Marialuisa Gandolfi1, Nicola Valè2, Federico Posteraro3, Giovanni Morone4, Antonella Dell'orco5, Anita Botticelli5, Eleonora Dimitrova2, Elisa Gervasoni6, Michela Goffredo7, Jacopo Zenzeri8, Arianna Antonini9, Carla Daniele10, Paolo Benanti11, Paolo Boldrini12, Donatella Bonaiuti13, Enrico Castelli14, Francesco Draicchio15, Vincenzo Falabella16, Silvia Galeri6, Francesca Gimigliano17, Mauro Grigioni18, Stefano Mazzon19, Franco Molteni20, Maurizio Petrarca21, Alessandro Picelli5, Michele Senatore22, Giuseppe Turchetti23, Daniele Giansanti18, Stefano Mazzoleni24. 1. Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Neurorehabilitation Unit, University Hospital of Verona, Italy - marialuisa.gandolfi@univr.it. 2. Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Verona, Italy. 3. Rehabilitation Department Versilia Hospital, ASL Toscana Nord-Ovest, Italy. 4. Santa Lucia Foundation, IRCCS, Rome, Italy. 5. Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Neurorehabilitation Unit, University Hospital of Verona, Italy. 6. IRRCS don Carlo Gnocchi Foundation, Milan, Italy. 7. Neurorehabilitation Research Laboratory, Department of Neurological and Rehabilitation Sciences, IRCCS San Raffaele Pisana, Rome, Italy. 8. Robotics, Brain and Cognitive Sciences, Istituto Italiano di Tecnologia, Genova, Italy. 9. AITO Umbria coordinator, Italy. 10. Istituto Superiore di Sanità, Rome, Italy. 11. Pontifical Gregorian University, Rome, Italy. 12. Italian Society of Physical Medicine and Rehabilitation (SIMFER), Italy. 13. Geriatric Institute Piero Redaelli, Milan, Italy. 14. Pediatric Neurorehabilitation, Bambino Gesù Children's Hospital, Rome, Italy. 15. Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, INAIL, Rome, Italy. 16. President Italian Federation of Persons with Spinal Cord Injuries (Flip Onlus), Rome, Italy. 17. Department of Mental and Physical Health and Preventive Medicine, University of Campania "Luigi Vanvitelli, " Naples, Italy. 18. National Center for Innovative Technologies in Public Health, Italian National Institute of Health, Rome, Italy. 19. ULSS 6 (Unique Sanitary Local Company) Euganea Padova - Distretto IV Alta Padovana, Padova, Italy. 20. Villa Beretta, Costa Masnaga, Como, Italy. 21. The Movement Analysis and Robotics Laboratory, Bambino Gesù Children's Hospital, Rome, Italy. 22. AITO (Italian Association of Occupational Therapists). 23. Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy. 24. Department of Electrical and Information Engineering, Politecnico di Bari, Italy.
Abstract
INTRODUCTION: The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyse the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems. EVIDENCE ACQUISITION: Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated. EVIDENCE SYNTHESIS: Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults). CONCLUSIONS: The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.
INTRODUCTION: The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyse the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems. EVIDENCE ACQUISITION: Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated. EVIDENCE SYNTHESIS: Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults). CONCLUSIONS: The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.