Disability PhysicalMATCHNCT04723784
AssessMent and Counseling to Get the Best Efficiency and Effectiveness of the Assistive TeCHnology
A study testing Initial Assessment, Implementation of assistive technology in the daily life of participants and Application of outcome measures in people with Disability Physical and Disability, Learning, run by Universidade da Coruña at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 months to 21 years
- Conditions the study is for
- Disability Physical, Disability, Learning, Disabling Disease
- What is being tested?
- Initial Assessment, Implementation of assistive technology in the daily life of participants and Application of outcome measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesSpain
- Study dates
- 15 Jul 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Faculty of Health Sciences. University of A Coruña
A Coruña, Galicia, 15006
Faculty of Health Science
A Coruña, 15006
University of Alcalá de Henares
Alcalá de Henares, Madrid, 28801
University of Sevilla
Seville, 41004
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Disability Physical, Disability, Learning, Disabling Disease
- Being tested
- Initial Assessment, Implementation of assistive technology in the daily life of participants, Application of outcome measures
- Keywords
- Assistive technology, outcome measures, robotics, Artificial Inteligence
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial AssessmentOther
Also called Assessment of participants
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.
Implementation of assistive technology in the daily life of participantsOther
Also called Intervention with AT
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.
Application of outcome measuresOther
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| Person with disability | Experimental | * Initial assessment.
* Implementation of AT in the daily life of participants
* Application of outcome measures and analysis of the data Receives: Other: Initial Assessment; Other: Implementation of assistive technology in the daily life of participants; Other: Application of outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two months after the implementation phase
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
Measured: Six months after the implementation phase
Secondary outcomes (4)
Level of matching between person and technology
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Measured: Two months after the implementation phase
Level of matching between person and technology
Assistive Technology Device Predisposition Assessment (ATD PA) - Device form
Measured: Six months after the implementation phase
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.
Measured: Two months after the implementation phase
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.
Measured: Six months after the implementation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start15 Jul 2020
- Primary completion15 Sep 2022
- Study completion31 May 2023
Why it stopped: The project has finished and the technological developments have been created
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, University of Seville
- Responsible party
- Principal investigator, Thais Pousada, Universidade da Coruña
- Investigators
- Salvador Naya Fernández, PhD, Study chair, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723784
- Sponsor's protocol ID
- 2020/597
- Acronym
- MATCH
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groba B, Pousada T, Nieto L. Assistive technologies, tools and resources for the access and use of information and communication technologies by people with disabilities. Handbook of Research on Personal Autonomy Technologies and Disability Informatics. 2010.
VVAA. Proyecto EASTIN. Red europea de información sobre las tecnologías para la discapacidad y la autonomía. Minusval. 2005;153:17-34.
Laloma M. Ayudas técnicas y discapacidad. Madrid: Comité Español de Representantes de Personas con Discapacidad; 2005.
Vidal García Alonso J, Prat Pastor J, Rodríguez-Porreor Miret C, Sández Lacuesta J, Vera Luna P. Libro Blanco I+D+I al servicio de las Personas con Discapacidad y las Personas Mayores. Vol. 1. Madrid: Ministerio de trabajo y asuntos sociales, Ministerio de Ciencia y tecnología; 2003.
Scherer. Assistive technology matching device and consumer for successful rehabilitation. Washington DC: American psychological Association; 2001.
Scherer M, Jutai J, Fuhrer M, Demers L, Deruyter F. A framework for modelling the selection of assistive technology devices (ATDs). Disabil Rehabil Assist Technol. 2007 Jan;2(1):1-8. doi: 10.1080/17483100600845414.
PubMed 19263548Pousada Garcia T, Groba Gonzalez B, Nieto Rivero L, Pereira Loureiro J, Diez Villoria E, Pazos Sierra A. Exploring the Psychosocial Impact of Wheelchair and Contextual Factors on Quality of Life of People with Neuromuscular Disorders. Assist Technol. 2015 Winter;27(4):246-56. doi: 10.1080/10400435.2015.1045996.
PubMed 26186427DeRuyter. The importance of outcome measures for assistive tehcnology service delivery systems. Technol Disabil. 1997;6:89-104.
World Health Organization. Global priority research agenda for improving access to high-quality affordable assistive technology The Initiative [Internet]. Geneva; 2017 [cited 2017 Jul 18]. Available from: http://apps.who.int/iris/bitstream/10665/254660/1/WHO-EMP-IAU-2017.02-eng.pdf?ua=1
Fuhrer MJ, Jutai JW, Scherer MJ, DeRuyter F. A framework for the conceptual modelling of assistive technology device outcomes. Disabil Rehabil. 2003 Nov 18;25(22):1243-51. doi: 10.1080/09638280310001596207.
PubMed 14617441Smith RO, Rust KL, Jansen C, & Seitz J. ATOMS Project technical report - The ICF in the context of assistive technology (AT) interventions and outcomes [Internet]. Vol. 2010. 2006. Available from: http://www.r2d2.uwm.edu/atoms/archive/icf.html.
Jimenez Arberas E. "Impacto psicosocial de los productos y tecnologías de apoyo para la comunicación en personas con discapacidad auditiva y personas sordas [Internet]. University of Salamanca; 2016. Available from: http://sid.usal.es/idocs/F8/FDO27380/JimenezArberas.pdf
Pousada Garcia T. Impacto psicosocial de la silla de ruedas en la vida de las personas con enfermerades neuromusculares. [A Coruña]: Universidade da Coruña; 2011.
