Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01214902
Status:
UNKNOWN
Last Update Posted:
2011-06-21
First Post:
2010-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Constraint Induced Movement Therapy (CIMT) in Babies Home Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}, {'id': 'D010989', 'term': 'Play Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-10-04', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assistive Hand Assessment', 'timeFrame': 'after two months of treatment', 'description': 'Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemiplegia', 'Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '30760393', 'type': 'DERIVED', 'citation': 'Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.'}, {'pmid': '30307370', 'type': 'DERIVED', 'citation': 'Chamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '7 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy\n\nExclusion Criteria:\n\n* Epilepsy not treated'}, 'identificationModule': {'nctId': 'NCT01214902', 'briefTitle': 'Constraint Induced Movement Therapy (CIMT) in Babies Home Program', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'orgStudyIdInfo': {'id': 'chamudotctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental CIMT', 'description': 'Two month home program that includes restricting the non hemiplegic hand an hour a day during play', 'interventionNames': ['Device: Constraint induced movement therapy (CIMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Play', 'description': 'Two month home program that includes active use of hemiplegic hand during play one hour a day', 'interventionNames': ['Behavioral: play']}], 'interventions': [{'name': 'Constraint induced movement therapy (CIMT)', 'type': 'DEVICE', 'otherNames': ['Modifide constraint induced movoment therapy'], 'description': 'soft mitten worn on the non hemiplegic hand', 'armGroupLabels': ['Experimental CIMT']}, {'name': 'play', 'type': 'BEHAVIORAL', 'description': 'play which encourages the use of the hemiplegic hand', 'armGroupLabels': ['Active Play']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Varda Gross-Tzur, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ShaareZMC', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Rena Shara chamudot, Ms.c', 'role': 'CONTACT', 'email': 'chamudot@012.net.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Gross- Tsur Varda', 'oldOrganization': 'SHAARE ZEDEK MEDICAL CENTER'}}}}