Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 3:06 PM
Study NCT ID:
NCT05621135
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Sitting Assessment Scale 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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Function Classification System (GMFCS)', 'timeFrame': 'At Baseline', 'description': 'Assessing functional level and motor functions of children with CP.'}, {'measure': 'Manuel ability classification system (MACS)', 'timeFrame': 'At Baseline', 'description': 'This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function.'}, {'measure': 'Gross Motor Function Measure-88', 'timeFrame': 'At Baseline', 'description': 'It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.'}, {'measure': 'Trunk Control Measurement Scale', 'timeFrame': 'At Baseline', 'description': 'This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.'}, {'measure': 'Sitting Assessment Scale', 'timeFrame': 'At Baseline and 2 weeks after the baseline', 'description': 'The Sitting Assessment Scale is a standard observation tool designed for the assessment of sitting in children with CP. The scale consists of five items evaluating head, trunk and foot control and arm and hand functions.The lowest score that can be obtained from the scale is 5 and the highest score is 20. It can be stated that higher scores better functions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Validity'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.', 'detailedDescription': "Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.\n\nEvaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cerebral Palsy will be participate the study between the ages of 2 and 18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Cerebral Palsy voluntary participation,\n* Age between 2-18 years\n\nExclusion Criteria:\n\n* Not voluntary to participate in the research,\n* Botox in the last 6 months,\n* Hip or spine surgeries in the last 6 months'}, 'identificationModule': {'nctId': 'NCT05621135', 'briefTitle': 'Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Gaziantep Islam Science and Technology University'}, 'officialTitle': 'Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy', 'orgStudyIdInfo': {'id': 'GIBTU-FTR-DGK-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '27010', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'Demet GÖZAÇAN KARABULUT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gaziantep Islam Science and Technology University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziantep Islam Science and Technology University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Demet GÖZAÇAN KARABULUT', 'investigatorAffiliation': 'Gaziantep Islam Science and Technology University'}}}}