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临床试验/NCT04723784
NCT04723784终止不适用

Http://Talionis.Citic.Udc.es

Universidade da Coruña8 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
8
主要终点
Psychosocial Impact of the assistive technology in the life of people with disability

研究概览

简要总结

The best match between any person with disability and the assistive technology (AT) only can be gotten through a complete assessment and a monitoring of the needs, abilities, priorities, difficult and limitations that he/she finds in his/her life. Without this analysis, may be the risk that the AT doesn't adapt to the expectation of the person. Like this, the user, in few time, could abandon the AT device, with the unnecessary spends of resources. Therefore, is important that any project focused in the development of new innovating AT for people with disabilities includes the perspective of outcome measures as an important phase of the research. In this sense, the incorporation of the assessment, implementation process and outcome measures is vital to get the transferability during the whole project and to get the general perspective from the final user.

The protocol presents a project that aims to improve the independence, participation and functional mobility of people with disabilities.

The sample is formed by people with disabilities that will participate from the first stage of the process, with an initial assessment of their abilities and needs, a complete implication during the test of technology, and in the final application of outcome measures instruments.

Only with this perspective and active participation of the users is possible to carry on a user-centered approach. That fact will allow to define and to generate technological solutions that really adjust to the expectations, needs and priorities of the people with disabilities, avoiding that the AT be abandoned, with the consequent health and social spending.

详细描述

The present document is the description of a Subproject of a global and complete coordinated Project, in which are participants the University of A Coruña, the University of Alcalá de Henares and the University of Sevilla, and its title is "Artificial Intelligence and Robotic Assistive Technology devices for Disabled People" (AIR4DP).

The main result of the AIR4DP project consists of the implementation of assistive technology that allows to incorporate the latest advances in Artificial Intelligence to improve life quality of people with disabilities. With this target, the investigators present a coordinated project that is divided into three sub-projects, whose main goals consist of developing and evaluating the breakthrough of the proposed technology in people with functional diversity.

In this Study Protocol, the justification and the development of subproject MATCH are explained. It will be coordinated by the University of A Coruña, and its performance implies the participation of people with disabilities.

Therefore, this project is focused on the implementation of outcome measurement tools to improve the efficacy, effectiveness and real utility of the assistive technology devices (ATD) developed. On the other hand, it is also very important to assess the functional impact the ATD has on the user's participation in their social environment. For that, other measurement tools to assess functional mobility outcomes will also be also carried out during basal assessment and after 6 months of ATD implementation.

For this study protocol, the hypothesis is related to the relevance of the assessment of the interaction between the users and the AT: in order to guarantee a high match person-AT, to also get a positive psychosocial impact in the life of people with disabilities, the assessment and monitoring result two fundamental aspects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
24 Months 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • People with recognized disability, derived by a disease or a permanent health status.
  • Age between 2 and 21 years old.
  • To form part of any of the collaborators' centers with the three universities.
  • To have an independent functional level moderate - low (assessed by the Functional Independence Measure.
  • To have functional skills - mobility domain level moderate - low (assessed by the Spanish version of Pediatric of Disability Inventory - PEDI)

排除标准

  • To have any health status that is incompatible with the use of assistive technology designed and prototyped in the project.
  • To have cognitive skills very limited, that limits to follow the instructions to good use of AT.
  • Not to have adequate human supports to make use of AT.
  • To have functional skills - mobility domain level low (assessed by the Spanish version of Pediatric of Disability Inventory - PEDI), with the need for maximum assistance from caregivers.

结局指标

主要结局

Psychosocial Impact of the assistive technology in the life of people with disability

时间窗: Six months after the implementation phase

Psychosocial impact of assistive technology scale (PIADS): This scale has three dimensions: competence, adaptability and Self-steem. Each of these dimensions can have a minimum value of -3 up to a maximum value of +3. Higher scores mean a better outcome

次要结局

  • Level of Independence in the performance for activities of daily living.(Two months after the implementation phase)
  • Level of matching between person and technology(Six months after the implementation phase)
  • Level of Independence in the performance for activities of daily living(Six months after the implementation phase)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thais Pousada

PhD Professor

Universidade da Coruña

研究点 (8)

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