Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT02930603
Status:
UNKNOWN
Last Update Posted:
2020-06-24
First Post:
2016-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of general developmental for Healthy child and patients with Developmental Disabilities in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Comprehensive Developmental Inventory for Infants and Toddlers'}, {'measure': 'Change from baseline of body function & structures in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Bruininks- Oseretsky Test of Motor Proficiency II'}, {'measure': 'Change from baseline of upper extremity function & structures in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Quality of upper extremity skills test'}, {'measure': 'Change from baseline of lower extremity function & structures in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Pediatric Balance Scale'}, {'measure': 'Change from baseline of Sensory and Perceptual function in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Sensory Profile'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of activities in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Functional Independence Measure for Children'}, {'measure': 'Change from baseline of Participation in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Children Assessment of Participation and Enjoyment, Preferences for Activity of Children'}, {'measure': 'Change from baseline of Quality of Life in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'TNO-AZL Child Quality of Life Questionnaire'}, {'measure': 'Change from baseline of Personal & Environment factor in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Parenting Stress Index,'}, {'measure': 'Change from baseline of Rehabilitation & community service factor in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Measure of Processes of Care'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Developmental Disabilities', 'Body function and body structure', 'Participation', 'Life activities', 'Quality of Life'], 'conditions': ['Child Development Disorders']}, 'descriptionModule': {'briefSummary': 'A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities', 'detailedDescription': 'Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '7 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Control and experimental groups', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with Developmental Disabilities\n2. Age 0-25 y/o\n3. Agree to sign informed consent\n\nExclusion Criteria:\n\n1. Active medical condition (e.g. infection)\n2. Concurrent progressive or degenerative disease (e.g. neurogenerative disease)\n3. Concurrent illness or disease not typically associated with DD (e.g. pneumonia)'}, 'identificationModule': {'nctId': 'NCT02930603', 'briefTitle': 'A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities', 'orgStudyIdInfo': {'id': '102-5441B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Control: Healthy child'}, {'label': 'Experimental', 'description': 'Patients with Developmental Disabilities'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia-Ling Chen, MD, PhD', 'role': 'CONTACT', 'email': 'clingchen@gmail.com', 'phone': '+886-3-3281200', 'phoneExt': '8147'}, {'name': 'Chia-Ling Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Chia-Ling Chen, MD, PhD', 'role': 'CONTACT', 'email': 'clingchen@gmail.com', 'phone': '+886-3-3281200', 'phoneExt': '8148'}], 'overallOfficials': [{'name': 'Chia-Ling Chen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}