Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT02808195
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2016-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance Change assessed by Kinematic analysis', 'timeFrame': 'baseline, 2 months and 6 months', 'description': 'Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.'}], 'secondaryOutcomes': [{'measure': 'score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Melbourne Assessment 2 (MA2)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Pediatric Motor Activity Log-Revised (PMAL-R)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of ABILHAND-kids', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Functional Independence Measures for children (WeeFIM)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Pediatric evaluation of disability inventory (PEDI)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Test of Visual Perceptual Skills-3rd (TVPS-3)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Test of Playfulness (TOP)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Engagement Questionnaire (EQ)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Clint Satisfaction Questionnaire (CSQ)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Parenting Stress Index-Short Form (PSI-SF)', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'Muscle strength', 'timeFrame': 'baseline, 2 months and 6 months', 'description': 'measured by electromyography'}, {'measure': 'score change of Building Tower Test', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Test of String Beads', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}, {'measure': 'score change of Box and Block Test', 'timeFrame': 'baseline, 1 months, 2 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Neurological Rehabilitation', 'Upper Extremity'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '36703170', 'type': 'DERIVED', 'citation': 'Shih TY, Wang TN, Shieh JY, Lin SY, Ruan SJ, Tang HH, Chen HL. Comparative effects of kinect-based versus therapist-based constraint-induced movement therapy on motor control and daily motor function in children with unilateral cerebral palsy: a randomized control trial. J Neuroeng Rehabil. 2023 Jan 27;20(1):13. doi: 10.1186/s12984-023-01135-6.'}, {'pmid': '34765593', 'type': 'DERIVED', 'citation': 'Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.', 'detailedDescription': 'The specific aims of this study project will be:\n\nTo compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria are:\n\n1. 3-16 years old\n2. diagnosed with congenital hemiplegic or CP with one more affected side\n3. considerable nonuse of the affected upper limb.\n\nExclusion criteria are:\n\n1. no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \\& Smith, 1987)\n2. no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation\n3. no injections of botulinum toxin type A or operations on the upper limb within 6 months."}, 'identificationModule': {'nctId': 'NCT02808195', 'briefTitle': 'Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '201601057RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'constraint-induced therapy', 'description': 'training of the more affected arm and restraint the less affected arm', 'interventionNames': ['Other: Constraint-induced therapy']}, {'type': 'EXPERIMENTAL', 'label': 'kinect-based constraint-induced therapy', 'description': 'training of the more affected arm and restraint the less affected arm by kinect-game', 'interventionNames': ['Other: kinect-based constraint-induced therapy']}], 'interventions': [{'name': 'Constraint-induced therapy', 'type': 'OTHER', 'armGroupLabels': ['constraint-induced therapy']}, {'name': 'kinect-based constraint-induced therapy', 'type': 'OTHER', 'armGroupLabels': ['kinect-based constraint-induced therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hao-Ling Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}