Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-06-21 @ 5:28 PM
Study NCT ID:
NCT03191695
Status:
UNKNOWN
Last Update Posted:
2018-08-28
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Participation to Life of Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-25', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life Habits Questionnaire (LIFE-H)', 'timeFrame': 'At baseline', 'description': 'Assessing of the participation level of children'}], 'secondaryOutcomes': [{'measure': 'Gross Motor Function Classification System (GMFCS)', 'timeFrame': 'At baseline', 'description': 'Assessing severity of the disability of children'}, {'measure': 'Pediatric Outcomes Date Collection (PODCI) (Questionnaire)', 'timeFrame': 'At baseline', 'description': 'Assessing health-related quality of life of children by parent proxy questionnaire'}, {'measure': 'Manual Ability Classification System (MACS)', 'timeFrame': 'At baseline', 'description': 'Assessing the manual abilities'}, {'measure': 'Communication Function Classification System (CFCS)', 'timeFrame': 'At baseline', 'description': 'Assessing communication skill'}, {'measure': 'The Child Health Quality (CHQ PF-50)', 'timeFrame': 'At baseline', 'description': 'Assessing health-related quality of life'}, {'measure': 'Pediatric Quality of Life Questionnaire (PedsQL)', 'timeFrame': 'At baseline', 'description': 'Assessing health-related quality of life'}, {'measure': 'The Measure of Processes of Care (MPOC) (Questionnaire)', 'timeFrame': 'At baseline', 'description': 'Assessing health care process of children by parent proxy questionnaire'}, {'measure': 'Impact on Family Scale (IPFAM)', 'timeFrame': 'At baseline', 'description': 'Assessing family impact'}, {'measure': 'Pediatric Evaluation of Disability Inventory', 'timeFrame': 'At baseline', 'description': 'Assessing disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Participation', 'Activity', 'Cerebral Palsy', 'LIFE Habits (life-H)', 'Gross Motor Function', 'Health-related Quality of Life', 'Family'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '22372945', 'type': 'BACKGROUND', 'citation': 'Himuro N, Kozuka N, Mori M. Measurement of family-centred care: translation, adaptation and validation of the Measure of Processes of Care (MPOC-56 and -20) for use in Japan. Child Care Health Dev. 2013 May;39(3):358-65. doi: 10.1111/j.1365-2214.2012.01371.x. Epub 2012 Feb 28.'}, {'pmid': '17057460', 'type': 'BACKGROUND', 'citation': 'Bodkin AW, Robinson C, Perales FP. Reliability and validity of the gross motor function classification system for cerebral palsy. Pediatr Phys Ther. 2003 Winter;15(4):247-52. doi: 10.1097/01.PEP.0000096384.19136.02.'}, {'pmid': '15257969', 'type': 'BACKGROUND', 'citation': 'Berg M, Jahnsen R, Froslie KF, Hussain A. Reliability of the Pediatric Evaluation of Disability Inventory (PEDI). Phys Occup Ther Pediatr. 2004;24(3):61-77. doi: 10.1300/j006v24n03_05.'}, {'pmid': '16199947', 'type': 'BACKGROUND', 'citation': 'Damiano DL, Gilgannon MD, Abel MF. Responsiveness and uniqueness of the pediatric outcomes data collection instrument compared to the gross motor function measure for measuring orthopaedic and neurosurgical outcomes in cerebral palsy. J Pediatr Orthop. 2005 Sep-Oct;25(5):641-5. doi: 10.1097/01.bpo.0000167079.83835.22.'}]}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development. Motor problems in CP are usually accompanied by sensory and perceptual disorders, cognitive disorders, communication and behavioral disorders, epilepsy, and secondary musculoskeletal system problems. The first 20 years of life is characterized by rapid growth and specific changes in physical, social, and psychological development. Social participation and independence of children and youth are related to the changes in this period. Participation can be identified as being involved in life situations and it reflects the social aspect of functionality. The problems which can be come across in life situations are identified as participation limitation. In literature, no adequate study has investigated the functional inadequacy, activity and participation of children with CP; this project has been planned in order to specify the importance in rehabilitation interventions more detailed. This project aims to specify whether the functional levels correspond to the activity and participation limitations of children with CP living in Ankara city center and determine the effects of their functional status on activity, participation and quality of life. This investigation will be pioneer in indicating the activity and participation limitations of children with CP. According to the results, these limitations will be