Implicación de usuarios en proyectos de investigación tecnológica (ImUPITec): análisis de procedimientos éticos, metodologías y herramientas y propuesta de mejora orientada a personas mayores

160 p.Hoy en día es habitual implicar a los usuarios finales en los proyectos tecnológicos de investigación con la finalidad de mejorar la usabilidad, aceptación y utilidad de los sistemas o dispositivos a desarrollar. Existen numerosas técnicas y metodologías para la participación e implicación de usuarios y stakeholders, pero la selección de las más adecuadas no siempre es sencilla. Es muy importante identificar estas herramientas para trabajar con los usuarios objetivo, así como las dificultades que nos podemos encontrar con cada una de ellas.En este proyecto de tesis se parte de la hipótesis de que algunas herramientas no son adecuadas para ser utilizadas con personas mayores sin antes haber realizado ciertas adaptaciones. Por ello, en este trabajo se presenta un análisis de las diferentes metodologías de implicación de usuarios o stakeholders para la mejora del diseño y la usabilidad de desarrollos tecnológicos, así como una nueva metodología y clasificación de las herramientas asociadas a dicha metodología. A partir de esta propuesta se ha analizado el uso de algunas de las herramientas con la población mayor para realizar una serie de propuestas de mejora cuando se utilizan con dichas personas. Asimismo, se ha generado un repositorio web donde consultar las características de las herramientas.Adicionalmente, en este proyecto se discuten los aspectos éticos y legales que se deben tener en cuenta a la hora de implicar seres humanos en una investigación, y por tanto las dificultades que se encuentran los investigadores, específicamente en la rama tecnológica, a la hora de interpretar la documentación relacionada con esta temática. Para ello, se ha analizado la documentación acerca de los aspectos éticos y legales que aplican y se han desarrollado diferentes mecanismos que ayuden a los investigadores a interpretar las directivas, regulaciones, recomendaciones, buenas prácticas y legislación aplicable en cada caso. Por un lado, se han desarrollado una serie de plantillas para facilitar la tarea de completar el diseño metodológico que implica a seres humanos en la investigación, incluyendo el proceso de consentimiento informado. Por otro lado, se ha propuesto un diagrama de flujo de ayuda a la toma de decisiones a realizar. Por último, se ha creado una herramienta que da soporte a dicho diagrama. La herramienta desarrollada ha sido evaluada para mejorar su usabilidad y estos materiales se han puesto a disposición de los investigadores para que puedan ser utilizados en el día a día con proyectos reales.El trabajo realizado plantea una serie de líneas futuras de investigación que también se esbozan en esta memoria

Implicación de usuarios en proyectos de investigación tecnológica (ImUPITec): análisis de procedimientos éticos, metodologías y herramientas y propuesta de mejora orientada a personas mayores

160 p.Hoy en día es habitual implicar a los usuarios finales en los proyectos tecnológicos de investigación con la finalidad de mejorar la usabilidad, aceptación y utilidad de los sistemas o dispositivos a desarrollar. Existen numerosas técnicas y metodologías para la participación e implicación de usuarios y stakeholders, pero la selección de las más adecuadas no siempre es sencilla. Es muy importante identificar estas herramientas para trabajar con los usuarios objetivo, así como las dificultades que nos podemos encontrar con cada una de ellas.En este proyecto de tesis se parte de la hipótesis de que algunas herramientas no son adecuadas para ser utilizadas con personas mayores sin antes haber realizado ciertas adaptaciones. Por ello, en este trabajo se presenta un análisis de las diferentes metodologías de implicación de usuarios o stakeholders para la mejora del diseño y la usabilidad de desarrollos tecnológicos, así como una nueva metodología y clasificación de las herramientas asociadas a dicha metodología. A partir de esta propuesta se ha analizado el uso de algunas de las herramientas con la población mayor para realizar una serie de propuestas de mejora cuando se utilizan con dichas personas. Asimismo, se ha generado un repositorio web donde consultar las características de las herramientas.Adicionalmente, en este proyecto se discuten los aspectos éticos y legales que se deben tener en cuenta a la hora de implicar seres humanos en una investigación, y por tanto las dificultades que se encuentran los investigadores, específicamente en la rama tecnológica, a la hora de interpretar la documentación relacionada con esta temática. Para ello, se ha analizado la documentación acerca de los aspectos éticos y legales que aplican y se han desarrollado diferentes mecanismos que ayuden a los investigadores a interpretar las directivas, regulaciones, recomendaciones, buenas prácticas y legislación aplicable en cada caso. Por un lado, se han desarrollado una serie de plantillas para facilitar la tarea de completar el diseño metodológico que implica a seres humanos en la investigación, incluyendo el proceso de consentimiento informado. Por otro lado, se ha propuesto un diagrama de flujo de ayuda a la toma de decisiones a realizar. Por último, se ha creado una herramienta que da soporte a dicho diagrama. La herramienta desarrollada ha sido evaluada para mejorar su usabilidad y estos materiales se han puesto a disposición de los investigadores para que puedan ser utilizados en el día a día con proyectos reales.El trabajo realizado plantea una serie de líneas futuras de investigación que también se esbozan en esta memoria

