Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-03 @ 3:37 PM
Study NCT ID:
NCT07486856
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor-Cognitive Integrated Intervention for Children With Developmental Coordination Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Inhibitory Control Assessed by the Stroop Task', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': '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.'}, {'measure': 'Change in Cognitive Flexibility Assessed by the More-Odd Shifting', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': '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.'}, {'measure': 'Change in Spatial Working Memory Assessed by the 16-Grid Paradigm', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Gross Motor Skills Assessed by the BOT-2', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) evaluates gross motor skills, including balance, bilateral coordination, and running speed. The Total Motor Composite standard score will be reported. The standard score ranges from a minimum of 20 to a maximum of 80. Higher scores indicate better gross motor proficiency and coordination.'}, {'measure': 'Change in Gross Motor Development Assessed by the TGMD-3', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The Test of Gross Motor Development - Third Edition (TGMD-3) evaluates fundamental locomotor and object control skills. The total score is calculated based on the performance criteria of the skills. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better overall gross motor development.'}, {'measure': 'Change in Dynamic Postural Control Assessed by the Y-Balance', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'Measures maximum controlled reach distance in three directions while maintaining a single-leg stance.'}, {'measure': 'Change in Static Postural Control Assessed by the Single-Leg Stance Test with Eyes Closed', 'timeFrame': 'Baseline (pre-intervention) and post-intervention 10weeks', 'description': 'Participants stand on one leg with their eyes closed. The duration (in seconds) they can successfully maintain balance is recorded to evaluate static postural control and proprioceptive integration capacity.'}, {'measure': 'Change in Lower Limb Coordination Assessed by the Side Hop Test', 'timeFrame': 'Baseline (pre-intervention) and post-intervention 10 weeks', 'description': 'Participants perform continuous lateral jumps back and forth over a set distance within a limited time. The total number of successful jumps is recorded to reflect lower limb coordination and rapid posture adjustment ability.'}, {'measure': 'Change in Sprinting Speed Assessed by the 50-Meter Dash', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The time taken (in seconds) to complete a 50-meter sprint is recorded to evaluate physical speed and acceleration capabilities.'}, {'measure': 'Change in Coordination and Cardiopulmonary Endurance Assessed by the 1-Minute Jump Rope Test', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The number of valid jumps completed within one minute is recorded to reflect whole-body coordination and cardiopulmonary endurance levels.'}, {'measure': 'Change in Lower Limb Explosive Power Assessed by the Standing Long Jump', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The maximum valid horizontal jump distance (in centimeters) is recorded to evaluate the explosive power of the lower limbs.'}, {'measure': 'Change in Core Muscle Endurance Assessed by the 1-Minute Sit-Up Test', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The number of correctly performed sit-ups completed in one minute is recorded to evaluate trunk and core muscle endurance.'}, {'measure': 'Change in Flexibility Assessed by the Sit-and-Reach Test', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (10 weeks).', 'description': 'The maximum forward reach distance (in centimeters) is recorded to evaluate the flexibility of the lower back and hamstring muscles.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Coordination Disorder']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes the AOMI combined with FMS intervention improve basic motor proficiency and posture control in children with DCD?\n\nDoes this integrated motor-cognitive intervention enhance executive functions, specifically cognitive flexibility, inhibitory control, and spatial working memory?\n\nResearchers 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.\n\nA 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.', 'detailedDescription': 'This study employs a single-blind, randomized controlled trial (RCT) with a 2 (Time: pre-test, post-test) × 2 (Group: experimental, control) mixed design framework to investigate the empirical effects of a motor-cognitive integrated intervention for children with Developmental Coordination Disorder (DCD).\n\nFollowing a comprehensive screening process to identify eligible participants, children are randomly assigned to either the experimental group or the active control group.\n\nDuring the 10-week intervention period, participants in both groups attend sessions three times per week. The experimental group receives a structured motor-cognitive integrated training program that uniquely combines Action Observation and Motor Imagery (AOMI) with physical Fundamental Movement Skills (FMS) training. The control group participates in standard FMS training matched for duration and frequency, alongside general physical activities without the specialized cognitive training elements.\n\nTo evaluate the overall efficacy of the integrated approach, comprehensive assessments evaluating motor proficiency, postural control, and executive functions are conducted by blinded assessors before the intervention begins (baseline) and immediately after the 10-week intervention concludes.\n\nAll study procedures adhere strictly to ethical guidelines, and informed consent is obtained from the legal guardians of all participating children prior to the commencement of the research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAged 7 to 11 years, currently enrolled as a primary school student.\n\nMeets the diagnostic characteristics of Developmental Coordination Disorder (DCD) according to the DSM-5 criteria, confirmed via standardized screening tools.\n\nTotal percentile score ≤ 16, or any subtest percentile score ≤ 5 on the Movement Assessment Battery for Children-2 (MABC-2).\n\nScore on the Developmental Coordination Disorder Questionnaire (DCD-Q) meets the screening cut-off for the corresponding age group.\n\nParent/guardian reports that motor coordination issues have existed since early development.\n\nPossesses basic comprehension skills to understand researchers' instructions and complete motor training and cognitive tasks.\n\nAble to participate independently in daily school activities without severe motor functional limitations.\n\nCapable of completing the majority of the intervention sessions and the entire testing protocol.\n\nExclusion Criteria:\n\nCurrently receiving systematic specialized sports training or competitive athletic training.\n\nRecent surgery or acute injury that significantly impairs motor capacity.\n\nSevere neurological diseases or other health conditions that may affect motor performance.\n\nCo-morbidity with severe intellectual disability, Autism Spectrum Disorder (ASD), or other developmental disorders that significantly affect the ability to participate in the experiment.\n\nCurrently receiving rehabilitation treatments or other systematic motor intervention programs (e.g., physical therapy, occupational therapy, or psychomotor training).\n\nInability to complete the behavioral tests or cooperate with the research procedures."}, 'identificationModule': {'nctId': 'NCT07486856', 'briefTitle': 'Motor-Cognitive Integrated Intervention for Children With Developmental Coordination Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Sport'}, 'officialTitle': 'A School-based Motor-cognitive Integrated Training Programme Improves Executive Function and Motor Competence in Children With Developmental Coordination Disorder', 'orgStudyIdInfo': {'id': '102772024RT188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOMI Combined with FMS Intervention Group', 'description': 'Participants will receive a 10-week motor-cognitive integrated training program, consisting of 60-minute sessions conducted 3 times per week.', 'interventionNames': ['Behavioral: Action Observation and Motor Imagery (AOMI) Training', 'Behavioral: Fundamental Movement Skills (FMS) Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard FMS Intervention Group', 'description': 'Participants will receive a 10-week pure motor intervention, consisting of 60-minute sessions conducted 3 times per week.', 'interventionNames': ['Behavioral: Fundamental Movement Skills (FMS) Training', 'Behavioral: General Physical Activities']}], 'interventions': [{'name': 'Action Observation and Motor Imagery (AOMI) Training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['AOMI Combined with FMS Intervention Group']}, {'name': 'Fundamental Movement Skills (FMS) Training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['AOMI Combined with FMS Intervention Group', 'Standard FMS Intervention Group']}, {'name': 'General Physical Activities', 'type': 'BEHAVIORAL', 'description': 'Non-specific physical activities lacking specialized cognitive training elements, serving as a time-matched control condition. This component lasts for 30 minutes per session.', 'armGroupLabels': ['Standard FMS Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai University of Sport', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'kun Zhu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai University of Sport'}, {'name': 'bin Zhang, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai University of Sport'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Sport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhu kun', 'investigatorAffiliation': 'Shanghai University of Sport'}}}}