Clinical trial NCT04723784: AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology
Official title: Http://Talionis.Citic.Udc.es
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Disability Physical
Disability, Learning
Disabling Disease
Keywords: Assistive technology
outcome measures
robotics
Artificial Inteligence
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: University of Alcala
name: University of Seville
First posted: 2021-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

According to this hypothesis, the research groups has fixed two main objectives for the MATCH subproject:

* To determine the psychosocial impact of AT created during the coordinated project (AIR4ALL) on the life of people with disabilities.
* To promote the best match between the user and the assistive technology used.

To complete, few secondary goals have been proposed:

* To assess the functional skills and abilities of people with disabilities, and to identify their needs to get independence in mobility and activities of daily living.
* To design and create the best technology solutions individualized for each person, meeting with the design for all principles, and promoting the involvement of the final user.
* To validate the assistive technology's solutions designed and prototyped in order to increase the levels of participation in daily activities to people with disabilities.
* To validate a protocol/model of outcome measures in the field of assistive technology to increase the efficiency and effectiveness of selecting and prescribing these products.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Psychosocial Impact of the assistive technology in the life of people with disability
timeFrame: Two months after the implementation phase
measure: Psychosocial Impact of the assistive technology in the life of people with disability
timeFrame: Six months after the implementation phase
Secondary outcomes:
measure: Level of matching between person and technology
timeFrame: Two months after the implementation phase
measure: Level of matching between person and technology
timeFrame: Six months after the implementation phase
measure: Level of Independence in the performance for activities of daily living.
timeFrame: Two months after the implementation phase
measure: Level of Independence in the performance for activities of daily living
timeFrame: Six months after the implementation phase
Other outcomes:
measure: Personal mobility: Capacity to stand up and start the walk
timeFrame: Two months after the implementation phase
measure: Personal mobility: Capacity to stand up and start the walk
timeFrame: two and six months after the implementation phase
measure: Personal mobility and walking during a 10-meter journey
timeFrame: Two months after the implementation phase
measure: Personal mobility and walking during a 10-meter journey.
timeFrame: Two and six months after the implementation phase
measure: Personal mobility and walking during a 6 minutes walking.
timeFrame: Two months after the implementation phase
measure: Personal mobility and walking during a 6 minutes walking.
timeFrame: Two and six months after the implementation phase
Locations:
city: A Coruña
country: Spain
facility: Faculty of Health Sciences. University of A Coruña
state: Galicia
city: Alcalá De Henares
country: Spain
facility: University of Alcalá de Henares
state: Madrid
city: A Coruña
country: Spain
facility: Faculty of Health Science
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: Universidade da Coruña
name: Salvador Naya Fernández, PhD
role: STUDY_CHAIR
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