Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-18 @ 2:24 AM
Study NCT ID:
NCT05206461
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Trunk Control and Hand Function and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-29', 'releaseDate': '2023-09-29'}], 'estimatedResultsFirstSubmitDate': '2023-09-29'}}, '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trunk Control Measurement Test', 'timeFrame': 'Baseline', 'description': 'Trunk control'}, {'measure': '9-Hole Peg Test', 'timeFrame': 'Baseline', 'description': 'Hand function'}, {'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'Baseline', 'description': 'Quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Trunk Control', 'Hand Function', 'Quality of Life'], 'conditions': ['Cerebral Palsy', 'Quality of Life', 'Hand']}, 'descriptionModule': {'briefSummary': 'Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy.', 'detailedDescription': 'Trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory. Participants were informed about the procedure of the tests. The evaluation period lasted 30-40 minutes for each child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with hemiparetic and diparetic Cerebral Palsy aged 5-18', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 5-18,\n* Having a diagnosis of hemiparetic or diparetic CP,\n* To be at the level of I-II-III according to the Gross Motor Function Classification System,\n* Not having had orthopedic surgery on the upper extremity in the last 6 months,\n* Not having been injected with Botulinum Toxin-A in the last 6 months,\n* Accepting the study and signing the consent form.\n\nExclusion Criteria:\n\n* Children who could not understand and follow simple verbal commands,\n* Did not meet the inclusion criteria,\n* Incomplete assessments.'}, 'identificationModule': {'nctId': 'NCT05206461', 'briefTitle': 'Relationship Between Trunk Control and Hand Function and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'The Trunk Control Which is Fundamental in Hemiparetic and Diparetic Cerebral Palsied Children: Its Relationship With Hand Function and Quality of Life', 'orgStudyIdInfo': {'id': 'KaratayU1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemiparetic CP', 'description': 'Trunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Hemiparetic CP', 'interventionNames': ['Other: Trunk Control Measurement Scale']}, {'label': 'Diparetic CP', 'description': 'Trunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Diparetic CP', 'interventionNames': ['Other: Trunk Control Measurement Scale']}], 'interventions': [{'name': 'Trunk Control Measurement Scale', 'type': 'OTHER', 'otherNames': ['9-Hole Peg Test', 'Pediatric Quality of Life Inventory'], 'description': 'Trunk Control Measurement Scale, easy and simple to use, was used to evaluate trunk control', 'armGroupLabels': ['Diparetic CP', 'Hemiparetic CP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42030', 'city': 'Konya', 'state': 'Karatay', 'country': 'Turkey (Türkiye)', 'facility': 'KTO Karatay University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Feride Yarar, Asst Prof,PT', 'role': 'STUDY_CHAIR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-29', 'type': 'RELEASE'}, {'date': '2024-03-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'KTO Karatay University'}}}}