Development Coordination DisorderNCT06802094
Movement Strategies During Balance Tasks in Children With and Without Developmental Coordination Disorder
A study testing Single-session balance intervention in virtual reality in people with Development Coordination Disorder and Typical Developed Children, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Development Coordination Disorder, Typical Developed Children
- What is being tested?
- Single-session balance intervention in virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Aug 2025to 27 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Children who have no formal diagnosis are evaluated by the research team using the diagnostic criteria as outlined in the inclusion criteria, these children will be included as "suspected of having DCD"
- 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.
Who cannot join
- Presence of:
- Intellectual problems
- Visual problems
- Vestibular problems
- Neurological conditions
- Not able to follow instructions due to behavioral problems
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Hasselt Univeristy, Faculty of Rehabilitation Sciences
Diepenbeek, Limburg, 3590
About this study
Official title: Case-Control Research of the Movement Strategies Used During Balance Tasks in Children With and Without Developmental Coordination Disorder
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.
- Being tested
- Single-session balance intervention in virtual reality
- Keywords
- Postural control, Movement strategies, Brain activity, Postural balance [Mesh], Pediatrics [Mesh], Motor Skills Disorders [Mesh]
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session balance intervention in virtual realityOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Single-session balance intervention in virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 30 minutes intervention, one week
Secondary outcomes (2)
Hemodynamic response in cortical brain regions during balance tasks
Measurement of the changes in Oxy- and Deoxyhemoglobin concentrations (μmol/l) (baseline vs task condition), with the use of Functional Near-Infrared Spectroscopy (fNIRS), during the execution of balance tasks. The regions of interest are determinded based on the evidence of brain areas needed for postural control tasks in healthy individuals, and affected brain regions in children with DCD in a variety of tasks (frontal and parietal regions).
The goal is to: (1) determine whether brain activity patterns can be an explanation of the movement strategies used during the single-training session; (2) determine the test-retest reliability of fNIRS during balance tasks in children.
The NIRSport 2 (NIRx Medical Technologies, GE) with continuous wave imaging (760nm;850nm) is used.
Measured: Baseline, one week
Score on a comprehensive postural control measurement, Kids-BESTest-2
Score on the Balance Evaluation Systems Test for Children, second edition. The test consists of 6 domains. A score below 80% is the cut-off which corresponds to a postural control problem. The scores give an idea in which domain of postural control the problems are present.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start18 Aug 2025
- Primary completion27 Oct 2026
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development Coordination DisorderStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-control study (Children with and without Developmental Coordination Disorder) with a follow-up measurement for retention and transfer after one week.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrijn Klingels, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802094
- Sponsor's protocol ID
- B1152024000023
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Research of the Movement Strategies Used During Balance Tasks in Children With and Without Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT06802094
- Acronym / sponsor ID
- B1152024000023
- Keywords
- Postural control, Movement strategies, Brain activity, Postural balance [Mesh], Pediatrics [Mesh], Motor Skills Disorders [Mesh]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 27 Oct 2026 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 30 Jan 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-control study (Children with and without Developmental Coordination Disorder) with a follow-up measurement for retention and transfer after one week.
| Arm | Type | Receives |
|---|---|---|
| Learning of a new balance task in virtual reality | Experimental | Other: Single-session balance intervention in virtual realityAll 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). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- Children who have no formal diagnosis are evaluated by the research team using the diagnostic criteria as outlined in the inclusion criteria, these children will be included as "suspected of having DCD"
- 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
Key exclusion criteria (7 listed)
- Intellectual problems
- Visual problems
- Vestibular problems
- Neurological conditions
- Not able to follow instructions due to behavioral problems
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 |
|---|---|---|
| Single-session balance intervention in virtual realitySingle-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). | Other | Learning of a new balance task in virtual reality |
Primary outcome
Changes in the center of mass velocity and acceleration after a single-training session in VR and after a one-week retention
Time frame: Baseline, after 30 minutes intervention, one week
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.
2 secondary outcomes
Hemodynamic response in cortical brain regions during balance tasks
Time frame: Baseline, one week
Score on a comprehensive postural control measurement, Kids-BESTest-2
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-session balance intervention in virtual reality in people with Development Coordination Disorder and Typical Developed Children, run by Hasselt University at 1 site in Belgium.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 29 Oct 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the center of mass velocity and acceleration after a single-training session in VR and after a one-week retention (time frame: Baseline, after 30 minutes intervention, one week). 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 29 Oct 2026.