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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 3 - RETRAINER (REaching and grasping Training based on Robotic hybrid AssIstance for Neurological patients: End users Real life evaluation)

Teaser

Summary

The overall aim of the RETRAINER project is to tune and validate advanced, robot-based technologies to facilitate recovery of arm and hand function in stroke survivors and to extensively verify the use of the system by patients and clinicians. RETRAINER allows end-users to use their own arm and hand as much and as soon as possible after the trauma so to achieve the best outcomes in rehabilitation.
Every year, about 16 million first ever strokes occur in the world, causing 5.7 million deaths. As a consequence, stroke ranks as the second cause of death in the world population. In the EU, total annual cost of stroke is estimated â‚¬27 billion. A further sum of â‚¬11.1 billion is calculated for the value of informal care.
RETRAINER, as an innovation action, implements a full technology transfer from the results of a previous FP7 project, MUNDUS. RETRAINER makes available two systems for stroke rehabilitation, both derived from a subset of the MUNDUS project: S1, which aims at training the arm movements, and S2, which aims at training the hand movements.
RETRAINER S1 provides the end-user with a robot that does not completely take over the userâ€™s tasks and does not substitute the bodyâ€™s functionality, but specifically supports the user only wherever he/she really needs support. Residual functionality is trained and improved rather than replaced by the robotic device. Arm movements are supported by a combined action of a passive exoskeleton for weight relief and NMES delivered to arm muscles in a controlled manner. Stimulation amplitudes control is based on the residual EMG activities of the same stimulated muscles since the combination of NMES with the voluntary effort of the patients seems to maximize the therapeutic effects of NMES.
RETRAINER S2 takes care of the training of hand functions through a wearable NMES system with multiple electrode arrays, a modular tool usable as a platform for grasp rehabilitation, potentially improving the clinical applicability of NMES. The device is designed for providing electrical stimulation on extrinsic and intrinsic grasp muscles. The stimulation patterns can be manually tuned to elicit functional grasp, to obtain whole muscle conditioning, and to produce open-loop or closed-loop grasp control.
Both systems benefit from the use of interactive objects that are daily life objects able to supply the robotic system with some information on themselves (e.g. physical characteristics, expected sequence of use) to drive their usage. Within RETRAINER, this concept is exploited to drive rehabilitation exercises to get deeper knowledge on the recovery of the patient.
The S1 and S2 systems have been validated through a multicentre clinical trial conducted in Italy and Germany on 136 patients. The trial aimed at assessing the effectiveness of the RETRAINER rehabilitation systems against the conventional therapy on one side, and at evaluating the usability of the protypes in daily practice in clinical environment. The results showed that the S1 training has superior effects and S2 a comparable effect with respect to the conventional therapy. On the usability side, the two system have been extensively used for over 2 years autonomously by therapists in their daily activities, showing a high degree of robustness and easiness of use.

Work performed

The project started on January 2015 and it lasted 51 months. The development and manufacturing of the prototypes was completed successfully and they have been used in the two clinical centers in Italy and Germany for over 2 years.
From the technical point of view, most of activities were devoted to the finalization and tuning of the RETRAINER system specifications by clinicians and its acceptance by patients, the partial redesign and development of the S1 and S2 systems and the development of the system graphical user interface (GUI). The project aimed to build on the results of a previous project, MUNDUS. However the RETRAINER developers had to cope with the obsolescence of some of the MUNDUS technologies.
The following components were revised, developed, and manufactured as working prototypes: a 3 degrees of freedom lightweight exoskeleton able to compensate the weight of the enduser both at the arm and forearm level and to lock individually each of the three degrees of freedom; a portable stimulator able to both induce muscles contractions and measure the electromyographic signals of the stimulated muscles; an embedded platform controlling the exoskeleton and the stimulator in real time and collecting EMG signals, angle data from the exoskeleton, and force and position data from the hand; a GUI to drive the therapist during the donning and calibration of the S1 and S2 systems and the end-user during the training session; interactive objects to drive the exercise execution by information such as the proximity of the hand to the objects.
On the clinical trials side, preparatory activities included the identification of potential end-users; the definition of a set of exercises to perform; the investigation of potential end-users needs and cautions to be taken into account to optimize the design and production of both S1 and S2; the design and implementation of the pilot tests; the design of the usability trial in a clinical setting.
The trials were completed in March 2019, having reached the expected goal of 136 patients treated. The outcomes showed that performing rehabilitation therapy with S1 and S2 have effects superior and comparable with the conventional therapy respectively.
The information collected about the usage of the prototypes during the first year of the trials were exploited to further refine and make more robust and easy to use the two systems.
The RETRAINER project, thus, resulted in the effective technology transfer of the previous MUNDUS project to two rehabilitation subsystems and their production and validation in a multicentre clinical trial. The stimulator and the interactive objects have been exploited as standalone products by HASOMED and ABACUS, the two SMEs participating to the project.
The results of the projects have been largely disseminated to the scientific, industrial and civil society through over 20 publications, the participation to exhibitions and trade fares, press releases, and social media communications.

Final results

The results obtained by RETRAINER pushed the knowledge about robotic rehabilitation a step forward. Indeed, for the first time a robotic system exploiting the reinforcement effect of voluntariness and NMES synchronization has been fully validated on a large number of patients, showing the beneficial effect of this system on the upper limb rehabilitation after stroke.
Indeed, even if the exploitation of S1 and S2 systems has not occurred during in the project framework, major steps toward close-to-the-market products have been undertaken. The interest of the industrial community to the RETRAINER subsystems confirms the impact of the project on the industry of rehabilitation robotics.
The two SMEs involved in the project are already actively exploiting system submodules. In particular NMES is of interest to HASOMED and interactive objects are of interest to ABACUS.Moreover, algorithms for EMG triggering and analysis even during electrical stimulation, as well as array electrodes for electrical stimulation, seem interesting and could either be marketed as part of a complete system (as demonstrated in RETRAINER) or stand-alone technologies.