Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-18 @ 11:42 PM
Study NCT ID:
NCT05850104
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Classical Prosthesis and Silicone Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000673', 'term': 'Amputation, Traumatic'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'through study completion, an average of one and a half months', 'description': 'All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).'}, {'measure': 'Short Form 36 (SF-36)', 'timeFrame': 'through study completion, an average of one and a half months', 'description': 'The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL.'}, {'measure': 'Locomotor capacity index', 'timeFrame': 'through study completion, an average of one month', 'description': "The Locomotor Capabilities Index (LCI) is a validated measure of lower-limb amputees' ability to perform activities with prosthesis. The total LCI score is the sum of the item scores and can range from 0 (worst) to 30 (best)."}, {'measure': 'Likert scale', 'timeFrame': 'through study completion, an average of one month', 'description': 'Level of difficulty experienced during walking on straight road, walking uneven road, ascending stairs, descending stairs, ascending ramps and descending ramps will be recorded on a 5-point Likert scale ((1) very easy, (2) easy , (3) neutral, (4) difficult, (5) very difficult).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amputation', 'chopart', 'satisfaction'], 'conditions': ['Traumatic Amputation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.', 'detailedDescription': 'The purpose of this study is to investigate the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.\n\nThis study will be useful for prescribing the appropriate prosthesis in patients with Chopart amputation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 24 patients with unilateral Chopart amputation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-65\n* Having a unilateral traumatic Chopart amputation\n* To have completed prosthesis training\n* Using prosthesis for at least 6 hours a day\n* Being at K3-K4 activity level\n\nExclusion Criteria:\n\n* Bilateral lower extremity amputation\n* Presence of wound on stump\n* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance'}, 'identificationModule': {'nctId': 'NCT05850104', 'briefTitle': 'Comparison of Classical Prosthesis and Silicone Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'Comparison of Classical Prosthesis and Silicone Prosthesis in Patients With Chopart Amputation', 'orgStudyIdInfo': {'id': '38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'classical prosthesis group', 'description': 'the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation', 'interventionNames': ['Other: the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.']}, {'label': 'silicone prosthesis group', 'description': 'the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation', 'interventionNames': ['Other: the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.']}], 'interventions': [{'name': 'the effects of classical Chopart prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.', 'type': 'OTHER', 'description': 'the effects of classical Chopart prosthesis and silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.', 'armGroupLabels': ['classical prosthesis group']}, {'name': 'the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.', 'type': 'OTHER', 'description': 'the effects of silicone prosthesis on socket comfort, satisfaction level and quality of life in patients with unilateral Chopart amputation.', 'armGroupLabels': ['silicone prosthesis group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Merve Örücü Atar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'associate professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yasin Demir', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}