Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01903603
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Movement and Participation in Patients With 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of kinematic analysis in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Kinematic analysis for upper limb and gait analysis'}, {'measure': 'Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months', 'timeFrame': '6 months and 12 months', 'description': 'Healthy children and CP: Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2), Wolf Motor Function Test (WMFT), Block and Box test (BBT), Time up and go, Berg Balance Scale (BBS), Functional Independence Measure for Children (WeeFIM), Children Assessment of Participation and Enjoyment (CAPE), and School Function Assessment (SFA).'}, {'measure': 'Change from baseline of movement and participation for CP in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Measures for CP also include Gross motor function measure (GMFM), Quality of upper extremity test (QUEST), Pediatric Motor Activity Log (PMAL), Caregiver Functional Use Survey (CFUS), etc.'}, {'measure': 'Change from baseline of severity for CP patients in 6 months and 12 months', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'CP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cerebral palsy', 'multi-modal brain techniques', 'MRI', 'Kinematic', 'motor control'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) patients', 'detailedDescription': 'Cerebral palsy (CP) may lead to various motor deficits, which further influence the activities and participation. It would be ideal to characterize neural network and motor control model in patients with CP that underlies their clinical behavior by identifying altered neural network and motor control associated with behavioral improvement. The aim of this study is to investigate the brain image and motor control in patients with CP evaluated by multimodal imaging studies utilizing multi-modal techniques and kinematic analysis.\n\nThis study includes a prospective longitudinal study of patients with CP over one-year. This study will be executed in 3 phases within 3 years: 1st phase (1st years): to establish the multimodal brain images and motor control, and clinical outcomes protocol with a prospective one-year follow-up study in healthy subjects; 2nd phase (2nd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in older patients with CP; and 3rd phase (3rd years): to establish the brain images and motor control, and clinical outcomes with a prospective one-year follow-up study in younger patients with CP. In a prospective longitudinal study, each participant received 3-times measurements: at the beginning, 6 months later, and one year after the first data collection point'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CP and healthy children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Age: 4-20 y/o (2) Good cognition and cooperation (3) Healthy participants\n\nExclusion Criteria:\n\n* (1) Motor problems (2) Neurological, orthopedic, or progressive disorders (3) Active medical diseases, such as infection'}, 'identificationModule': {'nctId': 'NCT01903603', 'briefTitle': 'A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Longitudinal Study of Movement and Participation in Patients With Cerebral Palsy: a Combined Brain Imaging and Kinematic Analysis', 'orgStudyIdInfo': {'id': '100-4545A3'}, 'secondaryIdInfos': [{'id': 'NSC101-2314-B-182-004-MY3', 'type': 'OTHER', 'domain': 'National Science Council'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Children', 'description': 'Inclusion criteria for healthy children were as follows: ages of 4-20 y/o ; good cognition and cooperation; and healthy children.'}, {'label': 'CP subjects', 'description': 'Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 4-20 years old.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Chia-Ling Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}