Technology applied in neurorehabilitation: a comparative study between the use of conventional therapies and therapies assisted with new technologies in patients affected by a cerebrovascular accident

Introducción: Los avances en neurociencia y neurotecnología están transformando la rehabilitación del ictus. Las terapias asistidas por tecnologías avanzadas están adquiriendo cada vez mayor importancia debido a su capacidad para incorporar los elementos clave para una rehabilitación efectiva según la evidencia científica: intensidad, repetición, intervención temprana y la aplicación de terapias desafiantes, motivadoras y centradas en la función. En este contexto, dispositivos como MERLIN (sistema robótico basado en juegos serios) y FESIA GRASP (dispositivo basado en electroestimulación eléctrica funcional) pueden suponer un gran avance en la neurorrehabilitación del miembro superior con deterioro en la función motora. En la investigación y aplicación de tecnologías avanzadas dentro del ámbito biosanitario, se hacen imprescindibles la evaluación de dos factores: la usabilidad y la efectividad. Los estudios de usabilidad son fundamentales para el éxito de la implementación, ya que determinan en gran medida la utilidad, viabilidad y aceptación de una tecnología o producto. La efectividad proporciona una evaluación sólida del impacto de estas tecnologías avanzadas en los resultados clínicos de salud, fundamental para comprender su verdadero valor y beneficio en la práctica médica. Objetivos: Proyecto Merlín: Evaluar la usabilidad del dispositivo Merlín, así como demostar la viabilidad de incluir esta tecnología como complemento a un programa regular de telerehabilitación. Valorar la motivación y adhesión al tratamiento. Proyecto Fesia Grasp: Evaluar la efectividad en términos de recuperación motora del miembro superior, comparando resultados clínicos tras la aplicación de terapias convencionales frente a terapias asistidas por tecnologías avanzadas. Material y métodos: Proyecto Merlín: ensayo clínico con producto biosanitario, unicéntrico, abierto, longitudinal y no controlado. Nueve participantes en tres etapas diferentes de recuperación tras un ictus (subaguda, crónica a corto plazo y crónica a largo plazo) con función del brazo/mano deteriorada, fueron reclutados para usar el sistema MERLIN durante 3 semanas: 1 semana de entrenamiento en el Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), y 2 semanas en los domicilios de los pacientes. Para evaluar la usabilidad, se utilizó la Escala de Usabilidad del Sistema (SUS), el Inventario de Motivación Intrínseca Adaptada (IMI), la Evaluación de Usuario de Quebec de Satisfacción con la Tecnología Asistiva (QUEST) y el Cuestionario de Evaluación de Usabilidad de ArmAssist en el post-intervención. Se evaluaron los resultados clínicos de la función motora del miembro superior antes y después de la intervención. Proyecto Fesia Grasp: ensayo clínico con producto biosanitario controlado, aleatorizado y con evaluación ciega por terceros. 16 participantes en una fase de recuperación tras un ictus comprendida entre 1 y 8 meses, con afectación motora del miembro superior, fueron reclutados para completar 12 sesiones de rehabilitación. Los participantes fueron asignados aleatoriamente al grupo con Fesia Grasp o al grupo Control, ambos grupos con la misma duración de tratamieno. Las medidas de resultado, realizadas pre y post intervención, incluyeron la escala Fulg Meyer Assesment-upper extremity (FMA-UE), la escala de fuerza muscular modificada Medical Research Council (FMMMRC), la fuerza de agrre medida con dinamómetro, la escala modificada de Asworth (MAS) y la prueba de Box and Blocks Test (BBT). También se incluyó la escala IMI y una encuesta semiestructurada de usabilidad. Resultados: Proyecto Merlín: 9 pacientes completaron el estudio. Los resultados en la evaluación de usabilidad informaron de un alto nivel de satisfacción: puntuación media SUS 71,94 % (DE = 16,38), escala QUEST media 3,81 (DE = 0,38) y puntuación IMI adaptada media 6,12 (DE = 1,36). Los resultados del Cuestionario ArmAssist mostraron una media de 6 sobre 7, lo que indica que MERLIN es extremadamente intuitivo, fácil de aprender y fácil de usar. En cuanto a la evaluación clínica, las puntuaciones de Fugl-Meyer mostraron mejoras moderadas después de la intervención, en la puntuación total de la función motora (p = 0,002). No hubo cambios significativos en los resultados de la escala