Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-07 @ 2:15 PM
Study NCT ID:
NCT02984735
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2016-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chewing Performance Level and Gross Motor Function in Children With 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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2016-12-03', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chewing performance level', 'timeFrame': '10 minutes', 'description': 'Chewing evaluation'}], 'secondaryOutcomes': [{'measure': 'Gross motor function level', 'timeFrame': '10 minutes', 'description': 'Motor function evaluation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chewing', 'cerebral palsy', 'chewing disorders', 'gross motor function'], 'conditions': ['Cerebral Palsy', 'Chewing Problem', 'Gross Motor Development Delay']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).', 'detailedDescription': 'The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above the age of 24 months\n* Having complaints about chewing function.\n\nExclusion Criteria:\n\n* Under the age of 24 months\n* Requiring tube feeding or taking any oral nutritional supplements\n* Using any medicine and/or oral appliances'}, 'identificationModule': {'nctId': 'NCT02984735', 'briefTitle': 'Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Association Between Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'HACETTEPEUNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evaluation of children with spastic CP', 'description': 'Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.', 'interventionNames': ['Other: Evaluation']}], 'interventions': [{'name': 'Evaluation', 'type': 'OTHER', 'description': "Descriptive characteristics including age, height and weight were recorded. Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS). Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew. The physical therapist rated the chewing performance according to the KCPS. All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS). In addition to GMFCS, number of affected limbs of the children was also noted.", 'armGroupLabels': ['Evaluation of children with spastic CP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacetttepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'SELEN SEREL ARSLAN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Selen Serel Arslan', 'investigatorFullName': 'SELEN SEREL ARSLAN', 'investigatorAffiliation': 'Hacettepe University'}}}}