Modelling the Component-based Architecture and Safety Contracts of ArmAssist in Papyrus for Robotics

Healthcare robots are increasingly being used and the way they are engineered they still have several challenges regarding reference models and validation. In this experience report we focus on the ArmAssist robotic system and how it can be modelled including safety considerations for validation in early design phases. ArmAssist is an upper-limb robotic system for stroke rehabilitation based on serious games. The open-source tool Papyrus for Robotics was used for modelling the robotic system in close collaboration with neurorehabilitation domain experts. Papyrus for Robotics includes new functionalities that we contributed for contract-based design at component and system level, allowing to make explicit and validate the safety considerations using formal languages. In our case, the assertions are expressed in OCL and Othello. We present the resulting model and a discussion from domain experts.This work has been funded by the SafeCC4Robot Integrated Technical Project which received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No. 732410, in the form of financial support to third parties of the RobMoSys Project. We would like to thank Angel Lopez, Elixabete Ostolaza, Matteo Morelli, ´ and Huascar Espinoza for their help during the tool design and development. The authors also would like to thank to Inigo Dorronsoro, Javier Arcas Ruiz-Ruano, Gabriel Gaminde, ˜ Benat Garcia-Mendizabal, Je Hyung Jung, Cristina Rodriguez- ˜ de-Pablo, Joel Perry, Aitor Belloso, David Valencia and Haritz Zabaleta for their contributions to the ArmAssist system development

HoMEcare aRm rehabiLItatioN (MERLIN): telerehabilitation using an unactuated device based on serious games improves the upper limb function in chronic stroke

HoMEcare aRm rehabiLItatioN (MERLIN) is an unactuated version of the robotic device ArmAssist combined with a telecare platform. Stroke patients are able to train the upper limb function using serious games at home. The aim of this study is to investigate the effect of MERLIN training on the upper limb function of patients with unilateral upper limb paresis in the chronic phase of stroke (> 6 months post stroke). Patients trained task specific serious games for three hours per week during six weeks using an unactuated version of a robotic device. Progress was monitored and game settings were tailored through telerehabilitation. Measurements were performed six weeks pre-intervention (T0), at the start (T1), end (T2) and six weeks post-intervention (T3). Primary outcome was the Wolf Motor Function Test (WMFT). Secondary outcomes were other arm function tests, quality of life, user satisfaction and motivation.This research is part of MERLIN project (19094 and 20649) that has received funding from EIT Health. EIT Health is supported by the European Institute of Innovation and Technology (EIT), a body of the European Union receives support from the European Union´s Horizon 2020 Research and innovation program

Design and development of a gait training system for Parkinson’s disease

Background. Rhythmic Auditory Stimulation (RAS) is an effective technique to improve gait and reduce freezing episodes for Persons with Parkinson’s Disease (PwPD). The BeatHealth system, which comprises a mobile application, gait sensors, and a website, exploits the potential of the RAS technique. This paper describes the tools used for co-designing and evaluating the system and discusses the results and conclusions. Methods. Personas, interviews, use cases, and ethnographic observations were used to define the functional requirements of the system. Low fidelity prototypes were created for iterative and incremental evaluation with end-users. Field trials were also performed with the final system. The process followed a user centered design methodology defined for this project with the aim of building a useful, usable, and easy-to-use system. Results. Functional requirements of the system were produced as a result of the initial exploration phase. Building upon these, mock-ups for the BeatHealth system were created. The mobile application was iterated twice, with the second version of it achieving a rating of 75 when assessed by participants through the System Usability Scale (SUS). After another iteration field trials were performed and the mobile application was rated with an average 78.6 using SUS. Participants rated two website mock-ups, one for health professionals and another for end-users, as good except from minor issues related to visual design (e.g. font size), which were resolved in the final version. Conclusion. The high ratings obtained in the evaluation of the BeatHealth system demonstrate the benefit of applying a user centered design methodology which involves stakeholders from the very beginning. Other important lessons were learned through the process of design and development of the system, such as the importance of motivational aspects, the techniques which work best, and the extra care that has to be taken when evaluating non-functional mock-ups with end users.This work was supported by the BeatHealth project within the 7th Framework Programme of the European Union – Personalised health, active ageing, and independent living, contract Number FP7-610633. See also: http://www.euromov.eu/beathealth/homepage. This work has been also partially supported by the Ministry of Economy and Competitiveness of the Spanish Government and by the European Regional Development Fund (projects TIN2014-52665-C2-1-R and TIN2017-85409-P), and by the Department of Education, Universities and Research of the Basque Government under grant IT980-16

