Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-31 @ 2:32 PM
Study NCT ID:
NCT02666859
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Prosthetic Training and Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Virtual Reality Prosthetic Training'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Angle Range of Motion', 'timeFrame': '2 hours', 'description': 'Using a motion capture system, joint angle measurements will be taken throughout the sessions while the subject completes the tasks.'}], 'secondaryOutcomes': [{'measure': 'Movement Symmetry', 'timeFrame': '2 hours', 'description': 'Using a motion capture system and the joint angle measurements, the movement symmetry of the arms will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amputation of Upper Limb']}, 'descriptionModule': {'briefSummary': 'The proposed project is to develop an effective prosthetic training and rehabilitation regimen, with the use of virtual reality, to return patients to the highest level of independence and functioning possible. The Computer Assisted Rehabilitation Environment (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life situations while providing real time visual feedback of their motion to improve the training and rehabilitation of upper limb prosthetic users.', 'detailedDescription': "The subjects will be asked to participate in two 1-2 hour sessions to test the range of motion (ROM), activities of daily living ( ADL) and return to duty tasks (RTD) tasks with and without the use of virtual reality. All amputee subjects will be required to wear their same preferred prosthetic device for all sessions. The ROM tasks include, elbow flexion/extension, forearm pronation/supination, shoulder flexion/extension, shoulder abduction/adduction, shoulder rotation, torso flexion/extension, torso lateral flexion, and torso rotation. The ADL tasks would include a series of tasks to encompass typical actives one would encounter on a daily basis such as, drinking from a cup, bilateral and unilateral lift tasks, and a reach and grasp test. The RTD tasks would include a series of simple tasks service members typically perform in their daily work routine such as donning and doffing a jacket and helmet, packing and unpacking a rucksack, and carrying a weapon.\n\nThe subjects will be asked to complete each task three times. Prior to performing a task, when participating in the virtual reality session, the task will be demonstrated on the virtual screen with an animated model. The motion of the animated model will be determined by previously collected data to accurately predict the correct motion for each individual. An avatar of the subject will then be shown on the screen to display the real time motion. The reflective markers that were strategically placed on the subject will be connected to the corresponding joint on the virtual avatar to accurately animate the real time motion of the subject on the virtual screen. The demonstrated model will be shown simultaneously with the real time avatar to show the accuracy of the subject's performance in relation to the individualized predicted optimized motion. This will provide instant visual feedback to the subject."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with unilateral transhumeral or transradial amputation\n* uses body-powered or myoelectric prosthetic device.\n* free of any health aliment that would impair physical function\n* must not have any injuries or surgeries on the affected limb within the past 90 days.\n* Subjects ,just be able to perform activities of daily living without assistance'}, 'identificationModule': {'nctId': 'NCT02666859', 'briefTitle': 'Virtual Reality Prosthetic Training and Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'The Use of Virtual Reality to Enhance Upper Limb Prosthetic Training and Rehabilitation', 'orgStudyIdInfo': {'id': 'Pro00016934'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral Transradial Amputation', 'description': 'This group includes people with a unilateral transradial amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'EXPERIMENTAL', 'label': 'Unilateral Transhumeral Amputation', 'description': 'This group includes people with a unilateral transhumeral amputation. Potential subjects must use a body-powered or myoelectric prosthetic device. This group will be exposed to virtual reality therapy and non-virtual reality therapy.', 'interventionNames': ['Device: Virtual Reality']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'During this intervention, the subjects will be immersed in a virtual reality system called the Computer Assisted Rehabilitation Environment (CAREN) system to complete the tasks.', 'armGroupLabels': ['Unilateral Transhumeral Amputation', 'Unilateral Transradial Amputation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Ashley Knight, M.S. BME', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}, {'name': 'Stephanie Carey, Ph.D. BME', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, {'name': 'Telemedicine & Advanced Technology Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Stephanie L. Carey', 'investigatorAffiliation': 'University of South Florida'}}}}