Clinical Validation of AuReha: A Wearable System for Upper-Limb Data-Driven Rehabilitation

Clinical Validation of AuReha: A Wearable System for Upper-Limb Data-Driven Rehabilitation Camilla Larini, DigitalRehab Milan, Italy [email protected] Silvia Sciamanna, DigitalRehab Milan, Italy [email protected] Lorenzo Valente, DigitalRehab Milan, Italy [email protected] Eugenio Luciani, DigitalRehab Milan, Italy [email protected] Giuseppe Recchia, DigitalRehab Milan, Italy davidigitalmedici[email protected] Gualberto Gussoni Fondazione RIDE2Med Milan, Italy [email protected] Stefania Frasson Fondazione RIDE2Med Milan, Italy [email protected] Alice Ravizza InsideAI Bologna, Italy [email protected] Abstract — AuReha is an intelligent wearable system for upper-limb rehabilitation, integrating inertial sensors, serious games, and a web platform for remote monitoring. Its clinical validation, designed under Medical Device Regulation (MDR) 2017/745, includes accuracy, usability, and proprioception studies with healthy volunteers, patients, and clinicians. This rigorous approach aims to generate robust clinical evidence supporting safe and effective adoption in healthcare. Keywords — wearable sensor devices, clinical evidence validation, upper-limb rehabilitation I. INTRODUCTION In recent years, digital health technologies have emerged as key enablers of innovation in rehabilitation, aiming to improve patient outcomes and ensure continuity of care. Wearable devices, robotics, and interactive applications have shown significant potential in supporting functional recovery, enhancing adherence to therapy, and enabling remote monitoring of rehabilitation progress. However, despite the wide availability of new solutions, a persistent lack of robust clinical evidence remains a major obstacle to their widespread adoption. Many digital tools are marketed as revolutionary, but they are not always supported by reliable scientific data, posing risks not only for patients, but also for healthcare professionals and facilities evaluating their adoption. Without objective and rigorous validation for evidence of clinical effectiveness and safety, even the most promising technologies risk remaining underutilized opportunities [1]. Within healthcare, devices and digital tools intended to support the care process must demonstrate their reliability through objective clinical evidence. For digital rehabilitation solutions, which often address sensitive aspects such as movement, remote monitoring, or functional recovery, clinical evidence is even more crucial. Scientifically validating a technology entails not only demonstrating its clinical effectiveness but also ensuring safety, appropriateness, and usability in real clinical contexts. The absence of adequate validation represents a risk for the patient and a barrier to large-scale adoption by healthcare systems [2]. The entry into force of the European MDR 2017/745 has made the regulatory framework both clearer and more stringent. Market entry for medical devices now demands strict adherence to clinical evaluation, risk management, and post-market surveillance requirements. This demands a systematic commitment from manufacturers from the early stages of the Research and Development phase, with the definition of structured clinical validation pathways following high ethical and scientific standards [3]. In digital rehabilitation, technological innovation and scientific rigor shall progress in parallel: data collection, comparison with established protocols, and stakeholder engagement must be integral to design. This approach helps prevent and mitigates inefficiencies, regulatory delays, and clinical risks while facilitating more rapid, sustainable adoption in practice. Within this context lies AuReha, an intelligent system developed for monitoring and supporting upper-limb rehabilitation therapies, currently undergoing CE certification as a Class IIa medical device. The system combines a sensorized shirt with integrated inertial sensors that detect movements and transmit them to a serious games app. Therapists monitor progress through a web platform and can access movement data remotely, fostering continuity, adherence, and quality of care. AuReha allows asynchronous remote monitoring of non-vital functional parameters, such as joint angles, jerk values, and movement trajectories, providing healthcare professionals with useful data to personalize therapeutic pathways and support clinical decision-making. II. METHODS The clinical validation pathway of AuReha was designed in full compliance with the requirements of EU MDR 2017/745 and supported by the implementation of a Quality Management System conforming to ISO 13485:2021. Following successful electromagnetic, electrical, and biocompatibility safety testing, a series of clinical studies was initiated across national centers of