Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT06128135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-30
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identify the Prosthesis Users' Necessities Concerning Their Devices.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-08', 'size': 189355, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-09T11:39', 'hasProtocol': True}, {'date': '2023-11-06', 'size': 157988, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-07T14:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices', 'timeFrame': '1 hour'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Upper Limb Amputation at the Hand']}, 'descriptionModule': {'briefSummary': 'Despite many advances in prosthesis development, there are still some areas that need to be improved. One of them is the weight of the devices which could cause muscular fatigue in long-term use of the prosthesis and even abandonment. This study aims to identify the desired improvements in prosthetic devices from the perspective of the users, therapists, and relatives. That would be done through two kinds of questionnaires about technology acceptance.', 'detailedDescription': 'The World Health Organization (WHO) estimates that around 1.3 billion people experience significant disability. One of the actual challenges is facilitating and breaking the barriers of persons with disabilities. Assistance technology supports inclusion and participation, principally for people with disabilities.\n\nIn Brazil, the DATASUS estimated that around 57802 amputations (one kind of disability) were performed in 2022. Prostheses are assistive devices that aim to mitigate the psychological impact of missing a member and help in activities of daily life (ADL). One kind of prosthesis is electrically powered, which uses electrical components to actuate the device and is commonly controlled by body signals such as surface electromyography (sEMG). Despite many advances in prosthesis development, some areas need to be improved such as weight, size, ergonomic design, etc. of the devices which could cause muscular fatigue in long-term use of the prosthesis and even abandonment.\n\nThis study aims to identify the aspects that cause major discomfort in upper limb prosthesis users. Also, recognize in which activities of daily life, the prosthesis is involved. That information will be used to improve the design of an upper limb prosthesis.\n\nFor the execution, two kinds of questionnaires about technology acceptance will be used. In the first questionnaire, which is for prosthesis users, there will be 15 questions to identify in what kind of activities the person uses the prosthesis, how much is the use time and what is the main problem with the device. In the second questionnaire, which is for the therapist and relatives, there will be 9 questions to analyze which device characteristics cause major discomfort during the use and could be improved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inhabitants of Brazil, from the state of Espírito Santo. The participants are associated with the Crefes rehabilitation center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prosthesis users with at least 6 months of device use.\n* Therapists with experience in working with amputees.\n* Relatives of the prosthesis users.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06128135', 'briefTitle': "Identify the Prosthesis Users' Necessities Concerning Their Devices.", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Espirito Santo'}, 'officialTitle': "Identify the Prosthesis Users' Necessities Concerning Their Devices.", 'orgStudyIdInfo': {'id': '202310261600'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prosthesis Users', 'description': '30 participants, aged between 18 and 60, will be part of the study. The users must have at least 6 months of experience using upper limb prostheses. They will be asked a 15-question survey about their upper limb prostheses.', 'interventionNames': ['Other: Technology acceptance questionnaire for prostheses users.']}, {'label': 'Therapists', 'description': '10 therapists that have experience working with prostheses. They will be asked a 9-question survey about upper limb prostheses that they usually handle.', 'interventionNames': ['Other: Technology acceptance questionnaire for therapists']}, {'label': 'Relatives', 'description': "30 of the prosthesis users' relatives who live with the person and see the daily difficulties of using the device. They will be asked a 9-question survey about the device that their relatives costume to use.", 'interventionNames': ['Other: Technology acceptance questionnaire for relatives of prostheses users.']}], 'interventions': [{'name': 'Technology acceptance questionnaire for prostheses users.', 'type': 'OTHER', 'description': 'One questionnaire, which is for prosthesis users, where will be 15 questions to identify what kind of activities the person uses the prosthesis, how much is the use time and what is the main problem with the device.', 'armGroupLabels': ['Prosthesis Users']}, {'name': 'Technology acceptance questionnaire for relatives of prostheses users.', 'type': 'OTHER', 'description': 'One questionnaire, where there will be between 8 questions to analyze which device characteristics, they think cause major discomfort during the use and could be improved.', 'armGroupLabels': ['Relatives']}, {'name': 'Technology acceptance questionnaire for therapists', 'type': 'OTHER', 'description': 'One questionnaire, where there will be between 9 questions to analyze which device characteristics, they think cause major discomfort during the use and could be improved.', 'armGroupLabels': ['Therapists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29101030', 'city': 'Vila Velha', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Centro de Reabilitação Física do Espírito Santo', 'geoPoint': {'lat': -20.32972, 'lon': -40.2925}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Espirito Santo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}