Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06284005
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000673', 'term': 'Amputation, Traumatic'}, {'id': 'D007869', 'term': 'Leg Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ad hoc check-list Adverse Event', 'timeFrame': 'baseline', 'description': 'questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.'}, {'measure': 'ad hoc check-list Adverse Event', 'timeFrame': 'day 2', 'description': 'questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.'}, {'measure': 'ad hoc check-list Adverse Event', 'timeFrame': 'day 3', 'description': 'questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.'}, {'measure': 'ad hoc check-list Adverse Event', 'timeFrame': 'day 4', 'description': 'questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.'}, {'measure': 'ad hoc check-list Adverse Event', 'timeFrame': 'day 5', 'description': 'questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lower limb', 'transfemoral'], 'conditions': ['Amputation', 'Traumatic Amputation', 'Leg Injury', 'Lower Limb Injury']}, 'referencesModule': {'references': [{'pmid': '18566923', 'type': 'BACKGROUND', 'citation': 'Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.'}, {'pmid': '11392649', 'type': 'BACKGROUND', 'citation': 'Mak AF, Zhang M, Boone DA. State-of-the-art research in lower-limb prosthetic biomechanics-socket interface: a review. J Rehabil Res Dev. 2001 Mar-Apr;38(2):161-74.'}, {'pmid': '25197716', 'type': 'BACKGROUND', 'citation': 'Pirouzi G, Abu Osman NA, Eshraghi A, Ali S, Gholizadeh H, Wan Abas WA. Review of the socket design and interface pressure measurement for transtibial prosthesis. ScientificWorldJournal. 2014;2014:849073. doi: 10.1155/2014/849073. Epub 2014 Aug 13.'}, {'pmid': '17436172', 'type': 'BACKGROUND', 'citation': 'Segal AD, Orendurff MS, Klute GK, McDowell ML, Pecoraro JA, Shofer J, Czerniecki JM. Kinematic and kinetic comparisons of transfemoral amputee gait using C-Leg and Mauch SNS prosthetic knees. J Rehabil Res Dev. 2006 Nov-Dec;43(7):857-70. doi: 10.1682/jrrd.2005.09.0147.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.\n\nThe main question it aims to answer are:\n\n* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.\n* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.\n\nParticipants will perform:\n\n* walking tests inside parallel bars on flat and/or inclined terrain;\n* walking tests on treadmill;\n* stair climbing/descent tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trans femoural amputation\n* Medicare Functional Classification Levels k3-k4\n* expert prosthesis wearer (more than one year)\n* electronic knee prostheses user\n* energy-release prosthetic foot user\n\nExclusion Criteria:\n\n* Relevant medical comorbidities\n* heart device wearers (PMK or AICD)\n* cognitive impairment\n* anxious or depressed illness'}, 'identificationModule': {'nctId': 'NCT06284005', 'acronym': 'MOTU-ATP', 'briefTitle': 'Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level', 'orgStudyIdInfo': {'id': 'MOTU ATP - Studio clinico'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prosthetic group', 'description': 'prosthetic group performs the entire protocol with the prosthesis prototype.', 'interventionNames': ['Device: WRL ATP']}], 'interventions': [{'name': 'WRL ATP', 'type': 'DEVICE', 'description': 'evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype', 'armGroupLabels': ['prosthetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50143', 'city': 'Florence', 'state': 'FI', 'country': 'Italy', 'facility': 'IRCCS Fondazione Don Carlo Gnocchi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'claudio macchi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Fondazione Don Carlo Gnocchi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Claudio Macchi', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}