Groba B, Pousada T, Nieto L. Assistive technologies, tools and resources for the access and use of information and communication technologies by people with disabilities. Assistive Technologies: Concepts, Methodologies, Tools, and Applications. 2013.
Pousada T, Groba B, Nieto-Riveiro L, Pazos A, Diez E, Pereira J. Determining the burden of the family caregivers of people with neuromuscular diseases who use a wheelchair. Medicine (Baltimore). 2018 Jun;97(24):e11039. doi: 10.1097/MD.0000000000011039.
PubMed 29901600
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Http://Talionis.Citic.Udc.es
- ClinicalTrials.gov ID
- NCT04723784
- Acronym / sponsor ID
- MATCH / 2020/597
- Conditions
- Disability Physical, Disability, Learning, Disabling Disease
- Keywords
- Assistive technology, outcome measures, robotics, Artificial Inteligence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The project has finished and the technological developments have been created
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- University of Alcala, University of Seville
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person with disability | Experimental | Other: Initial Assessment, Other: Implementation of assistive technology in the daily life of participants, Other: Application of outcome measures* Initial assessment. * Implementation of AT in the daily life of participants * Application of outcome measures and analysis of the data |
Who may qualify
- Ages
- 24 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial AssessmentAlso: Assessment of participantsIn 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 | Person with disability |
| Implementation of assistive technology in the daily life of participantsAlso: Intervention with ATThe 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 | Person with disability |
| Application of outcome measuresAlso: Outcome measuresAfter 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 | Person with disability |
Primary outcome
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
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
4 secondary outcomes
Level of matching between person and technology
Time frame: Two months after the implementation phase
Level of matching between person and technology
Time frame: 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
Level of Independence in the performance for activities of daily living
Time frame: Six months after the implementation phase
Results and safety
The study was stopped early (reason given: The project has finished and the technological developments have been created). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- BackgroundGroba B, Pousada T, Nieto L. Assistive technologies, tools and resources for the access and use of information and communication technologies by people with disabilities. Handbook of Research on Personal Autonomy Technologies and Disability Informatics. 2010.
- BackgroundVVAA. Proyecto EASTIN. Red europea de información sobre las tecnologías para la discapacidad y la autonomía. Minusval. 2005;153:17-34.
- BackgroundLaloma M. Ayudas técnicas y discapacidad. Madrid: Comité Español de Representantes de Personas con Discapacidad; 2005.
- BackgroundVidal García Alonso J, Prat Pastor J, Rodríguez-Porreor Miret C, Sández Lacuesta J, Vera Luna P. Libro Blanco I+D+I al servicio de las Personas con Discapacidad y las Personas Mayores. Vol. 1. Madrid: Ministerio de trabajo y asuntos sociales, Ministerio de Ciencia y tecnología; 2003.
- BackgroundScherer. Assistive technology matching device and consumer for successful rehabilitation. Washington DC: American psychological Association; 2001.
- Background: PubMed 19263548Scherer M, Jutai J, Fuhrer M, Demers L, Deruyter F. A framework for modelling the selection of assistive technology devices (ATDs). Disabil Rehabil Assist Technol. 2007 Jan;2(1):1-8. doi: 10.1080/17483100600845414.
- Background: PubMed 26186427Pousada Garcia T, Groba Gonzalez B, Nieto Rivero L, Pereira Loureiro J, Diez Villoria E, Pazos Sierra A. Exploring the Psychosocial Impact of Wheelchair and Contextual Factors on Quality of Life of People with Neuromuscular Disorders. Assist Technol. 2015 Winter;27(4):246-56. doi: 10.1080/10400435.2015.1045996.
- BackgroundDeRuyter. The importance of outcome measures for assistive tehcnology service delivery systems. Technol Disabil. 1997;6:89-104.
- BackgroundWorld Health Organization. Global priority research agenda for improving access to high-quality affordable assistive technology The Initiative [Internet]. Geneva; 2017 [cited 2017 Jul 18]. Available from: http://apps.who.int/iris/bitstream/10665/254660/1/WHO-EMP-IAU-2017.02-eng.pdf?ua=1
- Background: PubMed 14617441Fuhrer MJ, Jutai JW, Scherer MJ, DeRuyter F. A framework for the conceptual modelling of assistive technology device outcomes. Disabil Rehabil. 2003 Nov 18;25(22):1243-51. doi: 10.1080/09638280310001596207.
- BackgroundSmith RO, Rust KL, Jansen C, & Seitz J. ATOMS Project technical report - The ICF in the context of assistive technology (AT) interventions and outcomes [Internet]. Vol. 2010. 2006. Available from: http://www.r2d2.uwm.edu/atoms/archive/icf.html.
- BackgroundJimenez Arberas E. "Impacto psicosocial de los productos y tecnologías de apoyo para la comunicación en personas con discapacidad auditiva y personas sordas [Internet]. University of Salamanca; 2016. Available from: http://sid.usal.es/idocs/F8/FDO27380/JimenezArberas.pdf
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador Naya Fernández, PhD study chair
Universidade da Coruña
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Assessment, Implementation of assistive technology in the daily life of participants and Application of outcome measures in people with Disability Physical and Disability, Learning, run by Universidade da Coruña at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The project has finished and the technological developments have been created). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Impact of the assistive technology in the life of people with disability (time frame: Two months after the implementation phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723784, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.