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

NCT04723784 | Terminated DMC

• 1 other identifier: 2020/597
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Disability Physical; Disability, Learning; Disabling Disease

Keywords

Assistive technology; outcome measures; robotics; Artificial Inteligence

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Six months after the implementation phase

Secondary Outcomes (4)

• Level of matching between person and technology

  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.

  Two months after the implementation phase

• Level of Independence in the performance for activities of daily living

  Six months after the implementation phase

Other Outcomes (6)

• Personal mobility: Capacity to stand up and start the walk

  Two months after the implementation phase

• Personal mobility: Capacity to stand up and start the walk

  two and six months after the implementation phase

• Personal mobility and walking during a 10-meter journey

  Two months after the implementation phase

Study Arms (1)

Person with disability

EXPERIMENTAL

* Initial assessment. * Implementation of AT in the daily life of participants * Application of outcome measures and analysis of the data

Other: Initial Assessment; Other: Implementation of assistive technology in the daily life of participants; Other: Application of outcome measures

Interventions

Initial Assessment OTHER

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.

Also known as: Assessment of participants

Person with disability

Implementation of assistive technology in the daily life of participants OTHER

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.

Also known as: Intervention with AT

Person with disability

Application of outcome measures OTHER

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).

Also known as: Outcome measures

Person with disability

Eligibility Criteria

• Age: 24 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• University of Alcala: collaborator
• University of Seville: collaborator

Study Sites (4)

Faculty of Health Sciences. University of A Coruña

A Coruña, Galicia, 15006, Spain

Location

University of Alcalá de Henares

Alcalá de Henares, Madrid, 28801, Spain

Location

Faculty of Health Science

A Coruña, 15006, Spain

Location

University of Sevilla

Seville, 41004, Spain

Location

Related Publications (23)

• 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.

  BACKGROUND

• VVAA. Proyecto EASTIN. Red europea de información sobre las tecnologías para la discapacidad y la autonomía. Minusval. 2005;153:17-34.

  BACKGROUND

• Laloma M. Ayudas técnicas y discapacidad. Madrid: Comité Español de Representantes de Personas con Discapacidad; 2005.

  BACKGROUND

• 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.

  BACKGROUND

• Scherer. Assistive technology matching device and consumer for successful rehabilitation. Washington DC: American psychological Association; 2001.

  BACKGROUND

• 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.

  PMID: 19263548 BACKGROUND

• Pousada 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.

  PMID: 26186427 BACKGROUND

• DeRuyter. The importance of outcome measures for assistive tehcnology service delivery systems. Technol Disabil. 1997;6:89-104.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 14617441 BACKGROUND

• Smith 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29901600 BACKGROUND

• Pousada T, Pereira-Loureiro J, Díez E, Groba B, Nieto-Riveiro L, Pazos A. Needs, demands and reality of people with neuromuscular disorders users of wheelchair. Examines Phys Med Rehabil [Internet]. 2017 Nov 13 [cited 2019 Jul 15];1(1). Available from: https://ruc.udc.es/dspace/handle/2183/20294

  BACKGROUND

• Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

  PMID: 12890299 BACKGROUND

• Mylius CF, Paap D, Takken T. Reference value for the 6-minute walk test in children and adolescents: a systematic review. Expert Rev Respir Med. 2016 Dec;10(12):1335-1352. doi: 10.1080/17476348.2016.1258305. Epub 2016 Nov 21.

  PMID: 27817221 BACKGROUND

• Peters DM, Fritz SL, Krotish DE. Assessing the reliability and validity of a shorter walk test compared with the 10-Meter Walk Test for measurements of gait speed in healthy, older adults. J Geriatr Phys Ther. 2013 Jan-Mar;36(1):24-30. doi: 10.1519/JPT.0b013e318248e20d.

  PMID: 22415358 BACKGROUND

• Garcia C. Adaptación transcultural y validación de la versión en español de la Pediatric Balance Scale. Universidad de Extremadura; 2017.

  BACKGROUND

• Uniform Data System for Medical. Functional Independence Measure, version 5.1. New York: Buffalo General Hospital; 1997.

  BACKGROUND

• Martinez-Martin P, Fernandez-Mayoralas G, Frades-Payo B, Rojo-Perez F, Petidier R, Rodriguez-Rodriguez V, Forjaz MJ, Prieto-Flores ME, de Pedro Cuesta J. [Validation of the functional independence scale]. Gac Sanit. 2009 Jan-Feb;23(1):49-54. doi: 10.1016/j.gaceta.2008.06.007. Epub 2009 Jan 9. Spanish.

  PMID: 19231723 BACKGROUND

• Pousada Garcia T, Groba Gonzalez B, Nieto-Riveiro L, Canosa Dominguez N, Maldonado-Bascon S, Lopez-Sastre RJ, Pacheco DaCosta S, Gonzalez-Gomez I, Molina-Cantero AJ, Pereira Loureiro J. Assessment and counseling to get the best efficiency and effectiveness of the assistive technology (MATCH): Study protocol. PLoS One. 2022 Mar 16;17(3):e0265466. doi: 10.1371/journal.pone.0265466. eCollection 2022.

  PMID: 35294488 DERIVED

MeSH Terms

Conditions

Learning Disabilities

Interventions

Methods; Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Salvador Naya Fernández, PhD

  Universidade da Coruña

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 26, 2021
• Study Start: July 15, 2020
• Primary Completion: September 15, 2022
• Study Completion: May 31, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)