Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-28 @ 2:27 AM
Study NCT ID:
NCT06700668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Knee Prosthesis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic cost', 'timeFrame': 'An average of 2 sessions in the span of 1 week', 'description': "Effort of participants' walking measured via metabolic cost, which is measured using an mask that measures the Oxygen and Carbon dioxide levels."}], 'secondaryOutcomes': [{'measure': 'Ground reaction force', 'timeFrame': 'An average of 2 sessions in the span of 1 week', 'description': 'Ground reaction forces will be measured via force plates on the ground.'}, {'measure': 'Gait kinematics', 'timeFrame': 'An average of 2 sessions in the span of 1 week', 'description': 'Motion capture data will be collected using a validated system (e.g., Vicon, or similar motion capture software). Reflective markers will be placed on anatomical landmarks following a standard gait model. Kinematic measures, including joint angles (hip, knee, and ankle), step length, stride length, cadence, and walking speed, will be derived.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Transfemoral Amputation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female age 22-65.\n* The patient must have a unilateral transfemoral amputation .\n* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).\n* The patient must have adequate socket to support the device.\n\nExclusion Criteria:\n\n* Women who are pregnant.\n* Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \\>40, etc.).'}, 'identificationModule': {'nctId': 'NCT06700668', 'briefTitle': 'Active Knee Prosthesis Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Institute of Technology'}, 'officialTitle': 'Active Knee Prosthesis Study', 'orgStudyIdInfo': {'id': '0804002682'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIT Powered Knee', 'description': 'Subjects wears the MIT powered knee prosthesis.', 'interventionNames': ['Device: MIT Powered Knee']}, {'type': 'NO_INTERVENTION', 'label': 'Prescribed prosthesis', 'description': 'Subjects wears their prescribed prosthesis.'}], 'interventions': [{'name': 'MIT Powered Knee', 'type': 'DEVICE', 'description': 'MIT powered knee prosthesis developed by the MIT Biomechatronics Group.', 'armGroupLabels': ['MIT Powered Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MIT Media Lab', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Hugh Herr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Institute of Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Subject confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}