Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-05 @ 6:56 PM
Study NCT ID:
NCT06599060
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trinity Amputation and Prosthetic Experience Scales (TAPES)', 'timeFrame': '0-1 years', 'description': 'It will be used to evaluate the prosthetic experience.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with the Prosthesis (SATPRO) Questionnaire', 'timeFrame': '0-1 years', 'description': 'It will be used to assess denture satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transtibial amputees', 'prosthesis satisfaction', 'prosthesis experience'], 'conditions': ['Transtibial Amputation - Unilateral']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.medipol.edu.tr/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p\\<0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p\\<0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P \\<0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p\\<0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p\\>0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18-75\n* unilateral below knee amputation\n* volunteer to participate\n* have been using a transtibial prosthesis for at least one year\n* can read and understand Turkish.\n\nExclusion Criteria:\n\n* muscle strength and sensory loss in the intact extremity that may affect ambulation\n* upper limb amputees\n* congenital amputees\n* bilateral amputees\n* mentally disabled\n* with neurological disease'}, 'identificationModule': {'nctId': 'NCT06599060', 'briefTitle': 'Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees', 'orgStudyIdInfo': {'id': 'YaziciH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trinity Amputation and Prosthesis Experience Scale', 'type': 'OTHER', 'otherNames': ['Satisfaction with Prosthesis Questionnaire'], 'description': 'Participants were administered a questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34290', 'city': 'Beykoz', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol University', 'geoPoint': {'lat': 41.14389, 'lon': 29.09056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Hande YAZICI', 'investigatorAffiliation': 'Medipol University'}}}}