Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 8:34 AM
Study NCT ID:
NCT01076257
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2010-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}, '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': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-30', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week', 'description': 'All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.'}, {'measure': 'Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week'}, {'measure': 'Kinematic analysis', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week'}], 'secondaryOutcomes': [{'measure': 'Pediatric Motor Activity Log ( PMAL )', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week', 'description': 'All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.'}, {'measure': 'Pediatric Functional Independence Measure ( WeeFIM )', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week'}, {'measure': 'Cerebral palsy quality of life (CPQoL)', 'timeFrame': '4 weeks (post-treatment), 12 week, 24 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brain damage', 'constraint induced movement therapy', 'kinematic', 'function', 'outcome', 'Quality of life'], 'conditions': ['Brain Damage', 'Cerebral Palsy', 'Traumatic Brain Damage']}, 'descriptionModule': {'briefSummary': 'This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.', 'detailedDescription': '"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage.\n\nThis well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Development learned-nonuse\n2. Age range 4y/o-15y/o\n3. Wrist ext 10˚, MP j't ext 10˚ in affected U/E\n4. Can fallow up the simple instruction\n5. Modified Ashworth Scale ≦2\n6. Pediatric Motor Activity Log ≦2.5 (average)\n\nExclusion Criteria:\n\n1. Related muscle skeleton surgery\n2. Selective dorsal rhizotomy\n3. Botulinum toxin in 6 months\n4. Visual perception impaired\n5. Hearing perception impaired\n6. Balance ability impaired (in constrained)"}, 'identificationModule': {'nctId': 'NCT01076257', 'briefTitle': 'Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study', 'orgStudyIdInfo': {'id': '97-1823B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Constraint-induced Movement Therapy', 'interventionNames': ['Behavioral: Modified Constraint-induced Movement Therapy']}, {'type': 'OTHER', 'label': 'Transditional rehabilitation', 'interventionNames': ['Behavioral: Modified Constraint-induced Movement Therapy']}], 'interventions': [{'name': 'Modified Constraint-induced Movement Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Constraint-Induced Therapy', 'Forced-use Therapy', 'Immobilization Therapy'], 'description': 'Home based CIT\n\n1. Restriction of the less affected limb\n2. Intensive practice using affected limb\n3. Positive experience\n4. Functional task (task)', 'armGroupLabels': ['Constraint-induced Movement Therapy', 'Transditional rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Chia-Ling chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}