Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-05 @ 12:14 PM
Study NCT ID:
NCT01413594
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2011-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bimanual Training in Children With Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D006184', 'term': 'Habits'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}, {'id': 'D009788', 'term': 'Occupational Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in quality of bimanual hand use at 12 months', 'timeFrame': '12 months', 'description': 'Changes in quality of how the two hands are used during manual activity as determined from video analysis.'}, {'measure': 'Change from baseline in manual dexterity at 12 months', 'timeFrame': '12 months', 'description': 'Change from baseline in timed performance of standardized manual activities'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in upper extremity strength at 12 months', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in range of upper extremity motion at 12 months', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in goal achievement at 12 months', 'timeFrame': '12 months', 'description': 'Change in caregiver ratings of activities identified as important goals by the caregiver'}]}, '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', 'childhood stroke'], 'conditions': ['Hemiplegia', 'Cerebral Palsy', 'Children']}, 'referencesModule': {'references': [{'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': 'BACKGROUND', '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.'}, {'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': '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': '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': '19811524', 'type': 'BACKGROUND', 'citation': 'Gordon AM. Two hands are better than one: bimanual skill development in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2010 Apr;52(4):315-6. doi: 10.1111/j.1469-8749.2009.03390.x. Epub 2009 Oct 7. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.tc.edu/centers/cit/', 'label': 'Center for Cerebral Palsy Research, TC, Columbia University'}]}, 'descriptionModule': {'briefSummary': 'A randomized control trial of bimanual training in children with hemiplegia. 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. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.', '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 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators developed HABIT in 2004 as an alternative to constraint-therapy that avoids use of a restraint. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The investigators 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': '16 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\*willingness 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': 'NCT01413594', 'acronym': 'HABIT', 'briefTitle': 'Bimanual Training in Children With Hemiplegia', 'organization': {'class': 'OTHER', 'fullName': 'Teachers College, Columbia University'}, 'officialTitle': 'Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)', 'orgStudyIdInfo': {'id': '11204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HABIT', 'description': 'Hand-Arm Bimanual Intensive Therapy (HABIT)', 'interventionNames': ['Behavioral: HABIT']}, {'type': 'NO_INTERVENTION', 'label': 'Ongoing usual and customary rehabilitation care', 'description': 'Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT.'}], 'interventions': [{'name': 'HABIT', 'type': 'BEHAVIORAL', 'otherNames': ['constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy'], 'description': '90 hours of bimanual training over 3 weeks in a day camp environment', 'armGroupLabels': ['HABIT']}]}, '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, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teachers College, Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teachers College, Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrew Gordon', 'investigatorAffiliation': 'Columbia University'}}}}