Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04709367
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2021-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual limb volume changes', 'timeFrame': 'The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks', 'description': 'Residual limb volume changes due to prosthesis doffing, physical activity, and testing time are measured by a proper experimental set-up, including a 3D metrology-grade optical scanner.'}], 'secondaryOutcomes': [{'measure': 'Pressure distribution at the prosthetic socket - residual limb interface', 'timeFrame': 'The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks', 'description': 'Pressure distributions at the residual limb/ socket interface are measured by the F-Socket Pressure Measurement System, during:\n\n* Walking (five gait cycles, three times);\n* Walking up and down slope (five gait cycles, three times);\n* Walking upstairs and downstairs (six stairs cycles, three times);\n* Sitting down and up (three times).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amputee', 'Prosthetic socket', 'Transfemoral residual limb', 'Volume change', '3D scan'], 'conditions': ['Amputation Stump']}, 'referencesModule': {'references': [{'pmid': '37379468', 'type': 'DERIVED', 'citation': 'Paterno L, Truppa L, Ibrahimi M, Rosini E, Gruppioni E, Ricotti L, Menciassi A. Quantitative analysis of interface pressures in transfemoral prosthetic sockets. Prosthet Orthot Int. 2024 Apr 1;48(2):176-183. doi: 10.1097/PXR.0000000000000251. Epub 2023 Jun 28.'}, {'pmid': '34112873', 'type': 'DERIVED', 'citation': 'Paterno L, Ibrahimi M, Rosini E, Menfi G, Monaco V, Gruppioni E, Ricotti L, Menciassi A. Residual limb volume fluctuations in transfemoral amputees. Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.'}]}, 'descriptionModule': {'briefSummary': 'This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.', 'detailedDescription': 'The first test session aims at measuring residual limb volume at 7 time-points, with 10 minute intervals, after prosthesis doffing. This allows for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee are captured to evaluate volume changes due to prosthesis removal and physical activity, in two times per day (one in the morning, one in the afternoon). These measurements are repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'transfemoral amputees', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stabilized (i.e., time since amputation \\> 18 months) transfemoral amputees\n* Age between 18 and 65 years old\n* Subjects able to safely perform the physical tasks required in the experimental protocol\n* Subjects provided with prostheses\n\nExclusion Criteria:\n\n* Denial of informed consent to participate in the study\n* Inability to maintain the required position during the 3D scanning for at least 5 minutes\n* Concomitant general or localized comorbidities / disabilities, which may interfere with the study\n* Pathological conditions affecting the residual limb\n* Allergy / sensitivity with polydimethylsiloxane (PDMS)\n* Pathological cardiopulmonary / cardiovascular conditions\n* Pregnancy or breastfeeding\n* Presence of psychiatric co-morbidities\n* Presence of cognitive deficits which may compromise the understanding of the required tasks\n* Difficulty in understanding the Italian language\n* Insufficient degree of collaboration\n* Consumption of alcohol or diuretics before tests'}, 'identificationModule': {'nctId': 'NCT04709367', 'briefTitle': 'Characterization of Residual Limb Volume Changes in Transfemoral Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro'}, 'officialTitle': 'Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.', 'orgStudyIdInfo': {'id': 'P-PPRAI1/2-01'}}, 'armsInterventionsModule': {'interventions': [{'name': '3D optical scan', 'type': 'OTHER', 'description': "The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon."}]}, 'contactsLocationsModule': {'locations': [{'zip': '40054', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'INAIL Prosthesis Centre', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Emanuele Gruppioni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INAIL Prosthesis Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro', 'class': 'OTHER'}, 'collaborators': [{'name': "Scuola Superiore Sant'Anna di Pisa", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}