AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology (MATCH)

November 27, 2023 updated by: Thais Pousada, Universidade da Coruña

Http://Talionis.Citic.Udc.es

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Faculty of Health Science
      • Sevilla, Spain, 41004
        • University of Sevilla
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Faculty of Health Sciences. University of A Coruña
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28801
        • University of Alcalá de Henares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Person with disability
  • Initial assessment.
  • Implementation of AT in the daily life of participants
  • Application of outcome measures and analysis of the data
Other: Initial Assessment
In this phase the evaluation of the participants will be done, with the application of the instrument presented in outcome measures' section. According to the age of the person, specific questionnaires will be used to gather information more concrete about the skills for mobility. This assessment will allow determining the specific needs, demands and capabilities of participants. The assessment process will be done by professionals of research groups in rooms of collaborators centers.
Other Names:
  • Assessment of participants
Other: Implementation of assistive technology in the daily life of participants
The professionals of collaborator centers, supported by the research groups, will carry on the training in the use of AT by the participants, facilitating its incorporation during the performance of activities of daily living.
Other Names:
  • Intervention with AT
Other: Application of outcome measures
After the process of implementation of AT (the next 2 and 6 months), members of the research group and the professionals of collaborators centers will apply the measurement instruments to determine the possible improvements in the level of functional independence (FIM scale) of people with disabilities, the impact that the AT has had on their lifes (PIADS scale) and the level of matching between person and AT (ATD PA - MPT model).
Other Names:
  • Outcome measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial Impact of the assistive technology in the life of people with disability
Time Frame: Two 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
Two months after the implementation phase
Psychosocial Impact of the assistive technology in the life of people with disability
Time Frame: 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
Six months after the implementation phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of matching between person and technology
Time Frame: Two months after the implementation phase
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Two months after the implementation phase
Level of matching between person and technology
Time Frame: Six months after the implementation phase
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Six months after the implementation phase
Level of Independence in the performance for activities of daily living.
Time Frame: Two months after the implementation phase
Functional Independence Measure (FIM). The lowest score of the scale is 18, the highest score is 126.
Two months after the implementation phase
Level of Independence in the performance for activities of daily living
Time Frame: Six months after the implementation phase
Functional Independence Measure (FIM): The lowest score of the scale is 18, the highest score is 126.
Six months after the implementation phase

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal mobility: Capacity to stand up and start the walk
Time Frame: Two months after the implementation phase
Test up & go
Two months after the implementation phase
Personal mobility: Capacity to stand up and start the walk
Time Frame: two and six months after the implementation phase
Test up & go
two and six months after the implementation phase
Personal mobility and walking during a 10-meter journey
Time Frame: Two months after the implementation phase
10 meter walk test: The outcome of this measure is the time it takes the person to walk 10 meters
Two months after the implementation phase
Personal mobility and walking during a 10-meter journey.
Time Frame: Two and six months after the implementation phase
10 meter walk test. The outcome of this measure is the time it takes the person to walk 10 meters
Two and six months after the implementation phase
Personal mobility and walking during a 6 minutes walking.
Time Frame: Two months after the implementation phase
6 minute walk Test; The outocme of this test is the distance traveled during 6 minutes.
Two months after the implementation phase
Personal mobility and walking during a 6 minutes walking.
Time Frame: Two and six months after the implementation phase
6 minute walk Test; The outocme of this test is the distance traveled during 6 minutes.
Two and six months after the implementation phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Collaborators

University of Alcala
University of Seville

Investigators

  • Study Chair: Salvador Naya Fernández, PhD, Universidade da Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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