Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-19 @ 9:12 PM
Study NCT ID:
NCT03647761
Status:
TERMINATED
Last Update Posted:
2022-07-05
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Covid19, lack of manpower', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assisting Hand Assessment (AHA)', 'timeFrame': 'At the end of standard OT sessions usually lasting 3 months.', 'description': 'AHA measures hand function evaluation for children with unilateral upper limb disabilities'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tetra-grip', 'Assisting Hand Assessment'], 'conditions': ['Neonatal Brachial Plexus Palsy']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of wearing a tetra-grip on the affected arm of children with neonatal brachial plexus palsy. Half of the participants will have tetra-grip applied to the arm, while the other half will not have it applied to the arm.', 'detailedDescription': 'Tetra-grip is a tubular elastic support bandage that provides both compression and support. Previous studies have shown that by applying neoprene or athletic tape to a joint on individuals with poor proprioception or a history of joint injury, such modalities enhanced their proprioceptive recognition via stimulation of mechanoreceptors responding to skin stretch and compression during joint motion. As a result, patients have greater kinesthetic and joint position awareness of their limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 - 7 years old\n* male or female\n* non-dominant upper extremity brachial plexus injury\n\nExclusion Criteria:\n\n* Botox injections to the affected extremity within the past 3 months\n* Severe muscle contractures of affected extremity that restricts functional use of the arm and hand\n* Concurrent cerebral palsy'}, 'identificationModule': {'nctId': 'NCT03647761', 'briefTitle': 'Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?', 'orgStudyIdInfo': {'id': 'STU 022018-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Tetra-grip applied', 'interventionNames': ['Device: Tetra-grip']}], 'interventions': [{'name': 'Tetra-grip', 'type': 'DEVICE', 'description': 'Tetra-grip is a tubular elastic bandage that provides both compression and support', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Rinaldi', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}