Lower limb amputees use prostheses that do not restore sensory feedback during walking. The lack of feedback increases the risk of falls of amputee, who lose confidence in the prosthesis, overusing the healthy leg, have increased fatigue, and reduced mobility. Finally, they do not feel the device as part of the body and experience phantom limb pain (pain from the missing limb). Because of these reasons, users abandon the prosthesis, with consequent low reinsertion into the working society. SensArs has developed the solution to these problems: a neuroprosthesis that allows amputees to feel sensory feedback from the prosthesis as from a real leg. So far, 3 amputees have tested its technology. The main goal of GoSafe is to improve the device and finalize a pilot trial proving safety and efficacy. The pilot trial will give insights on potential technology or clinical protocol modifications to go through a pivotal study to get CE mark for the neuroprosthesis. To reach this goal, SensArs will optimize the neuroprosthesis and integrate it with the commercial prosthetic leg of Össur, then will go through preclinical validation and clinical pilot study at UCSC and CHAR with leg amputees. With the clinical pilot study, SensArs will apply for a pivotal study for CE mark (class III device), which will allow commercialization after the project. To guarantee the product market uptake, the consortium will run during the project a study to define the strategy to get reimbursement right after the CE marking. There are no commercial devices similar to the one proposed in GoSafe. The prosthesis restoring sensory feedback will enable users to feel the prosthesis itself as part of the body, to avoid falls, and so to increase confidence in the device, which will reduce counterbalancing movements, and fatigue. The GoSafe neuroprosthesis would be a novel therapy for phantom pain and would enable the National Health Systems to save up to €330’000 per amputee, connected to a sedentary lifestyle following prosthesis abandonment. The sensory feedback system will represent a new product in the prosthetics market (valued €1.4 billion in 2016), allowing its further expansion.

Current brain and neural interfacing technologies still face significant limitations to become accessibility tools that can benefit people. On the one hand, non-invasive neural interface technology (e.g. EEG, EMG) is intrinsically unidirectional and of limited capacity. On the other hand, invasive technology (e.g. percutaneous EMG, implanted nerve electrodes or intracranial electroencephalography) while allowing two-directionality and better performance still relies on complex surgical procedures. EXTEND aims at developing the novel concept of Bidirectional Hyper-Connected Neural Systems (BHNS) to extend the capabilities of neural interfaces with minimally invasive communication links between multiple nerves in the body and multiple external devices. EXTEND will realise BHNS by developing disruptive wireless neuromuscular (injectable) interface technology that enables distributed stimulation, sensing, processing and analysis of neuromuscular activity, the ultimate stance of the neural code of movement. The EXTEND project will showcase the advantages of this new technology in two applications: (1) tremor management in essential tremor (ET) and Parkinson disease (PD), and (2) neural interfaced assistive wearable robots for spinal cord injury (SCI). EXTEND will also work towards a community hub that brings together stakeholders to create an innovation ecosystem that can nurture the fast development of neural interfaces around the new concept.

The main challenge that INBOTS wants to overcomes is the lack of a clear understanding and communication between all the involved stakeholders. These limitations hinder current efforts to successfully discuss and agree on the many important technical and non-technical aspects in the field. Therefore, with the purpose of optimizing the outcomes of the coordinate and support action, INBOTS will focus mainly on Interactive Robots, which we define as any robot that is interacting in close proximity with humans. In this context, the overall objective of this project is to create a community hub that can bring together experts to debate and create a responsible research and innovation paradigm for robotics. To this end, INBOTS provides a platform to establish a working synergy between four pillars that covers all stakeholders in Interactive Robotics: the technical expertise pillar, the business expertise pillar, the ethical, legal and socioeconomic expertise pillar, as well as the end-users, policy makers and general public pillar. Therefore, the project strives at coordinating and supporting actions aimed at building bridges among these pillars to promote debate and create a responsible research and innovation paradigm that will potentiate EU leadership on robotics. INBOTS CSA is relevant to the H2020 Topic ICT 28-2017: “Robotics Competitions, coordination and support”, scope a) “Non-technical barriers to robotics take-up”; b) “Standards and Regulation”; and c) “Community support and outreach”. Through a coordination and support action the INBOTS CSA consortium will build and support a strong European community based on the collaboration between all stakeholders. The project will serve as a platform for sharing experiences and accelerate the technology transfer, regulation and legislation in the field.

Limb amputations cause serious physical disabilities that compromise the quality of life of many people around the globe. There are 40 million amputees in the world with an estimated 2.4 million in the EU and approximately 215,000 amputation surgeries performed each year (around 90% are lower limb amputees). Thus, there is a growing demand for efficient prosthetic socket systems due to growing number of amputees and lack of an existing solution for the comfortable socket. This project aims to develop a new solution for a prosthetic socket by developing wearable sensors to be embedded in a socket for the amputee patients to wear in everyday life. The sensors will allow real-time data collection allowing prosthetist to monitor the evolution of the performance of existing socket as well as the anatomical changes of the residual limb of amputees. New algorithms will be developed to evaluate all the biomechanical characteristics so that once the existing socket does not serve the patient, a new socket will be produced automatically without the need for the patient to go to a clinic in advance. SocketSense will meet this healthcare need by means of sensors, biomechanical modeling, AI, unified software and additive manufacturing technologies. The sensors will be developed based on QTSS materials (patent protected under WO2017103592A1). Biomechanical analytical models will be developed to turn the sensor data into optimized socket design. The whole SocketSense technique and procedure will be validated through clinical trials. The proposed solution will help address the societal challenge of personalized health and care solution for the population of lower-limb amputees. The project will implement flexible and wearable electronics into new QTSS material fabricating lightweight, flexible, printed and multi-functional electronic sensors to be embedded in prosthetic socket system. The development in the project will address market demand worth €1.76 billion by 2021.

The global goal of the CYBERLEGs Plus Plus project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed within the framework of the FP7-ICT-CYBERLEGs project as a means to enhance/restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks such as ground-level walking, walking up and down slopes, climbing/descending stairs, standing up, sitting down and turning in scenarios of real life. Restored mobility will allow amputees to perform physical activity thus counteracting physical decline and improving the overall health status and quality of life. This consortium will pursue the achievement of the global goal by addressing four specific innovation objectives. 1) Further developments of the existing CYBERLEGs hardware modules, namely the 2-degree-of-freedom active transfemoral prosthesis, the active wearable orthotic device, and the wearable sensory apparatus. 2) Further developments of the existing multi-layered CYBERLEGs control system, to enhance its reliable use in real-life scenarios. 3) Carrying out two multi-centre clinical studies, that validate the therapeutic potentialities and the economic viability of a robotic ortho-prosthesis which restores the amputees’ locomotion abilities in scenarios of activities of daily living. 4) Implementation of a 3-phase strategy to foster the start of the market exploitation within the time frame of the CLs++ project. This proposal focuses on the demonstration in an operational environment (TRL=7) from both the technical and economic viability view point of a modular robotics technology for healthcare, with the ultimate goal of fostering its market exploitation. The proposals involve players from academia, end users, as well as robotics and healthcare industry. Therefore this proposal fits the specific challenge of the scope c of the call H2020-ICT-25-2016-2017.