Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-26 @ 2:01 AM
Study NCT ID:
NCT03241160
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2017-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chewing evaluation', 'timeFrame': '15 days', 'description': 'Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.'}], 'secondaryOutcomes': [{'measure': 'Gross motor function evaluation', 'timeFrame': '15 days', 'description': 'Gross motor function evaluation will be performed according to the Gross Motor Function Classification System.'}, {'measure': 'Trunk control evaluation', 'timeFrame': '15 days', 'description': 'Segmental Assessment of Trunk Control (SATCo) will be performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '30592431', 'type': 'DERIVED', 'citation': 'Serel Arslan S, Demir N, Inal O, Karaduman AA. The severity of chewing disorders is related to gross motor function and trunk control in children with cerebral palsy. Somatosens Mot Res. 2018 Sep-Dec;35(3-4):178-182. doi: 10.1080/08990220.2018.1521788. Epub 2018 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).', 'detailedDescription': 'The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance level will be determined by the chewing performance scale. The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels. Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with a diagnosis of spastic cerebral palsy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of cerebral palsy\n* Referring by a pediatric neurologist\n* Aging between 2 to 12 years\n\nExclusion Criteria:\n\n* Aging under the age of 24 months\n* Using any medicine and/or oral appliances that could affect the chewing performance'}, 'identificationModule': {'nctId': 'NCT03241160', 'briefTitle': 'Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Severity of Chewing Disorders is Related to Gross Motor Function and Trunk Control in Cerebral Palsy', 'orgStudyIdInfo': {'id': 'HACETTEPE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cerebral palsy', 'description': 'Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed.', 'interventionNames': ['Other: Chewing evaluation']}], 'interventions': [{'name': 'Chewing evaluation', 'type': 'OTHER', 'description': 'Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.', 'armGroupLabels': ['Children with cerebral palsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacetttepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'SELEN SEREL ARSLAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SELEN SEREL ARSLAN', 'investigatorAffiliation': 'Hacettepe University'}}}}