Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 7:14 AM
Study NCT ID:
NCT04634292
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neural correlates during dual tasking in children', 'timeFrame': '2 years', 'description': 'EEG, locomotion parameters, cognitive performances'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Development']}, 'descriptionModule': {'briefSummary': 'Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking', 'detailedDescription': 'Children will walk at their preferred speed on a treadmill. During dual tasking, they will listen to animals cries and will have to count the number of specified animals cries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children and children with cerebral palsy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal walking\n\nFor children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months\n\nExclusion Criteria:\n\n* medical problem'}, 'identificationModule': {'nctId': 'NCT04634292', 'acronym': 'PRALOC', 'briefTitle': 'Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': "Processus Attentionnels impliqués Dans la Locomotion Chez l'Enfant à développement Typique et l'Enfant Atteint de Paralysie cérébrale : Une étude EEG.", 'orgStudyIdInfo': {'id': '38RC20.067'}, 'secondaryIdInfos': [{'id': '2020-A00470-39', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cerebral palsy 7-9 years', 'description': '21 children', 'interventionNames': ['Behavioral: EEG']}, {'label': 'Children with cerebral palsy 10-12 years', 'description': '21 children', 'interventionNames': ['Behavioral: EEG']}, {'label': 'Healthy children 7-9 years', 'description': '21 children', 'interventionNames': ['Behavioral: EEG']}, {'label': 'Healthy children 10-12 years', 'description': '21 children', 'interventionNames': ['Behavioral: EEG']}], 'interventions': [{'name': 'EEG', 'type': 'BEHAVIORAL', 'description': 'EEG + walking task + auditory task', 'armGroupLabels': ['Children with cerebral palsy 10-12 years', 'Children with cerebral palsy 7-9 years', 'Healthy children 10-12 years', 'Healthy children 7-9 years']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}