AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology (MATCH)
Primary Purpose
Disability Physical, Disability, Learning, Disabling Disease
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Initial Assessment
Implementation of assistive technology in the daily life of participants
Application of outcome measures
Sponsored by
About this trial
This is an interventional health services research trial for Disability Physical focused on measuring Assistive technology, outcome measures, robotics, Artificial Inteligence
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.
Sites / Locations
- Faculty of Health Sciences. University of A Coruña
- University of Alcalá de Henares
- Faculty of Health Science
- University of Sevilla
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Person with disability
Arm Description
Initial assessment. Implementation of AT in the daily life of participants Application of outcome measures and analysis of the data
Outcomes
Primary Outcome Measures
Psychosocial Impact of the assistive technology in the life of people with disability
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
Psychosocial Impact of the assistive technology in the life of people with disability
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
Secondary Outcome Measures
Level of matching between person and technology
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Level of matching between person and technology
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Level of Independence in the performance for activities of daily living.
Functional Independence Measure (FIM). The lowest score of the scale is 18, the highest score is 126.
Level of Independence in the performance for activities of daily living
Functional Independence Measure (FIM): The lowest score of the scale is 18, the highest score is 126.
Full Information
NCT ID
NCT04723784
First Posted
January 12, 2021
Last Updated
October 31, 2022
Sponsor
Universidade da Coruña
Collaborators
University of Alcala, University of Seville
1. Study Identification
Unique Protocol Identification Number
NCT04723784
Brief Title
AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology
Acronym
MATCH
Official Title
Http://Talionis.Citic.Udc.es
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña
Collaborators
University of Alcala, University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical, Disability, Learning, Disabling Disease
Keywords
Assistive technology, outcome measures, robotics, Artificial Inteligence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Person with disability
Arm Type
Experimental
Arm Description
Initial assessment.
Implementation of AT in the daily life of participants
Application of outcome measures and analysis of the data
Intervention Type
Other
Intervention Name(s)
Initial Assessment
Other Intervention Name(s)
Assessment of participants
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Implementation of assistive technology in the daily life of participants
Other Intervention Name(s)
Intervention with AT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Application of outcome measures
Other Intervention Name(s)
Outcome measures
Intervention Description
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).
Primary Outcome Measure Information:
Title
Psychosocial Impact of the assistive technology in the life of people with disability
Description
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
Time Frame
Two months after the implementation phase
Title
Psychosocial Impact of the assistive technology in the life of people with disability
Description
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
Time Frame
Six months after the implementation phase
Secondary Outcome Measure Information:
Title
Level of matching between person and technology
Description
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Time Frame
Two months after the implementation phase
Title
Level of matching between person and technology
Description
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Time Frame
Six months after the implementation phase
Title
Level of Independence in the performance for activities of daily living.
Description
Functional Independence Measure (FIM). The lowest score of the scale is 18, the highest score is 126.
Time Frame
Two months after the implementation phase
Title
Level of Independence in the performance for activities of daily living
Description
Functional Independence Measure (FIM): The lowest score of the scale is 18, the highest score is 126.
Time Frame
Six months after the implementation phase
Other Pre-specified Outcome Measures:
Title
Personal mobility: Capacity to stand up and start the walk
Description
Test up & go
Time Frame
Two months after the implementation phase
Title
Personal mobility: Capacity to stand up and start the walk
Description
Test up & go
Time Frame
two and six months after the implementation phase
Title
Personal mobility and walking during a 10-meter journey
Description
10 meter walk test: The outcome of this measure is the time it takes the person to walk 10 meters
Time Frame
Two months after the implementation phase
Title
Personal mobility and walking during a 10-meter journey.
Description
10 meter walk test. The outcome of this measure is the time it takes the person to walk 10 meters
Time Frame
Two and six months after the implementation phase
Title
Personal mobility and walking during a 6 minutes walking.
Description
6 minute walk Test; The outocme of this test is the distance traveled during 6 minutes.
Time Frame
Two months after the implementation phase
Title
Personal mobility and walking during a 6 minutes walking.
Description
6 minute walk Test; The outocme of this test is the distance traveled during 6 minutes.
Time Frame
Two and six months after the implementation phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Naya Fernández, PhD
Organizational Affiliation
Universidade da Coruña
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Health Sciences. University of A Coruña
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
University of Alcalá de Henares
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain
Facility Name
Faculty of Health Science
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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