Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT03765034
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2018-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076984', 'term': 'Neonatal Brachial Plexus Palsy'}], 'ancestors': [{'id': 'D020516', 'term': 'Brachial Plexus Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001720', 'term': 'Birth Injuries'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assisting Hand Assessment 5.0', 'timeFrame': 'change from baseline at 8 weeks and 16 weeks', 'description': 'Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Brachial Plexus Palsy']}, 'descriptionModule': {'briefSummary': 'This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.', 'detailedDescription': 'Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.\n\nConstraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has perinatal brachial plexus injury\n* Participant walking at time of study inception\n* Ability to cooperate with interventions and assessment\n* Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study\n\nExclusion Criteria:\n\n* Co-morbid diagnosis not related to perinatal brachial plexus injury\n* Flaccidity of the involved upper extremity or no observable hand function\n* Planned surgery or drug intervention during the study period\n* Allergy or intolerance to constraint intervention materials'}, 'identificationModule': {'nctId': 'NCT03765034', 'briefTitle': 'Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'CCI-10-00255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Constraint-induced Movement Therapy', 'description': "A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.", 'interventionNames': ['Behavioral: Constrain-induced Movement Therapy', 'Behavioral: Usual Occupational Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Occupational Therapy', 'description': 'Usual and standard care occupational therapy is administered for 8 weeks.', 'interventionNames': ['Behavioral: Usual Occupational Therapy']}], 'interventions': [{'name': 'Constrain-induced Movement Therapy', 'type': 'BEHAVIORAL', 'description': '8-week therapy program utilizing constraint of the unaffected arm', 'armGroupLabels': ['Constraint-induced Movement Therapy']}, {'name': 'Usual Occupational Therapy', 'type': 'BEHAVIORAL', 'description': '8-week therapy program without constraint of the unaffected arm', 'armGroupLabels': ['Constraint-induced Movement Therapy', 'Usual Occupational Therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Scientist', 'investigatorFullName': 'julie werner', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}