excellence, each protocol being conducted in a different site with its own methodological design. Protocols involve both healthy volunteers, to assess instrumental accuracy, and patients with 2025 I-RIM Conference October 17-19, Rome, Italy ISBN: 9788894580570 10.5281/zenodo.17629774 143 musculoskeletal and neuromotor impairments, together with healthcare professionals, to validate use in real clinical settings. Data collection includes comparison with traditional clinical practice tools, such as goniometers and video analysis systems, as well as standardized questionnaires (SUS, UESSF, HSUS) and dedicated rating scales developed to gather feedback on usability, clarity of instructions, engagement, and device comfort. III. RESULTS The strategic design of the validation pathway was structured into three main clinical protocols. The first aims to verify the accuracy of the AuReha system in motion monitoring, comparing data from the sensorized shirt with those collected by standard clinical care instrument (goniometer) and by a video analysis system. This comparison is fundamental to demonstrate that AuReha can provide precise measurements of rehabilitative movements. During this phase, the correct and timely transmission of data to the dedicated software platform will also be assessed. At the same time, usability and wearability of the sensorized shirt will be evaluated, focusing on user comfort and ease of use, which are essential for adoption in daily practice. The second study protocol also includes the goal of supporting therapy delivery for enrolled users: it involves sixteen healthcare professionals and sixteen patients with musculoskeletal and neuromotor deficits caused by orthopaedic conditions or neuromotor diseases. This protocol is designed to test AuReha in the real context of clinical rehabilitation, validating its ability to actively support rehabilitation therapy. Wearability of the shirt and quality of data collected during rehabilitation sessions will be assessed, comparing them with those obtained through traditional rehabilitation protocols. Another crucial aspect investigated in this protocol will be the timeliness of data transmission to therapists, a key element to ensure continuous and personalized therapy monitoring. The third clinical protocol foresees an intrasubject study to evaluate proprioception in patients with unilateral upper-limb deficits, addressing a scientific gap related to the lack of shared and standardized tools for measuring proprioceptive deficits. IV. DISCUSSION AuReha represents an example of intelligent wearable technology, integrating into a single solution all the components needed to enable objective assessment and interactive support of the therapeutic pathway: inertial sensors, processing algorithms, software platforms, and user interfaces. The ability to detect patient movements, process them in real time, and provide feedback through a virtual environment transforms raw data into clinically relevant information. The use of serious games enhances patient engagement, increasing motivation and improving therapy adherence, in line with gamification principles in rehabilitation, which have been shown to positively impact clinical outcomes and patient participation [4]. The validation strategy, structured and compliant with European regulatory standards, aims to generate solid clinical evidence supporting adoption of the system in real healthcare settings. Clinical study results will also provide useful clinical outcomes for future developments and guide the device’s use in a more specific and optimized manner. Looking forward, AuReha has the potential to become a reference medical device for upper-limb proprioceptive assessment and rehabilitation, promoting a more personalized, scalable, and data-driven therapeutic approach. Furthermore, the innovation introduced by AuReha demonstrates how wearable devices without actuators can be included within the field of intelligent machines and deliver significant clinical and scientific impact. REFERENCES [1] Guo C, Ashrafian H, Ghafur S, Fontana G, Gardner C, Prime M. Challenges for the evaluation of digital health solutions: a call for innovative evidence generation approaches. NPJ Digit Med. 2020 Aug 27;3:110. [2] Gomis-Pastor M, Alarcón F, Lozano-Ruiz C, Sabaté A, Roca J. Clinical validation of digital healthcare solutions: state of the art, challenges and opportunities. Healthcare (Basel). 2024 May 22;12(11):1057. [3] Medical Device Coordination Group (MDCG). MDCG 2020-1: guidance on clinical evaluation (MDR) for medical device software. European Commission, Directorate-General for Health and Food Safety. 2020. [4] Vieira C, Ferreira da Silva Pais-Vieira C, Novais J, Perrotta A. Serious game design and clinical improvement in physical rehabilitation: systematic review. JMIR Serious Games. 2021 Sep 23;9(3):e20066. 144