT-2

    Baseline (pre-intervention) and post-intervention (10 weeks).

  • Change in Gross Motor Development Assessed by the TGMD-3

    Baseline (pre-intervention) and post-intervention (10 weeks).

  • Change in Dynamic Postural Control Assessed by the Y-Balance

    Baseline (pre-intervention) and post-intervention (10 weeks).

  • Change in Static Postural Control Assessed by the Single-Leg Stance Test with Eyes Closed

    Baseline (pre-intervention) and post-intervention 10weeks

  • Change in Lower Limb Coordination Assessed by the Side Hop Test

    Baseline (pre-intervention) and post-intervention 10 weeks

  • +5 more secondary outcomes

Study Arms (2)

AOMI Combined with FMS Intervention Group

EXPERIMENTAL

Participants will receive a 10-week motor-cognitive integrated training program, consisting of 60-minute sessions conducted 3 times per week.

Behavioral: Action Observation and Motor Imagery (AOMI) TrainingBehavioral: Fundamental Movement Skills (FMS) Training

Standard FMS Intervention Group

ACTIVE COMPARATOR

Participants will receive a 10-week pure motor intervention, consisting of 60-minute sessions conducted 3 times per week.

Behavioral: Fundamental Movement Skills (FMS) TrainingBehavioral: General Physical Activities

Interventions

Non-specific physical activities lacking specialized cognitive training elements, serving as a time-matched control condition. This component lasts for 30 minutes per session.

Standard FMS Intervention Group

A computerized "observe-imagine-execute" cognitive training framework aimed at enhancing internal motor representations via visual observation and mental imagery. This component lasts for 30 minutes per session.

AOMI Combined with FMS Intervention Group

Physical training progressively focusing on core locomotor and object control skills (e.g., running, jumping, kicking, throwing, catching). This component lasts for 30 minutes per session.

AOMI Combined with FMS Intervention GroupStandard FMS Intervention Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 7 to 11 years, currently enrolled as a primary school student.
  • Meets the diagnostic characteristics of Developmental Coordination Disorder (DCD) according to the DSM-5 criteria, confirmed via standardized screening tools.
  • Total percentile score ≤ 16, or any subtest percentile score ≤ 5 on the Movement Assessment Battery for Children-2 (MABC-2).
  • Score on the Developmental Coordination Disorder Questionnaire (DCD-Q) meets the screening cut-off for the corresponding age group.
  • Parent/guardian reports that motor coordination issues have existed since early development.
  • Possesses basic comprehension skills to understand researchers' instructions and complete motor training and cognitive tasks.
  • Able to participate independently in daily school activities without severe motor functional limitations.
  • Capable of completing the majority of the intervention sessions and the entire testing protocol.

You may not qualify if:

  • Currently receiving systematic specialized sports training or competitive athletic training.
  • Recent surgery or acute injury that significantly impairs motor capacity.
  • Severe neurological diseases or other health conditions that may affect motor performance.
  • Co-morbidity with severe intellectual disability, Autism Spectrum Disorder (ASD), or other developmental disorders that significantly affect the ability to participate in the experiment.
  • Currently receiving rehabilitation treatments or other systematic motor intervention programs (e.g., physical therapy, occupational therapy, or psychomotor training).
  • Inability to complete the behavioral tests or cooperate with the research procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • kun Zhu, Ph.D.

    Shanghai University of Sport

    PRINCIPAL INVESTIGATOR
  • bin Zhang, Ph.D.

    Shanghai University of Sport

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 23, 2026

Study Start

March 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations