Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04354493
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myoelectric Game Training and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'South Hampton Hand Assesment', 'timeFrame': '6 week periods', 'description': 'Hand functional test'}], 'secondaryOutcomes': [{'measure': 'Static Tracking Test', 'timeFrame': '6 week periods', 'description': 'Myo-electric reach and hold measure.'}, {'measure': 'Dynamic Tracking Test', 'timeFrame': '6 week periods', 'description': 'Myo-electric signal path tracing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['myoelectric', 'training', 'upper limb', 'prosthetics', 'video games'], 'conditions': ['Amputation', 'Prosthesis User', 'Prosthesis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.', 'detailedDescription': 'Participants will undergo informed consent and schedule an initial site visit. A logging device will be used to track activity of prosthetic arm usage while in everyday use at home. After a baseline period, participants will schedule a second visit to be introduced to the training technology.\n\nThe study will span up to 7 months with participants training at home for 15-60 minutes, 3-5 times a day. Every 3-6 weeks, investigators will schedule a study event and sit visit to conduct functional outcome tasks and measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* User of upper-limb myo-prosthesis or able to wear prosthesis simulator\n* The subjects must be able to read, write, and speak English in order to be properly consented and to express their thoughts to the study personnel, and they must be willing and able to complete the activities outlined in the study.\n\nExclusion Criteria:\n\n* The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT04354493', 'briefTitle': 'Myoelectric Game Training and Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Liberating Technologies, Inc.'}, 'officialTitle': 'Myoelectric Game Training and Outcomes', 'orgStudyIdInfo': {'id': 'A-20729'}, 'secondaryIdInfos': [{'id': '120180273', 'type': 'OTHER', 'domain': 'NEIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baseline and Training', 'description': 'This group consists of a baseline and training conditions only.', 'interventionNames': ['Device: Myo-electric Gaming Interface']}, {'type': 'EXPERIMENTAL', 'label': 'Baseline, Training, and Control', 'description': 'This group stops training condition sooner and returns to a control to evaluate carry-over effects.', 'interventionNames': ['Device: Myo-electric Gaming Interface']}], 'interventions': [{'name': 'Myo-electric Gaming Interface', 'type': 'DEVICE', 'otherNames': ['MEGI'], 'description': 'Non-significant risk, video game controller which maps myo-electric control signals to button presses.', 'armGroupLabels': ['Baseline and Training', 'Baseline, Training, and Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01746', 'city': 'Holliston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Liberating Technologies Inc.', 'geoPoint': {'lat': 42.2001, 'lon': -71.4245}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liberating Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}