Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-31 @ 3:56 AM
Study NCT ID:
NCT01078766
Status:
UNKNOWN
Last Update Posted:
2016-04-08
First Post:
2010-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2010-02-28', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assisting Hand Assessment', 'timeFrame': 'twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program', 'description': 'Rasch built, it measures how effectively a child with unilateral disability typically makes use of their affected (assisting) hand during bimanual performance. It is conducted by a semi-structured play session requiring bimanual handling that is video-recorded. Scoring is performed by a analyzing the video on 22 predefined items using a 4-point criterion-referenced rating scale'}], 'secondaryOutcomes': [{'measure': 'Jebsen-Taylor Test of Hand Function', 'timeFrame': 'twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program'}, {'measure': 'The Pediatric Evaluation of Disability Inventory (PEDI)', 'timeFrame': 'twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program'}, {'measure': 'Muscle strength', 'timeFrame': 'twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral palsy'], 'conditions': ['Cerebral Palsy', 'Hand Function']}, 'descriptionModule': {'briefSummary': 'The combination of the constraint-induced movement therapy (CIMT) method as a complement to hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic CP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* active wrist extension/dorsiflexion of at least 20;\n* MACS 1-3;\n* GMFCS 1-2;\n* enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.\n\nExclusion criteria:\n\n* seizures;\n* severely increased muscle tone; or hemi arm to good;\n* orthopedic surgery on the upper extremity;\n* botulin toxin injections within the past half year to the upper extremity;\n* inability to understand instructions or cognitive/behavior/concentration.'}, 'identificationModule': {'nctId': 'NCT01078766', 'briefTitle': 'Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)', 'organization': {'class': 'OTHER', 'fullName': 'Alyn Pediatric & Adolescent Rehabilitation Hospital'}, 'officialTitle': 'Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP', 'orgStudyIdInfo': {'id': '920090440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIMT+HABIT', 'description': 'Form of "summer camp", for six hours per day for 10 consecutive work days.', 'interventionNames': ['Other: CIMT+HABIT']}], 'interventions': [{'name': 'CIMT+HABIT', 'type': 'OTHER', 'description': 'The daily schedule included one hour of constraining the functional arm with intensive activation of the hemi-paretic arm and then 5 hours of various structured, intensive bimanual functional activities,', 'armGroupLabels': ['CIMT+HABIT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}