de Ashworth modificada (p = 0,169). Proyecto Fesia Grasp: 16 pacientes completaron el estudio. Tras 12 sesiones de rehabilitación, el grupo con Fesia Grasp obtiene diferencias significativas en todas las variables de la escala FMA-UE (muñeca p=0.005, mano p=0,022 y función motora total p=0,001), en 3 variables de la escala FMMMRC (flexión de muñeca p=0,007, extensión de muñeca p=0,033, flexión de dedos p=0,026) y en el BBT (p=0,036). El grupo control solo muestra diferencias significativas en la variable “mano” para la escala FMA-UE (p=0.014). Los resultados de la escala IMI y encuestas semiestructurada, muestran que la usabilidad del dispositivo es alta. Conclusiones: Proyecto Merlín: La rehabilitación domiciliaria de miembros superiores con el sistema MERLIN es factible, útil, segura y motivadora en pacientes con deterioro de la función motora del miembro superior después de sufrir un ictus. La viabilidad del sistema MERLIN como una solución de rehabilitación de bajo costo y fácilmente adaptable para su uso en el hogar, resalta su capacidad para impulsar la telerehabilitación, aumentar la intensidad de las terapias y fortalecer la autonomía del paciente durante su proceso de recuperación. Proyecto Fesia Grasp: Este estudio muestra que la aplicación de Fesia Grasp en la rehabilitación post-ictus es efectiva para mejorar la función motora, fuerza muscular y destreza manual a corto plazo del miembro superior distal. La alta repetitividad de movimientos durante las sesiones se vincula con resultados positivos, sugiriendo que la terapia asistida con FES potencia el aprendizaje motor. La usabilidad, la motivación de los participantes y la ausencia de eventos adversos respaldan la integración exitosa de Fesia Grasp en la práctica clínica.Introduction: Advances in neuroscience and neurotechnology are transforming stroke rehabilitation. Therapies assisted by advanced technologies are gaining increasing importance due to their ability to incorporate key elements for effective rehabilitation according to scientific evidence: intensity, repetition, early intervention, and the application of challenging, motivating, and function-centered therapies. In this context, devices like MERLIN (a serious game-based robotic system) and FESIA GRASP (a device based on functional electrical stimulation) could represent a significant advancement in upper limb neurorehabilitation for individuals with impaired motor function. In the research and application of advanced technologies within the biomedical field, the assessment of two factors becomes essential: usability and effectiveness. Usability studies are critical for successful implementation, as they largely determine the utility, feasibility, and acceptance of a technology or product. Effectiveness provides a solid assessment of the impact of these advanced technologies on clinical health outcomes, essential for understanding their true value and benefit in medical practice. Objectives: MERLIN Project: To evaluate the usability of the MERLIN device, as well as to demonstrate the feasibility of including this technology as a complement to a regular telerehabilitation program. To assess motivation and treatment adherence. Fesia Grasp Project: To evaluate the effectiveness in terms of upper limb motor recovery, comparing clinical outcomes following conventional therapies versus therapies assisted by advanced technologies. Materials and Methods: MERLIN Project: Clinical trial with a biomedical product, single-center, open-label, longitudinal, and uncontrolled. Nine participants at different stages of stroke recovery (subacute, short-term chronic, and long-term chronic) with impaired arm/hand function were recruited to use the MERLIN system for 3 weeks: 1 week of training at the Maimonides Biomedical Research Institute of Córdoba (IMIBIC), and 2 weeks at patients' homes. Usability was assessed using the System Usability Scale (SUS), the Intrinsic Motivation Inventory-Adapted (IMI), the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and the ArmAssist Usability Evaluation Questionnaire post-intervention. Clinical outcomes of upper limb motor function were evaluated before and after intervention. Fesia Grasp Project: Controlled clinical trial with a biomedical product, randomized, and blinded evaluation by third parties. Sixteen participants in the stroke recovery phase ranging from 1 to 8 months, with upper limb motor impairment, were recruited to complete 12 