Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-30 @ 1:12 PM
Study NCT ID:
NCT02751502
Status:
TERMINATED
Last Update Posted:
2022-02-11
First Post:
2016-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Based Adaptive Arm Training for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Renat.Sukhov@nyulangone.org', 'phone': '347-377-5138', 'title': 'Renat Sukhov, MD', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Study terminated prior to complete data collection.', 'eventGroups': [{'id': 'EG000', 'title': 'Whole Population', 'description': 'Data reported under one arm, as randomization into arms has not occurred yet.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Population', 'description': 'Data reported under one arm, as randomization into arms has not occurred yet.'}], 'timeFrame': '6 Weeks', 'description': 'Measure of impairments in motor functioning and recovery in children post hemiplegia.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prior to complete data collection'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Population', 'description': 'Data reported under one arm, as randomization into arms has not occurred yet.'}], 'timeFrame': '6 Weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prior to complete data collection'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whole Population', 'description': 'Data reported under one arm, as randomization into arms has not occurred yet.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of funding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Whole Population', 'description': 'Data reported under one arm, as randomization into arms has not occurred yet.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-25', 'size': 329426, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-10T14:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'lack of enrollment and funding + Covid-19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2016-04-19', 'resultsFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-10', 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale', 'timeFrame': '6 Weeks', 'description': 'Measure of impairments in motor functioning and recovery in children post hemiplegia.'}, {'measure': 'Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test', 'timeFrame': '6 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Children', 'Pediatrics', 'Arm', 'Upper limb', 'bimanual training', 'physical training'], 'conditions': ['Hemiplegia']}, 'descriptionModule': {'briefSummary': 'Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.\n\nThe specific aims of this proposal are to:\n\nAim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.\n\nAim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.\n\nIt is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acquired Brain Injury at least 3 months prior to enrollment.\n* Unilateral hemiparesis\n* History of compliance with home exercise programs in the past.\n\nExclusion Criteria:\n\n* Any social or medical problem that precludes compliance with the protocol\n* Comorbid seizure disorder or other neurological disease\n* Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment\n* Implanted neuromodulatory or electronic device or other complicating illness\n* Lack of capacity to consent'}, 'identificationModule': {'nctId': 'NCT02751502', 'briefTitle': 'Home Based Adaptive Arm Training for Children', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Home Based Adaptive Arm Training for Children With Hemiplegia', 'orgStudyIdInfo': {'id': '15-01326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimanual-to-unimanual device home training program', 'interventionNames': ['Device: m2 Bimanual Arm Trainer (BAT)']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional non-device home training program', 'description': 'Subjects receive 6 weeks of ongoing usual and customary care schedule of home physical and occupational therapy as usual and customary care independent of the study.'}], 'interventions': [{'name': 'm2 Bimanual Arm Trainer (BAT)', 'type': 'DEVICE', 'description': 'Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely', 'armGroupLabels': ['Bimanual-to-unimanual device home training program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Renat Sukhov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}