NCT06128135

Identify the Prosthesis Users' Necessities Concerning Their Devices.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Federal University of Espirito Santo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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. In 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. This 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. For 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.

Conditions

• Upper Limb Amputation at the Hand

Interventions

Type	Name	Description
OTHER	Technology acceptance questionnaire for prostheses users.	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.
OTHER	Technology acceptance questionnaire for relatives of prostheses users.	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.
OTHER	Technology acceptance questionnaire for therapists	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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-11-13
• Last updated: 2024-01-30

Locations

1 site across 1 country: Brazil