NCT07868263

Brief Summary

This single-center, single-blind, prospective randomized controlled trial aims to investigate the effects of a video-assisted core stabilization exercise program (Fun-Core) on motor competence, balance, and gait in children with DCD. Children who meet the eligibility criteria will be randomly assigned to either the intervention group or the control group. The intervention group will participate in a video-assisted, story-based, child-friendly Fun-Core exercise program delivered through a web-based platform, whereas the control group will receive the same core stabilization exercises as a home-based program provided in an illustrated brochure format. In both groups, the intervention will last 8 weeks, with exercises performed 3 days per week for approximately 30 minutes per session. The exercise program will consist of two progressive levels, with Level 1 performed during weeks 1-4 and Level 2 during weeks 5-8. Progression to Level 2 will depend on correct and pain-free performance of the exercises, completion of at least 75% of the planned sessions, and absence of exercise-related adverse events. The primary outcome will be motor competence, assessed using the Movement Assessment Battery for Children-Third Edition (MABC-3). The MABC-3 evaluates motor performance across three domains: Manual Dexterity, Aiming and Catching, and Balance. Raw performance scores are converted into age-adjusted standard scores and percentile ranks, with higher scores indicating better motor performance. Secondary outcomes will include balance, functional mobility, participation, health-related quality of life, and static and dynamic pedobarographic parameters. Balance will be evaluated using the Pediatric Balance Scale (PBS), a 14-item scale scored from 0 to 56, with higher scores representing better balance performance. Functional mobility will be evaluated using the Modified Timed Up and Go Test (M-TUG) by recording the time required to stand from a chair, complete the specified mobility task, return, and sit down; shorter completion times indicate better functional mobility. Participation and environmental factors will be evaluated using the Participation and Environment Measure for Children and Youth (PEM-CY), a parent-reported measure assessing participation across home, school, and community settings. Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0), including physical, emotional, social, and school functioning domains, using child self-report and parent proxy-report forms. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. Gait and plantar loading characteristics will additionally be evaluated using static and dynamic pedobarographic assessment with a pressure platform integrated with FreeStep 2.0 software. Static assessment will include plantar pressure distribution, right-to-left load distribution, forefoot-to-rearfoot load distribution, and center of pressure (CoP) parameters. Dynamic assessment during walking at a self-selected natural speed will include plantar pressure distribution, maximum plantar pressure, load transfer patterns, and gait-line parameters. All outcome assessments will be performed by an investigator blinded to group allocation at baseline (Week 0), immediately after the 8-week intervention (Week 8). During the intervention period, participants will be contacted weekly to monitor exercise adherence, general health status, and possible adverse events. Eligible participants will be children aged 5-14 years who meet the DSM-5 diagnostic criteria for DCD and have an MABC-3 Total Standard Score corresponding to the 16th percentile or below. Exclusion criteria will include treatment for motor problems within the previous 6 months; a neurological disorder that primarily explains the motor difficulties; intellectual disability that substantially interferes with participation in assessments or exercises; moderate-to-severe autism spectrum disorder or attention-deficit/hyperactivity disorder, or behavioral problems that interfere with participation; orthopedic deformities preventing exercise; previous lumbar or lower-extremity surgery; moderate-to-severe visual or hearing impairment; and epilepsy or another uncontrolled neurological condition.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2026

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Developmental Coordination Disorder (DCD)Core Stabilization ExerciseVideo-Assisted ExerciseMotor CompetenceBalance and Gait

Outcome Measures

Primary Outcomes (1)

  • Movement Assessment Battery for Children-Third Edition (MABC-3)

    The Movement Assessment Battery for Children-Third Edition (MABC-3) will be used to assess overall motor competence. The MABC-3 consists of eight motor tasks across three domains: Manual Dexterity, Aiming and Catching, and Balance. Raw scores are converted into age-adjusted standard scores using normative data. The MABC-3 Total Motor Score will be used as the primary outcome measure, with higher scores indicating better overall motor performance.

    From baseline to 8 weeks (end of intervention)

Study Arms (2)

Video-Assisted Fun-Core Exercise Group

EXPERIMENTAL
Behavioral: Video-Assisted Fun-Core Exercise Program

Home-Based Core Stabilization Exercise Group

ACTIVE COMPARATOR
Behavioral: Home-Based Core Stabilization Exercise Program

Interventions

An 8-week progressive core stabilization exercise program delivered through a web-based platform using video-assisted, story-based exercise content. Exercises will be performed three times per week for approximately 30 minutes per session.

Video-Assisted Fun-Core Exercise Group

An 8-week progressive home-based core stabilization exercise program provided in an illustrated brochure format. Exercises will be performed three times per week for approximately 30 minutes per session.

Home-Based Core Stabilization Exercise Group

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-14 years. Diagnosis of Developmental Coordination Disorder (DCD) according to the DSM-5 diagnostic criteria.
  • Movement Assessment Battery for Children-Third Edition (MABC-3) Total Standard Score at or below the 16th percentile.

You may not qualify if:

  • Having received any treatment for motor problems within the previous 6 months. Presence of any neurological disorder that could primarily explain the motor difficulties.
  • Presence of intellectual disability at a level that would significantly interfere with the ability to participate in the assessments or exercise program.
  • Presence of moderate-to-severe Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD), or behavioral problems severe enough to interfere with participation in the assessments or exercise program.
  • Presence of an orthopedic deformity that may prevent participation in the exercise program.
  • History of lumbar spine or lower-extremity surgery. Moderate-to-severe visual or hearing impairment. Epilepsy or any uncontrolled neurological condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

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
research assistant

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

October 10, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 14, 2026

Last Updated

October 9, 2026

Record last verified: 2026-10