NCT06802094

Brief Summary

The main objective of the study is to gain insights in how children learn a balance task and whether there is a difference between children with and without Developmental Coordination Disorder. Furthermore, the investigators are interested in the brain activity of these children while learning this new balance task.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress37%
Aug 2025Aug 2027

First Submitted

Initial submission to the registry

January 27, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

January 27, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Postural controlMovement strategiesBrain activityPostural balance [Mesh]Pediatrics [Mesh]Motor Skills Disorders [Mesh]

Outcome Measures

Primary Outcomes (1)

  • Changes in the center of mass velocity and acceleration after a single-training session in VR and after a one-week retention

    Measurement of the movement strategies used by children with and without Developmental Coordination Disorder (DCD) during a balance task. The movement strategies are measured by looking at the center of mass velocity and acceleration during this balance task. The goal is to: (1) investigate whether there is a difference in the used strategies between baseline and after a single training session of 30 minutes; (2) see whether the changes stay present after a one-week retention; (3) see whether there are differences between children with and without DCD.

    Baseline, after 30 minutes intervention, one week

Secondary Outcomes (2)

  • Hemodynamic response in cortical brain regions during balance tasks

    Baseline, one week

  • Score on a comprehensive postural control measurement, Kids-BESTest-2

    Baseline

Other Outcomes (1)

  • Score on a general motor scale, Movement Assessment Battery for Children, second edition

    Baseline

Study Arms (1)

Learning of a new balance task in virtual reality

EXPERIMENTAL

All children will perform a single training session (30 minutes) in a virtual reality environment, where one game will be played to challenge their balance. After one week, the children will play two games in the virtual reality environment to look at the retention (same game as first session) and transfer (similar game as first session).

Other: Single-session balance intervention in virtual reality

Interventions

Single-session balance intervention (30 minutes) in a virtual reality environment, the Gait Real-time analysis Interactive Lab (GRAIL) or the Computer Assisted Rehabilitation Environment (CAREN) in children with and without Developmental Coordination Disorder (Motek Medical, The Netherlands).

Learning of a new balance task in virtual reality

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • For children with DCD
  • Children with the clinical diagnosis of Developmental Coordination Disorder (DCD) based on criteria of the DSM-5 (APA, 2013), diagnosed by a pediatrician.
  • Balance problems need to be present and objectified with the Balance Evaluation Systems Test for Children, second edition (Kids-BESTest-2). (total score below 80%)
  • For children without DCD
  • Total score at or below the 25th percentile on the Movement Assessment Battery for children, second edition
  • Normal postural control, objectified by the Kids-BESTest-2 (score at or above 80%)
  • Match with children with DCD based on their sex, age and potential comorbidities.

You may not qualify if:

  • Presence of:
  • Intellectual problems
  • Visual problems
  • Vestibular problems
  • Neurological conditions
  • Not able to follow instructions due to behavioral problems
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt Univeristy, Faculty of Rehabilitation Sciences

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Central Study Contacts

Katrijn Klingels

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Case-control study (Children with and without Developmental Coordination Disorder) with a follow-up measurement for retention and transfer after one week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 30, 2025

Study Start

August 18, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations