Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-31 @ 12:42 AM
Study NCT ID:
NCT05757895
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Trunk Control in Spatic 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trunk Affect Level', 'timeFrame': 'First Day', 'description': 'Static Sitting Balance, Dynamic Sitting Balance and Coordination will be evaluated with the Body Impact Scale (TIS). The scale varies between 0-23 points in total, and high scores indicate that the body control is better.'}], 'secondaryOutcomes': [{'measure': 'Activity Level', 'timeFrame': 'First Day', 'description': "Not to measure the feasibility of the quality of the movement, the international functionality, disability and health as defined in the classification of the 'activity level' and determine tilt, rolling, sitting, crawling, kneeling, standing, walking, jumping, running, containing parameters such as the functional activity of focusing on gross motor function Criteria - GMFM-88 will be assessed."}, {'measure': 'Level of Participation', 'timeFrame': 'First Day', 'description': 'The functional health status of children and adolescents with CP between the ages of 2-18 will be evaluated by the Pediatric Data Collection Tool (PODCI), which is developed to determine the level of physical function and participation, but also does not ignore the quality of life, answered by parents.'}, {'measure': 'The level of Quality of Life', 'timeFrame': 'First Day', 'description': 'SP-specific developed in order to assess the quality of life, daily activities, school activities, movement and balance, pain and suffering, fatigue, eating, activities, speech and communication, including 7 Sub Module titles for children of cerebral palsy quality of Life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy, trunk control'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '16108461', 'type': 'BACKGROUND', 'citation': 'Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.'}, {'pmid': '20101192', 'type': 'BACKGROUND', 'citation': 'Bourelle S, Berge B, Gautheron V, Cottalorda J. Computerized static posturographic assessment after treatment of equinus deformity in children with cerebral palsy. J Pediatr Orthop B. 2010 May;19(3):211-20. doi: 10.1097/BPB.0b013e32832e957a.'}, {'pmid': '19549193', 'type': 'BACKGROUND', 'citation': 'Davis E, Shelly A, Waters E, Davern M. Measuring the quality of life of children with cerebral palsy: comparing the conceptual differences and psychometric properties of three instruments. Dev Med Child Neurol. 2010 Feb;52(2):174-80. doi: 10.1111/j.1469-8749.2009.03382.x. Epub 2009 Jun 22.'}, {'pmid': '23139425', 'type': 'BACKGROUND', 'citation': 'Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.'}, {'pmid': '9183258', 'type': 'BACKGROUND', 'citation': 'Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.'}, {'pmid': '23643761', 'type': 'BACKGROUND', 'citation': 'Saether R, Helbostad JL, Adde L, Jorgensen L, Vik T. Reliability and validity of the Trunk Impairment Scale in children and adolescents with cerebral palsy. Res Dev Disabil. 2013 Jul;34(7):2075-84. doi: 10.1016/j.ridd.2013.03.029. Epub 2013 May 1.'}]}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy is a disease characterized by movement, posture and tone disorders that occur in the immature brain structure that has not yet completed its development anatomically and physically, but can undergo permanent changes. Although the prevalence is 2-3/1000 births, this rate is 4.4/1000 births in our country. As the level of development of the country increases, this rate decreases. Cerebral Palsy is clinically classified according to different criteria and types. While the terms hemiplegia, diplegia, tetraplegia are used according to limb involvement, terms such as spastic, ataxic, dyskinetic, hypotonic are used in classification according to dominant tone disorders.\n\nPostural control, which plays a key role in the realization of all our fine and gross motor skills and is necessary for the realization of our daily life activities, is insufficient in children with cerebral palsy, a neurological disorder. Insufficient postural control negatively affects mobility, limb movements, static and dynamic trunk control.\n\nWhen the literature is scanned and trunk postural control more of the physical/motor, we investigated the effect of parameters, which are fundamental for the realization of motor body control functions/is not emphasized enough in postural control, within the framework of the ICF activity and participation and the effects on their quality of life has not been sufficiently studied to be a gap in this area, physical/motor control parameters has a significant influence on the body, which is quite activity, participation and quality of life was significantly etkileyecebi it was assumed that their level. In our study, the 6-12 age group was selected because children with Cerebral Palsy at the primary school level have started to become independent from their parents in their daily life activities and have recently adapted to social activities.