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Background Robotic systems combined with Functional Electrical Stimulation (FES) showed promising results on upper-limb motor recovery after stroke, but adequately-sized randomized controlled trials (RCTs) are still missing. Objective To evaluate whether arm training supported by RETRAINER, a passive exoskeleton integrated with electromyograph-triggered functional electrical stimulation, is superior to advanced conventional therapy (ACT) of equal intensity in the recovery of arm functions, dexterity, strength, activities of daily living, and quality of life after stroke. Methods A single-blind RCT recruiting 72 patients was conducted. Patients, randomly allocated to 2 groups, were trained for 9 weeks, 3 times per week: the experimental group performed task-oriented exercises assisted by RETRAINER for 30 minutes plus ACT (60 minutes), whereas the control group performed only ACT (90 minutes). Patients were assessed before, soon after, and 1 month after the end of the intervention. Outcome measures were as follows: Action Research Arm Test (ARAT), Motricity Index, Motor Activity Log, Box and Blocks Test (BBT), Stroke Specific Quality of Life Scale (SSQoL), and Muscle Research Council. Results All outcomes but SSQoL significantly improved over time in both groups ( P < .001); a significant interaction effect in favor of the experimental group was found for ARAT and BBT. ARAT showed a between-group change of 11.5 points ( P = .010) at the end of the intervention, which increased to 13.6 points 1 month after. Patients considered RETRAINER moderately usable (System Usability Score of 61.5 ± 22.8). Conclusions Hybrid robotic systems, allowing to perform personalized, intensive, and task-oriented training, with an enriched sensory feedback, was superior to ACT in improving arm functions and dexterity after stroke.

Objective: To develop and evaluate a hybrid robotic system for arm recovery after stroke, combining ElectroMyoGraphic (EMG)-triggered functional electrical stimulation (FES) with a passive exoskeleton for upper limb suspension. Methods: The system was used in a structured exercise program resembling activities of daily life. Exercises execution was continuously controlled using angle sensor data and radio-frequency identification technology. The training program consisted of 27 sessions lasting 30 min each. Seven post-acute stroke patients were recruited from two clinical sites. The efficacy of the system was evaluated in terms of action research arm test, motricity index, motor activity log, and box & blocks tests. Furthermore, kinematics-based and EMG-based outcome measures were derived directly from data collected during training sessions. Results: All patients showed an improvement of motor functions at the end of the training program. After training, the exercises were in most cases executed faster, smoother, and with an increased range of motion. Subjects were able to trigger FES, but in some cases, they did not maintain the voluntary effort during task execution. All subjects but one considered the system usable. Conclusion: The preliminary results showed that the system can be used in a clinical environment with positive effects on arm functional recovery. However, only the final results of the currently ongoing clinical trial will unveil the system's full potential. Significance: The presented hybrid robotic system is highly customizable, allows to monitor the daily performance, requires low supervision of the therapist, and might have the potential to enhance arm recovery after stroke.

The RETRAINER S1 system is an upper limb rehabilitation device designed to be used in repetitive task-oriented training. While the device itself is intrinsically controlled by the wearer, the execution of the training exercises is automatically controlled by a finite-state machine. This contribution discusses three different control strategies tested in a clinical environment.

Collaborations between universities and industry are a driving force for innovation. While the benefits for both parties involved in such collaboration are numerous, so are the challenges that come with it. This paper shines a light on both – benefits and challenges - experienced in the H2020 project RETRAINER, a multi-national project in the strongly regulated field of medical devices.

Stroke is the main cause of permanent and complex long-term disability in adults. RETRAINER S2 is a system able to recover and support person’s ability to perform Activities of Daily Living (ADL) in early stage after stroke. The system is based on exercises for hand and wrist performed using Neuro Muscular Electrical Stimulation (NMES). This work describes the preliminary results of a multi-center Randomized Controlled Trial (RCT) aimed at evaluating effectiveness of the system. The preliminary results were calculated on 18 patients who completed the protocol. Data is promising, the RETRANER S2 system seems to be a good tool for stroke rehabilitation. Data confirms also a general good usability of the system.

This work presents the preliminary results of a randomized controlled trial aimed at evaluating the efficacy of a novel hybrid robotic system for arm rehabilitation after stroke. The system was developed within the European project RETRAINER and consists of a passive exoskeleton for weight relief combined with an arm EMG-triggered neuroprosthesis. Up to now, 39 patients completed the 9-week intervention: patients in the experimental group achieved a significantly better effect in the motoric outcome measures with respect to control subjects receiving only conventional therapy. These promising results need to be confirmed on a larger sample.

Introduction/Background Stroke is the main cause of acquired adult disability with major impact on arm function. The combined use of Functional Electrical Stimulation (FES) and robotic technologies is strongly advocated to improve rehabilitation outcomes after stroke. We present the preliminary data of a multi-center Randomized Controlled Trial aimed at evaluating the effectiveness of this system with respect to conventional therapy for sub-acute stroke upper limb rehabilitation. Material and method The RETRAINER system consists of a lightweight and non-cumbersome passive arm exoskeleton for weight relief, a current-controlled stimulator with 2 channels of stimulation and 2 channels of EMG recordings. In this work we are presenting the preliminary results of 39 sub-acute stroke patients with a distance from the acute event between two weeks and nine months. The inclusion criteria was: age between 18 and 85 years, Motricity Index (MI) Results Results are showed in the next Table 1 . Conclusion Both groups showed statistical improvement in outcome measures. Experimental group showed a statistical better improvement regarding time and group effect.