- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802094
Movement Strategies During Balance Tasks in Children With and Without Developmental Coordination Disorder
Case-Control Research of the Movement Strategies Used During Balance Tasks in Children With and Without Developmental Coordination Disorder
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maja Van Grinderbeek
- Phone Number: +32476332092
- Email: maja.vangrinderbeek@uhasselt.be
Study Contact Backup
- Name: Katrijn Klingels
- Email: katrijn.klingels@uhasselt.be
Study Locations
-
-
Limburg
-
Diepenbeek, Limburg, Belgium, 3590
- Recruiting
- Hasselt Univeristy, Faculty of Rehabilitation Sciences
-
Contact:
- Maja Van Grinderbeek
- Phone Number: +32476332092
- Email: maja.vangrinderbeek@uhasselt.be
-
Principal Investigator:
- Katrijn Klingels, Prof. Dr.
-
Sub-Investigator:
- Maja Van Grinderbeek, Msc
-
Sub-Investigator:
- Evi Verbecque, Prof. Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Presence of:
- Intellectual problems
- Visual problems
- Vestibular problems
- Neurological conditions
- Not able to follow instructions due to behavioral problems
- Refuse to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Learning of a new balance task in virtual reality
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, after 30 minutes intervention, one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic response in cortical brain regions during balance tasks
Time Frame: Baseline, one week
|
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. |
Baseline, one week
|
|
Score on a comprehensive postural control measurement, Kids-BESTest-2
Time Frame: Baseline
|
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.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score on a general motor scale, Movement Assessment Battery for Children, second edition
Time Frame: Baseline
|
The MABC-2 consists of 3 domains (manual dexterity, aiming and catching, balance) with a total of 8 tasks.
The test gives a general idea about the motor develompment of children on different domains.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1152024000023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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