Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 8:14 PM
Study NCT ID:
NCT00305006
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2006-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D006184', 'term': 'Habits'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ag275@columbia.edu', 'phone': '212-678-3326', 'title': 'Dr. Andrew Gordon', 'organization': 'Teachers College, Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Both groups receive treatment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CIMT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HABIT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Score on Assisting Hand Assessment (AHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CIMT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.'}, {'id': 'OG001', 'title': 'HABIT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.76'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.90'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'pValueComment': 'ANOVA', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1', 'groupDescription': 'ANOVA', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.', 'unitOfMeasure': 'score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject sample size calculation based on prior data. intention to treat (ITT) was used.'}, {'type': 'PRIMARY', 'title': 'Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CIMT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.'}, {'id': 'OG001', 'title': 'HABIT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.'}], 'classes': [{'categories': [{'measurements': [{'value': '-141.7', 'groupId': 'OG000', 'lowerLimit': '-195.4', 'upperLimit': '-88.0'}, {'value': '-131.2', 'groupId': 'OG001', 'lowerLimit': '-185.0', 'upperLimit': '-77.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.', 'unitOfMeasure': 'score', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CIMT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.'}, {'id': 'FG001', 'title': 'HABIT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failure to complete pretest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from clinics in the NYC area, and online support groups from June 2007 to July 2009. Participants were firs screened via e-mail and/or telephone and potentially invited to receive an on-site physical examination or an examination videotaped by their physical occupational therapist.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CIMT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.'}, {'id': 'BG001', 'title': 'HABIT', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '1.11', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2006-03-20', 'resultsFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2006-03-20', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-06', 'studyFirstPostDateStruct': {'date': '2006-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Score on Assisting Hand Assessment (AHA)', 'timeFrame': 'Baseline, 6 months', 'description': 'The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.'}, {'measure': 'Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)', 'timeFrame': 'Baseline, 6 months', 'description': 'The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'constraint-induced therapy', 'constraint-induced movement therapy', 'CP', 'hemiplegia', 'hand', 'forced use', 'motor control', 'children', 'HABIT', 'Hand-arm bimanual intensive therapy', 'Bilateral training', 'Bimanual training', 'functional therapy', 'physical therapy', 'occupational therapy', 'intensive', 'pediatric', 'development', 'upper extremity', 'hemiplegic'], 'conditions': ['Cerebral Palsy', 'Hemiplegia', 'Children', 'Pediatric']}, 'referencesModule': {'references': [{'pmid': '17044964', 'type': 'BACKGROUND', 'citation': 'Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.'}, {'pmid': '16836774', 'type': 'BACKGROUND', 'citation': 'Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42. doi: 10.1017/S0012162206001356.'}, {'pmid': '16510616', 'type': 'BACKGROUND', 'citation': 'Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.'}, {'pmid': '17979861', 'type': 'BACKGROUND', 'citation': 'Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.'}, {'pmid': '18224309', 'type': 'BACKGROUND', 'citation': 'Steenbergen B, Charles J, Gordon AM. Fingertip force control during bimanual object lifting in hemiplegic cerebral palsy. Exp Brain Res. 2008 Mar;186(2):191-201. doi: 10.1007/s00221-007-1223-6. Epub 2008 Jan 26.'}, {'pmid': '19087099', 'type': 'BACKGROUND', 'citation': 'Schertz M, Gordon AM. Changing the model: a call for a re-examination of intervention approaches and translational research in children with developmental disabilities. Dev Med Child Neurol. 2009 Jan;51(1):6-7. doi: 10.1111/j.1469-8749.2008.03220.x. No abstract available.'}, {'pmid': '19160464', 'type': 'BACKGROUND', 'citation': 'Gordon AM, Chinnan A, Gill S, Petra E, Hung YC, Charles J. Both constraint-induced movement therapy and bimanual training lead to improved performance of upper extremity function in children with hemiplegia. Dev Med Child Neurol. 2008 Dec;50(12):957-8. doi: 10.1111/j.1469-8749.2008.03166.x. No abstract available.'}, {'pmid': '21715141', 'type': 'BACKGROUND', 'citation': 'Hung YC, Casertano L, Hillman A, Gordon AM. The effect of intensive bimanual training on coordination of the hands in children with congenital hemiplegia. Res Dev Disabil. 2011 Nov-Dec;32(6):2724-31. doi: 10.1016/j.ridd.2011.05.038. Epub 2011 Jun 28.'}, {'pmid': '21700924', 'type': 'RESULT', 'citation': 'Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.'}], 'seeAlsoLinks': [{'url': 'http://www.tc.edu/centers/cit/', 'label': 'Center for cerebral palsy research'}]}, 'descriptionModule': {'briefSummary': 'A randomized control trial of bimanual training. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy.', 'detailedDescription': 'A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. We have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '30 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nwillingness to agree to intervention and testing procedures and travel to the University for participation and testing.\n\nExclusion Criteria:\n\n* health problems not associated with CP\n* uncontrollable seizures\n* visual problems that would interfere with carrying out the intervention or testing\n* botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study'}, 'identificationModule': {'nctId': 'NCT00305006', 'briefTitle': 'Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Teachers College, Columbia University'}, 'officialTitle': 'Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': '08126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIMT Intervention', 'description': 'Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.', 'interventionNames': ['Procedure: Constraint-Induced Movement Therapy (CIMT)']}, {'type': 'EXPERIMENTAL', 'label': 'HABIT Intervention', 'description': 'Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.', 'interventionNames': ['Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)']}], 'interventions': [{'name': 'Constraint-Induced Movement Therapy (CIMT)', 'type': 'PROCEDURE', 'description': '90 hours', 'armGroupLabels': ['CIMT Intervention']}, {'name': 'Hand-Arm Bimanual Intensive Therapy (HABIT)', 'type': 'PROCEDURE', 'description': '90 hours', 'armGroupLabels': ['HABIT Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Teachers College, Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrew M Gordon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teachers College, Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrew Gordon', 'investigatorAffiliation': 'Columbia University'}}}}