Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-20 @ 3:31 PM
Study NCT ID:
NCT02808156
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Unilateral Versus Bilateral Intensive Training in 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'}]}}, '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': 'RECRUITING', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from Melbourne Assessment 2 (MA-2)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from Pediatric Motor Activity Log-Revised (PMAL-R)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from ABILHAND-Kids', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from Test of Playfulness (ToP)', 'timeFrame': 'week 1, week 4, week 5, week 8'}, {'measure': 'Changes from Box and Block Test (BBT)', 'timeFrame': 'weekly test (from baseline to week 8)'}, {'measure': 'Changes from Engagement Questionnaire (EQ)', 'timeFrame': 'weekly test (from week 1 to week 8)'}, {'measure': 'Changes from Satisfactory Questionnaire (SQ)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from Building Tower Test (BTT)', 'timeFrame': 'weekly test (from baseline to week 8)'}, {'measure': 'Changes from String Beads Test (SBT)', 'timeFrame': 'weekly test (from baseline to week 8)'}, {'measure': 'Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Performance changes assessed by Kinematics Analysis', 'timeFrame': 'baseline, week 8, week 24', 'description': "Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks"}, {'measure': 'Changes from muscle strength', 'timeFrame': 'baseline, week 8, week 24', 'description': 'Measured by Electromyography (EMG)'}], 'secondaryOutcomes': [{'measure': 'Changes from Pediatric Evaluation of Disability Inventory (PEDI)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)', 'timeFrame': 'baseline, week 4, week 8, week 24'}, {'measure': 'Changes from Parenting Stress Index-Short Form (PSI-short)', 'timeFrame': 'baseline, week 4, week 8, week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy,', 'Upper limb neurorehabilitation', 'Upper Extremity', 'Neurological Rehabilitation'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP and children with CP with apparently one side affected. In addition, based on the ICF-CY model, comprehensive outcome measures including motor functions as well as psychological functions will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The inclusion criteria of this study are:\n\n1. aged between 3 and 16 years\n2. diagnosed with congenital hemiplegic or children with CP with one more affected side; (3) apparently disuse phenomenon of the more affected hand at spontaneous contexts\n\nParticipants will be exclude for:\n\n1. excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \\& Smith, 1987)\n2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation\n3. injections of botulinum toxin type A or operations on the UE within 6 months"}, 'identificationModule': {'nctId': 'NCT02808156', 'briefTitle': 'Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '201512070RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unilateral upper limbs intensive training', 'description': 'The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.', 'interventionNames': ['Other: unilateral upper limbs intensive training']}, {'type': 'EXPERIMENTAL', 'label': 'bilateral upper limbs intensive training', 'description': 'The bimanual intensive training focuses activities that required the use of both hands.', 'interventionNames': ['Other: bilateral upper limbs intensive training']}], 'interventions': [{'name': 'unilateral upper limbs intensive training', 'type': 'OTHER', 'description': 'The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.', 'armGroupLabels': ['unilateral upper limbs intensive training']}, {'name': 'bilateral upper limbs intensive training', 'type': 'OTHER', 'description': 'The bimanual intensive training focuses activities that required the use of both hands.', 'armGroupLabels': ['bilateral upper limbs intensive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Zhongzheng District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tien-Ni Wang', 'role': 'CONTACT', 'email': 'tnwang@ntu.edu.tw', 'phone': '886-2-33668163'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tien-Ni Wang', 'role': 'CONTACT', 'email': 'tnwang@ntu.edu.tw', 'phone': '886-2-33668163'}], 'overallOfficials': [{'name': 'Tien-Ni Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Occupational Therapy, School of Medicine, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}