overcome and the quality of life of children with CP will be increased. The CP follow-up database in Ankara will be specified so their physical activity and participation levels will be followed periodically and CP profile will be determined in Ankara.', 'detailedDescription': 'Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development.The first 20 years of life is characterized by rapid growth and specific changes in physical, social, and psychological development. Social participation and independence of children and youth are related to the changes in this period. Participation can be identified as being involved in life situations and it reflects the social aspect of functionality. The problems which can be come across in life situations are identified as participation limitation. In the past, the impairment seen in child was concentrated and child was the passive receptor of treatment. Today, this view is changed and child is the active participant of the treatment of disability. The aim of treatment is identified as increasing the quality of life by supporting the activity and participation according to the priorities of the child and the parent.\n\nIn literature, no adequate study has investigated the functional inadequacy, activity and participation of children with CP; this project has been planned in order to specify the importance in rehabilitation interventions more detailed. This project aims to specify whether the functional levels correspond to the activity and participation limitations of children with CP living in Ankara city center and determine the effects of their functional status on activity, participation and quality of life. This investigation will be pioneer in indicating the activity and participation limitations of children with CP. According to the results, these limitations will be overcome and the quality of life of children with CP will be increased. The CP follow-up database in Ankara will be specified so their physical activity and participation levels will be followed periodically and CP profile will be determined in Ankara. Moreover, the results of this study will be shared with the Ministry of National Education, the Ministry of Family and Social Policies, and the Ministry of Health and this will bring a different viewpoint to the community-based rehabilitation services in Turkey. Furthermore, this study will be expected to motivate countrywide investigations.\n\nIn the project, Gross Motor Function Classification System (GMFCS) for the severity of the disability of people with CP, The Measure of Processes of Care (MPOC) for their care process, the Pediatric Outcomes Date Collection (PODCI) Instrument and Pediatric Quality of Life Questionnaire and The Child Health Quality (CHQ PF-50) for their health-related quality of life, the Manual Ability Classification System (MACS) for the manual abilities and the Communication Function Classification System (CFCS) for the communication skill and the Life Habits Questionnaire (LIFE-H) for the participation level and Impact on Family Scale (IPFAM) for family impact will be used and the outcomes will be analyzed by adequate statistical methods. It is intended to be discussed the findings of the project in national and international platforms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects will be recruited from children who lives in Ankara city and, attend special education centers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* To be diagnosed as cerebral palsy\n\nExclusion Criteria:\n\n* Children whose family didn't accept to participate to study"}, 'identificationModule': {'nctId': 'NCT03191695', 'acronym': 'PLCC', 'briefTitle': 'Participation to Life of Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Investigation of Necessity, Participation to Life of Children With Cerebral Palsy and Their Families', 'orgStudyIdInfo': {'id': '116S359-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment via questionnaire', 'type': 'OTHER', 'description': 'All the children will be assessed via assessment questionnaires.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mintaze Kerem Günel', 'role': 'CONTACT'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mintaze KEREM GÜNEL', 'role': 'CONTACT', 'email': 'mintaze@yahoo.com', 'phone': '+905327164221'}, {'name': 'Ayşe Numanoğlu Akbaş', 'role': 'CONTACT', 'email': 'aysenumanoglu@gmail.com', 'phone': '+905058644036'}], 'overallOfficials': [{'name': 'Mintaze KEREM GÜNEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}, {'name': 'Cumhuriyet University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Mintaze Kerem Gunel', 'investigatorAffiliation': 'Hacettepe University'}}}}