Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-23 @ 8:30 AM
Study NCT ID:
NCT01967004
Status:
UNKNOWN
Last Update Posted:
2014-03-05
First Post:
2013-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Upper Limb Prostheses With Radio Frequency Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-10-17', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time required to perform different functional tasks', 'timeFrame': '12 weeks', 'description': 'Each participant will perform functional tests on the first visit. These tests consist of moving objects from one location to another, and performing certain muscle contraction patterns when prompted. The participant will then take the prosthesis, installed with morph, home for 3 months at most, and then return to perform another set of timed trials.'}], 'secondaryOutcomes': [{'measure': 'Questionnaires on prosthesis function and satisfaction', 'timeFrame': '20 minutes per questionnaire, total of 3 different questionnaires administered twice each', 'description': 'The questionnaires offer the participant the opportunity to express their experience and satisfaction with their prosthesis, during different tasks and at home.'}]}, 'conditionsModule': {'conditions': ['Below Elbow Amputation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or greater.\n2. Below elbow amputation, unilateral or bilateral.\n3. Chronic stable amputation: \\> 6 months from amputation.\n4. Stable prosthesis prescription: \\> 3 months since last major prosthesis modification.\n5. Cognitively intact, as determined by Mini-Mental Status Examination score \\> 24.\n6. Able to provide informed consent and available to participate in study activities.\n7. No severe residual limb motor/sensory impairment or pain likely to interfere with treatment.\n8. Expected to be medically and psychiatrically stable for study duration.\n\nExclusion Criteria:\n\n1. Patients with diseases which weaken and/or adversely affect the control of skeletal muscle.\n2. Patients with poor skin integrity.'}, 'identificationModule': {'nctId': 'NCT01967004', 'acronym': 'RFIDIBT', 'briefTitle': 'Enhancing Upper Limb Prostheses With Radio Frequency Identification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infinite Biomedical Technologies'}, 'officialTitle': 'Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)', 'orgStudyIdInfo': {'id': 'RFID-IBT-3600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional Assessment', 'description': 'Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects.', 'interventionNames': ['Device: Morph']}], 'interventions': [{'name': 'Morph', 'type': 'DEVICE', 'otherNames': ['Myoelectrically-Operated RFID Prosthetic Hand'], 'description': 'Morph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment.', 'armGroupLabels': ['Functional Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218-3637', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Eastern Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Eastern Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infinite Biomedical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}