Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04813393
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2021-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
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': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-03-21', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q)', 'timeFrame': 'At baseline', 'description': 'The CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. İt consist of 22 items. The highest score 110, the lowest score 22.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Life Habits for Children questionnaire (LIFE-H)', 'timeFrame': 'At baseline', 'description': 'The questionnaire was designed and validated to assess the social participation of children with disabilities. It consists of 11 category: nutrition, physical fitness, personal care, mobility, interpersonal communication, social roles, education, recreational activities, responsibilities, housing, and social life. Each Life-H item is ranked on a 0 to 9 scale for accomplishment, where a score of 0 represents "not accomplished" and a score of 9 equals "no difficulty and no assistance."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['home program', 'cerebral palsy', 'questionnaire development', 'parent'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in the current study were parents of chlidren with 2 to 18 years and recruited at Hecettepe Univercity Physical Therapy and Rehabilitation Faculty Cerebral Palsy and Pediatric Rehabilitation Unit.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. having a child with CP 2 to 18 years,\n2. being a primary caregiver,\n3. understanding of Turkish without an interpreter, and Turkish literacy,\n\nExclusion Criteria:\n\n1. having any chronic illness or disability to prevent the home program,\n2. haven't applied home program before."}, 'identificationModule': {'nctId': 'NCT04813393', 'acronym': 'CoPoCPHP', 'briefTitle': 'Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Psychometric Properties of Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire', 'orgStudyIdInfo': {'id': 'GO: 20/357'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire Group', 'description': 'The CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. Parents applied this instrument in the study.', 'interventionNames': ['Other: Questionnaire Development']}], 'interventions': [{'name': 'Questionnaire Development', 'type': 'OTHER', 'description': 'To evaluate psychometric the properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.', 'armGroupLabels': ['Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mutlu Hayran, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe Univercity'}, {'name': 'Meltem Şengelen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe Univercity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Doc.Dr.', 'investigatorFullName': 'Mintaze Kerem Gunel', 'investigatorAffiliation': 'Hacettepe University'}}}}