Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT06802094
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Movement Strategies During Balance Tasks in Children With and Without Developmental Coordination Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case-control study (Children with and without Developmental Coordination Disorder) with a follow-up measurement for retention and transfer after one week.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Score on a general motor scale, Movement Assessment Battery for Children, second edition', 'timeFrame': 'Baseline', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Changes in the center of mass velocity and acceleration after a single-training session in VR and after a one-week retention', 'timeFrame': 'Baseline, after 30 minutes intervention, one week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic response in cortical brain regions during balance tasks', 'timeFrame': 'Baseline, one week', 'description': '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).\n\nThe 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.\n\nThe NIRSport 2 (NIRx Medical Technologies, GE) with continuous wave imaging (760nm;850nm) is used.'}, {'measure': 'Score on a comprehensive postural control measurement, Kids-BESTest-2', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postural control', 'Movement strategies', 'Brain activity', 'Postural balance [Mesh]', 'Pediatrics [Mesh]', 'Motor Skills Disorders [Mesh]'], 'conditions': ['Development Coordination Disorder', 'Typical Developed Children']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor children with DCD\n\n* Children with the clinical diagnosis of Developmental Coordination Disorder (DCD) based on criteria of the DSM-5 (APA, 2013), diagnosed by a pediatrician.\n* 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"\n* 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%)\n\nFor children without DCD\n\n* Total score at or below the 25th percentile on the Movement Assessment Battery for children, second edition\n* Normal postural control, objectified by the Kids-BESTest-2 (score at or above 80%)\n* Match with children with DCD based on their sex, age and potential comorbidities.\n\nExclusion Criteria:\n\nPresence of:\n\n* Intellectual problems\n* Visual problems\n* Vestibular problems\n* Neurological conditions\n* Not able to follow instructions due to behavioral problems\n* Refuse to participate'}, 'identificationModule': {'nctId': 'NCT06802094', 'briefTitle': 'Movement Strategies During Balance Tasks in Children With and Without Developmental Coordination Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Case-Control Research of the Movement Strategies Used During Balance Tasks in Children With and Without Developmental Coordination Disorder', 'orgStudyIdInfo': {'id': 'B1152024000023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Learning of a new balance task in virtual reality', 'description': '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).', 'interventionNames': ['Other: Single-session balance intervention in virtual reality']}], 'interventions': [{'name': 'Single-session balance intervention in virtual reality', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Learning of a new balance task in virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3590', 'city': 'Diepenbeek', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maja Van Grinderbeek', 'role': 'CONTACT', 'email': 'maja.vangrinderbeek@uhasselt.be', 'phone': '+32476332092'}, {'name': 'Katrijn Klingels, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maja Van Grinderbeek, Msc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Evi Verbecque, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hasselt Univeristy, Faculty of Rehabilitation Sciences', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}], 'centralContacts': [{'name': 'Maja Van Grinderbeek', 'role': 'CONTACT', 'email': 'maja.vangrinderbeek@uhasselt.be', 'phone': '+32476332092'}, {'name': 'Katrijn Klingels', 'role': 'CONTACT', 'email': 'katrijn.klingels@uhasselt.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Katrijn Klingels', 'investigatorAffiliation': 'Hasselt University'}}}}