MUNDUS is an assistive framework for recovering direct interaction capability of severely motor impaired people based on arm reaching and hand functions. It aims at achieving personalization, modularity and maximization of the user’s direct involvement in assistive systems. To this, MUNDUS exploits any residual control of the end-user and can be adapted to the level of severity or to the progression of the disease allowing the user to voluntarily interact with the environment. MUNDUS target pathologies are high-level spinal cord injury (SCI) and neurodegenerative and genetic neuromuscular diseases, such as amyotrophic lateral sclerosis, Friedreich ataxia, and multiple sclerosis (MS). The system can be alternatively driven by residual voluntary muscular activation, head/eye motion, and brain signals. MUNDUS modularly combines an antigravity lightweight and non-cumbersome exoskeleton, closed-loop controlled Neuromuscular Electrical Stimulation for arm and hand motion, and potentially a motorized hand orthosis, for grasping interactive objects. The definition of the requirements and of the interaction tasks were designed by a focus group with experts and a questionnaire with 36 potential end-users. Five end-users (3 SCI and 2 MS) tested the system in the configuration suitable to their specific level of impairment. They performed two exemplary tasks: reaching different points in the working volume and drinking. Three experts evaluated over a 3-level score (from 0, unsuccessful, to 2, completely functional) the execution of each assisted sub-action. The functionality of all modules has been successfully demonstrated. User’s intention was detected with a 100% success. Averaging all subjects and tasks, the minimum evaluation score obtained was 1.13 ± 0.99 for the release of the handle during the drinking task, whilst all the other sub-actions achieved a mean value above 1.6. All users, but one, subjectively perceived the usefulness of the assistance and could easily control the system. Donning time ranged from 6 to 65 minutes, scaled on the configuration complexity. The MUNDUS platform provides functional assistance to daily life activities; the modules integration depends on the user’s need, the functionality of the system have been demonstrated for all the possible configurations, and preliminary assessment of usability and acceptance is promising.

Background and Purpose—: This study assessed whether cycling induced by functional electrical stimulation (FES) was more effective than passive cycling with placebo stimulation in promoting motor recovery and walking ability in postacute hemiparetic patients. Methods—: In a double-blind, randomized, controlled trial, 35 patients were included and randomized to receive FES-induced cycling training or placebo FES cycling. The 4-week treatment consisted of 20 sessions lasting 25 minutes each. Primary outcome measures included the leg subscale of the Motricity Index and gait speed during a 50-meter walking test. Secondary outcomes were the Trunk Control Test, the Upright Motor Control Test, the mean work produced by the paretic leg, and the unbalance in mechanical work between paretic and nonparetic legs during voluntary pedaling. Participants were evaluated before training, after training, and at 3- to 5-month follow-up visits. Results—: No significant differences were found between groups at baseline. Repeated-measures ANOVA ( P <0.05) revealed significant increases in Motricity Index, Trunk Control Test, Upright Motor Control Test, gait speed, and mean work of the paretic leg after training and at follow-up assessments for FES-treated patients. No outcome measures demonstrated significant improvements after training in the placebo group. Both groups showed no significant differences between assessments after training and at follow-up. A main effect favoring FES-treated patients was demonstrated by repeated-measures ANCOVA for Motricity Index ( P <0.001), Trunk Control Test ( P =0.001), Upright Motor Control Test ( P =0.005), and pedaling unbalance ( P =0.038). Conclusions—: The study demonstrated that 20 sessions of FES cycling training significantly improved lower extremity motor functions and accelerated the recovery of overground locomotion in postacute hemiparetic patients. Improvements were maintained at follow-up.

A real-time, adaptive algorithm based on two inertial and magnetic sensors placed on the shanks was developed for gait-event detection. For each leg, the algorithm detected the Initial Contact (IC), as the minimum of the flexion/extension angle, and the End Contact (EC) and the Mid-Swing (MS), as minimum and maximum of the angular velocity, respectively. The algorithm consisted of calibration, real-time detection, and step-by-step update. Data collected from 22 healthy subjects (21 to 85 years) walking at three self-selected speeds were used to validate the algorithm against the GaitRite system. Comparable levels of accuracy and significantly lower detection delays were achieved with respect to other published methods. The algorithm robustness was tested on ten healthy subjects performing sudden speed changes and on ten stroke subjects (43 to 89 years). For healthy subjects, F1-scores of 1 and mean detection delays lower than 14 ms were obtained. For stroke subjects, F1-scores of 0.998 and 0.944 were obtained for IC and EC, respectively, with mean detection delays always below 31 ms. The algorithm accurately detected gait events in real time from a heterogeneous dataset of gait patterns and paves the way for the design of closed-loop controllers for customized gait trainings and/or assistive devices.

To evaluate the effect on disability, kinesiophobia, pain, and the quality of life of a long-lasting multidisciplinary program based on cognitive-behavioral therapy and targeted against fear-avoidance beliefs in patients with chronic low back pain. parallel-group, randomized, superiority controlled study. Ninety patients were randomly assigned to a multidisciplinary program consisting of cognitive-behavior therapy and exercise training (experimental group, 45 patients) or exercise training alone (control group, 45 patients). Before treatment (T1), 5 weeks later (instructive phase, T2), and 12 (posttreatment analysis, T3) and 24 months after the end of the instructive phase (1-year follow-up, T4), all of the patients completed a booklet containing the Roland-Morris Disability Questionnaire Scale (primary outcome), the Tampa Scale for Kinesiophobia, a pain numerical rating scale, and the Short-Form Health Survey. A linear mixed model for repeated measures was used to analyze each outcome measure, and the reliable change index/clinically significant change method was used to assess the clinical significance of the changes. The linear mixed model analysis showed a remarkable group, time, and interaction effect for group * time in all of the primary and secondary outcomes (P always <0.001). The majority of the patients in the experimental group achieved a reliable and clinically significant improvement, whereas the majority of those in the control group experienced no change. The long-lasting multidisciplinary program was superior to the exercise program in reducing disability, fear-avoidance beliefs and pain, and enhancing the quality of life of patients with chronic low back pain. The effects were clinically tangible and lasted for at least 1 year after the intervention ended.