A usability study in patients with stroke using MERLIN, a robotic system based on serious games for upper limb rehabilitation in the home setting

Neuroscience and neurotechnology are transforming stroke rehabilitation. Robotic devices, in addition to telerehabilitation, are increasingly being used to train the upper limbs after stroke, and their use at home allows us to extend institutional rehabilitation by increasing and prolonging therapy. The aim of this study is to assess the usability of the MERLIN robotic system based on serious games for upper limb rehabilitation in people with stroke in the home environment.This research is part of a MERLIN project, which has received funding from EIT Health (Grant no. 20649). EIT Health is supported by the European Institute of Innovation and Technology (EIT), a body of the European Union which receives support from the European Union’s Horizon 2020 Research and innovation programme

BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson’s Disease

Taking regular walks when living with Parkinson’s disease (PD) has beneficial effects on movement and quality of life. Yet, patients usually show reduced physical activity compared to healthy older adults. Using auditory stimulation such as music can facilitate walking but patients vary significantly in their response. An individualized approach adapting musical tempo to patients’ gait cadence, and capitalizing on these individual differences, is likely to provide a rewarding experience, increasing motivation for walk-in PD. We aim to evaluate the observance, safety, tolerance, usability, and enjoyment of a new smartphone application. It was coupled with wearable sensors (BeatWalk) and delivered individualized musical stimulation for gait auto-rehabilitation at home. Forty-five patients with PD underwent a 1-month, outdoor, uncontrolled gait rehabilitation program, using the BeatWalk application (30 min/day, 5 days/week). The music tempo was being aligned in real-time to patients’ gait cadence in a way that could foster an increase up to +10% of their spontaneous cadence. Open-label evaluation was based on BeatWalk use measures, questionnaires, and a six-minute walk test. Patients used the application 78.8% (±28.2) of the prescribed duration and enjoyed it throughout the program. The application was considered “easy to use” by 75% of the patients. Pain, fatigue, and falls did not increase. Fear of falling decreased and quality of life improved. After the program, patients improved their gait parameters in the six-minute walk test without musical stimulation. BeatWalk is an easy to use, safe, and enjoyable musical application for individualized gait rehabilitation in PD. It increases “walk for exercise” duration thanks to high observance.This research was supported by a European grant: BeatHealth: Health and Wellness on the Beat for VC, DD, CL, AGi, VD, RV, EH, ED, ML, BB, and SB (EU FP7-ICT contract #610633)

Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research

In recent years engineers developing new technologies with assistive or medical purposes have become aware that to create acceptable and usable solutions they need to involve final users, patients and stakeholders in the design, development and evaluation of systems as well as in the device certification processes. Involving stakeholders in such processes has several ethical and legal implications. It has become evident that it is still difficult for engineers in Europe to know which ethical and legal processes should be carried out as they have not been previously trained in these issues during their studies. This article is a review of the laws, standards and recommendations applicable in Europe concerning human involvement in new technologies research, with the aim of helping researchers in the region in question to identify the ethical and legal issues that could arise during those tasks. This review has been carried out in response to the identified need on the part of technological researchers. The design of a flowchart is presented as a summary of the interpretation of the documentation reviewed with the aim of helping the researchers to take the ethical and legal decisions that apply to research involving humans. The flowchart presented has been validated with various research projects in which the authors have participated. The proposed conceptual design can be used for taking decisions, but it is suggested that a tool based on this design be built with the aim of making decision taking easier for researchers in this area

MERLIN: Upper-Limb Rehabilitation Robot System for Home Environment

ArmAssist is a cost-effective robotic system for post-stroke upper-limb rehabilitation. The system incorporates the ArmAssist Assessment platform based on serious games that enables fast, quantitative and automatic evaluation of the arm functions. The aim of the MERLIN European project is to bring this system to the patients’ homes to personalize the therapy with reduced supervision while increasing the number of movement repetitions to improve the effectiveness. To this end, the ArmAssist system developed by TECNALIA, has been integrated with GMV’s Antari Home Care platform, to customize and supervise the training remotely. Additionally, several technical improvements have been done to enhance the usability and functionality of the system according to the patients and therapists’ feedback. In this paper, the technical progress of the MERLIN system is presented.EIT Health. 20649. MERLI