rehabilitation sessions. Participants were randomly assigned to the Fesia Grasp group or the Control group, both with the same treatment duration. Outcome measures, performed pre- and post-intervention, included the Fulg Meyer Assessment-upper extremity (FMA-UE) scale, modified Medical Research Council (MRC) muscle strength scale, grip strength measured with a dynamometer, modified Ashworth scale (MAS), and the Box and Blocks Test (BBT). The IMI scale and a semi-structured usability survey were also included. Results: MERLIN Project: 9 patients completed the study. Usability evaluation results reported a high level of satisfaction: mean SUS score 71.94% (SD = 16.38), mean QUEST scale 3.81 (SD = 0.38), and mean adapted IMI score 6.12 (SD = 1.36). ArmAssist Questionnaire results showed a mean score of 6 out of 7, indicating that MERLIN is extremely intuitive, easy to learn, and easy to use. Regarding clinical evaluation, Fugl-Meyer scores showed moderate improvements after intervention, in total upper limb motor function score (p = 0.002). There were no significant changes in modified Ashworth scale results (p = 0.169). Fesia Grasp Project: 16 patients completed the study. After 12 rehabilitation sessions, the Fesia Grasp group showed significant differences in all variables of the FMA-UE scale (wrist p = 0.005, hand p = 0.022, and total motor function p = 0.001), in 3 variables of the FMMMRC scale (wrist flexion p = 0.007, wrist extension p = 0.033, finger flexion p = 0.026), and in the BBT (p = 0.036). The control group only showed significant differences in the "hand" variable for the FMA-UE scale (p = 0.014). IMI scale results and semi-structured surveys showed high device usability Conclusions: MERLIN Project: Home-based upper limb rehabilitation with the MERLIN system is feasible, useful, safe, and motivating in patients with impaired upper limb motor function following a stroke. The viability of the MERLIN system as a low-cost, easily adaptable rehabilitation solution for home use highlights its ability to drive telerehabilitation, increase therapy intensity, and strengthen patient autonomy during the recovery process. Fesia Grasp Project: This study demonstrates that applying Fesia Grasp in post-stroke rehabilitation is effective in improving short-term distal upper limb motor function, muscle strength, and manual dexterity. The high repeatability of movements during sessions is linked to positive outcomes, suggesting that FES-assisted therapy enhances motor learning. Usability, participant motivation, and the absence of adverse events support the successful integration of Fesia Grasp into clinical practice

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

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

Background: 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. Methods: 9 participants with a stroke in three diferent stages of recovery (subacute, short-term chronic and long term chronic) with impaired arm/hand function, were recruited to use the MERLIN system for 3 weeks: 1 week training at the Maimonides Biomedical Research Institute of Cordoba (IMIBIC), and 2 weeks at the patients’ homes. To evaluate usability, the System Usability Scale (SUS), Adapted Intrinsic Motivation Inventory (IMI), Quebec User Evaluation of Satisfaction with assistive Technology (QUEST), and the ArmAssist Usability Assessment Questionnaire were used in the post-intervention. Clinical outcomes for upper limb motor function were assessed pre- and post-intervention. Results: 9 patients participated in and completed the study. The usability assessment reported a high level of satisfaction: mean SUS score 71.94% (SD=16.38), mean QUEST scale 3.81 (SD=0.38), and mean Adapted IMI score 6.12 (SD=1.36). The results of the ArmAssist Questionnaire showed an average of 6 out of 7, which indicates that MERLIN is extremely intuitive, easy to learn and easy to use. Regarding clinical assessment, the Fugl-Meyer scores showed moderate improvements from pre- to post-intervention in the total score of motor function (p=0.002). There were no signifcant changes in the Modifed Ashworth scale outcomes (p=0.169). Conclusions: This usability study indicates that home-based rehabilitation for upper limbs with the MERLIN system is safe, useful, feasible and motivating. Telerehabilitation constitutes a major step forward in the use of intensive rehabilitation at home.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.Ye