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临床试验/NCT06128135
NCT06128135Enrolling By Invitation不适用

Identify the Prosthesis Users' Necessities Concerning Their Devices.

Federal University of Espirito Santo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Prosthesis users with at least 6 months of device use.
  • •Therapists with experience in working with amputees.
  • •Relatives of the prosthesis users.

排除标准

  • 未提供

结局指标

主要结局

Number of patients that have an unconformity with the weight of the device and which functional characteristics they would improve their devices

时间窗: 1 hour

次要结局

未报告次要终点

研究者

发起方
Federal University of Espirito Santo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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