Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 6:43 PM
Study NCT ID:
NCT04326712
Status:
UNKNOWN
Last Update Posted:
2020-03-30
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Measurement-manufacturing Techniques on Load Distribution in 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': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of load distrubution on stump in conventional manufactured socket', 'timeFrame': 'Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking', 'description': 'Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.'}, {'measure': 'Measurement of load distrubution on stump in 3D manufactured socket', 'timeFrame': 'Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking', 'description': 'Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.'}, {'measure': 'Measurement of load distrubution on stump in conventional manufactured socket', 'timeFrame': 'Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.', 'description': 'Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.'}, {'measure': 'Measurement of load distrubution on stump in 3D-manufactured socket', 'timeFrame': 'Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs', 'description': 'Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs'}, {'measure': 'Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket', 'timeFrame': 'Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking', 'description': 'Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking'}, {'measure': 'Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket', 'timeFrame': 'Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking', 'description': 'Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking'}, {'measure': 'Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket', 'timeFrame': 'Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs', 'description': 'Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs'}, {'measure': 'Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket', 'timeFrame': 'Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs', 'description': 'Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amputee, loading, 3D'], 'conditions': ['Transtibial Amputee', 'Loading', 'Conventional', '3D']}, 'referencesModule': {'references': [{'pmid': '16919376', 'type': 'BACKGROUND', 'citation': 'Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.'}, {'pmid': '19127605', 'type': 'BACKGROUND', 'citation': 'Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.'}, {'pmid': '17281865', 'type': 'BACKGROUND', 'citation': 'Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.'}, {'pmid': '9184457', 'type': 'BACKGROUND', 'citation': 'Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.'}]}, 'descriptionModule': {'briefSummary': 'Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. 3D method is accepted as an effective and reliable method in prosthetic socket production. The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unilateral transtibial amputees', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being unilateral transtibial amputation\n* To have enough perception level to understand and apply commands\n\nExclusion Criteria:\n\n* To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait\n* The presence of pain that will affect the posture or walking pattern\n* Wound / tenderness on the stump\n* Visual impairment that will affect the posture or gait pattern\n* Use of any assistive device (walking stick, canary, etc.) during walking'}, 'identificationModule': {'nctId': 'NCT04326712', 'briefTitle': 'The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses', 'orgStudyIdInfo': {'id': '09.2019.359'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Unilateral transtibial amputees using conventinional manufactured socket', 'interventionNames': ['Other: conventional manufactured socket']}, {'label': 'Group 2', 'description': 'Unilateral transtibial amputees using 3D manufactured socket', 'interventionNames': ['Other: 3D manufactured socket']}], 'interventions': [{'name': 'conventional manufactured socket', 'type': 'OTHER', 'description': 'Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees', 'armGroupLabels': ['Group 1']}, {'name': '3D manufactured socket', 'type': 'OTHER', 'description': 'Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'yasar tatar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}