\n\nIn this study, it is aimed to investigate the effect of trunk disorder level on activity, participation and quality of life levels of children with Cerebral Palsy at primary school level.', 'detailedDescription': "Cerebral Palsy is a disease characterized by movement, posture and tone disorders that occur in the immature brain structure that has not yet completed its development anatomically and physically, but can undergo permanent changes.Cerebral palsy, neuromuscular diseases and permanent disability among the most widely known throughout the world as the cause of childhood morbidity and mortality rates in takes place at high rates.Many prenatal, perinatal and postnatal problems play a role in the development of Cerebral Palsy. Between Prenatal intrauterine bleeding problems, toxins and infections; perinatal problems between a difficult birth, anoxia; postnatal problems are considered to be among the most frequent causes of premature and low birth weight.\n\nPostural control, which plays a key role in the realization of all our fine and gross motor skills and is necessary for the realization of our daily life activities, is insufficient in children with cerebral palsy, which is a neurological disorder. Insufficient postural control negatively affects mobility, limb movements, static and dynamic trunk control.In recent years, the terms well-being and quality of life have been considered important for the evaluation of health. Well-being is expressed as the well-being of an individual's functional and health condition and an increase in quality of life.SP impaired postural control in children with upper extremity impairment in function, learning difficulties, sensory impairment, dental problems, language-speech disorders, mental retardation, behavior disorders, is illustrated by studies that has a negative impact on quality of life.\n\nWhen the literature is scanned and trunk postural control more of the physical/motor, we investigated the effect of parameters, which are fundamental for the realization of motor body control functions/is not emphasized enough in postural control, within the framework of the ICF activity and participation and the effects on their quality of life has not been sufficiently studied to be a gap in this area, physical/motor control parameters has a significant influence on the body, which is quite activity, participation and quality of life was significantly etkileyecebi it was assumed that their level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '16 patients with Hemiparetic CP and 16 Diparetic CP will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Spastic Cerebral Palsy,\n* located in the December 7-12 age range,\n* Without Severe Mental Retardation,\n* GMFCS level 1-2 and 3 are\n* Given consent to participate in the study by the parent\n\nExclusion Criteria:\n\n* Not given consent to participate in the study by the parent,\n* Having a type of SP, other than Spastic Cerebral Palsy,\n* Severe Mental Retardation and inability to communicate\n* not being in the December 7-12 age range -With GMFCS level 4 and 5'}, 'identificationModule': {'nctId': 'NCT05757895', 'briefTitle': 'Investigation of Trunk Control in Spatic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Investıgatıon of the Effect of Trunk dısorder Level on partıcıpatıon, actıvıty and qualıty of lıfe Level of chıldren wıth Cerebral Palsy at prımary School Level', 'orgStudyIdInfo': {'id': 'Cerebral Palsy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemiparetic SP', 'description': 'The Level of Gross Motor Function Classification System (GMFCS), Trunk Affect Level ( Trunk Impairment Scale- TIS), Activity Level ( Gross Motor Function Criterion- GMFM-88), Participation Level ( Pediatric Data Collection Tool- PODCI) and Quality of Life Level (Cerebral Palsy Questionnaire for Children Cerebral Palsy Module- PedsQL) will be evaluated.'}, {'label': 'Diparetic SP', 'description': 'The Level of Gross Motor Function Classification System (GMFCS), Trunk Affect Level ( Trunk Impairment Scale- TIS), Activity Level ( Gross Motor Function Criterion- GMFM-88), Participation Level ( Pediatric Data Collection Tool- PODCI) and Quality of Life Level (Cerebral Palsy Questionnaire for Children Cerebral Palsy Module- PedsQL) will be evaluated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Karabük University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'overallOfficials': [{'name': 'Funda ŞEKERCİOĞLU Physiotherapist', 'role': 'STUDY_CHAIR', 'affiliation': 'Karabuk University'}, {'name': 'Musa GÜNEŞ MsC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karabuk University'}, {'name': 'Metehan YANA PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karabuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'METEHAN YANA', 'investigatorAffiliation': 'Karabuk University'}}}}