Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-01 @ 8:07 AM
Study NCT ID:
NCT03195335
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Version of LIFE Habits Assessment
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-25', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Participation', 'LIFE Habits (life-H)', 'Validity', 'Reliability'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.'}, {'type': 'BACKGROUND', 'citation': 'Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.'}]}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.'}, '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': 'NCT03195335', 'acronym': 'TVoLHA', 'briefTitle': 'Turkish Version of LIFE Habits Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '116S359'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cerebral palsy', 'description': 'Children who diagnosed as cerebral palsy by a pediatric neurologist', 'interventionNames': ['Other: Assessment via questionnaire']}], 'interventions': [{'name': 'Assessment via questionnaire', 'type': 'OTHER', 'description': 'All the children will be assessed via assessment questionnaires.', 'armGroupLabels': ['Children with cerebral palsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mintaze KEREM GÜNEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cumhuriyet University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Doc. Dr.', 'investigatorFullName': 'Mintaze Kerem Gunel', 'investigatorAffiliation': 'Hacettepe University'}}}}