Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-29 @ 10:39 PM
Study NCT ID:
NCT03219112
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2017-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-25'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pediatric Balance Scale compared to baseline', 'timeFrame': 'measured at baseline, after 40 minutes (of training), and after 8 weeks of training', 'description': 'Clinical balance scale with 14 items such as standing unsupported for 30 sec.'}], 'secondaryOutcomes': [{'measure': "Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline", 'timeFrame': 'measured at baseline, after 40 minutes (of training), and after 8 weeks of training', 'description': 'Subscales of a clinical balance scale'}, {'measure': 'Change in Upper body kinematics compared to baseline', 'timeFrame': 'measured at baseline, after 40 minutes (of training), and after 8 weeks of training', 'description': 'Trunk and arm movements measured using 3d movement registration'}, {'measure': 'Change in Posturography compared to baseline', 'timeFrame': 'measured at baseline, after 40 minutes (of training), and after 8 weeks of training', 'description': 'Measurements on a moveable force-platform including the limits of stability during standing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balance', 'rehabilitation', 'exergaming', 'virtual reality'], 'conditions': ['Cerebral Palsy, Spastic']}, 'referencesModule': {'references': [{'pmid': '34365883', 'type': 'DERIVED', 'citation': 'Meyns P, Blanckaert I, Bras C, Jacobs N, Harlaar J, van de Pol L, Plasschaert F, Van Waelvelde H, Buizer AI. Exergaming improves balance in children with spastic cerebral palsy with low balance performance: results from a multicenter controlled trial. Disabil Rehabil. 2022 Oct;44(20):5990-5999. doi: 10.1080/09638288.2021.1954704. Epub 2021 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'In this study the clinical relevance of the use of commercially available virtual reality games in the rehabilitation of balance will be assessed in children with cerebral palsy. It will be investigated how different commercially available platforms (i.e. Xbox One + Kinect and Nintendo Wii + balance board) will affect the compensations of children with cerebral palsy to preserve their balance. The effect of 1 training session will be assessed as well as the effect of a long-term training of 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. children diagnosed with cerebral palsy (spastic type)\n2. age: 8-11 years and 11 months\n3. bilateral CP (diplegia) \\& unilateral CP (hemiplegia)\n4. GMFCS level 1 \\& 2\n5. able to independently stand still for 2 minutes\n6. sufficient cooperation to participate in the measurements and training\n\nExclusion Criteria:\n\n1. No informed consent\n2. surgery of the lower limbs that affects mobility\n3. Botulinum-toxin A treatment within 6 months prior to inclusion in the study\n4. vestibular deficits, benign vertigo, ADHD or instable epilepsia\n\nFor typically developing children:\n\nInclusion criteria;\n\n1. age: 8-11 years and 11 months\n2. no history of neurologic, musculoskeletal or other impairments that could affect mobility'}, 'identificationModule': {'nctId': 'NCT03219112', 'briefTitle': 'Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Training Balance Control Using Virtual Reality Games in Children With Cerebral Palsy and Typically Developing Children', 'orgStudyIdInfo': {'id': 'B670201525057'}, 'secondaryIdInfos': [{'id': '2015/0666', 'type': 'OTHER', 'domain': 'Commission medical ethics University Hospital Ghent'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '15 cp children + 10 typically developing children (anticipated) Will have 8 weeks VR training Will have 1 VR training session', 'interventionNames': ['Other: Balance rehabilitation using X-box One & Kinect']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '15 cp children (anticipated) Will not have 8 weeks of VR training Will not have 1 VR training session'}], 'interventions': [{'name': 'Balance rehabilitation using X-box One & Kinect', 'type': 'OTHER', 'description': 'the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Vakgroep REVAKI (Ghent University - Ghent University hospital)', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}