The efficacy of standard rehabilitative therapy for improving upper limb functions after stroke is limited; thus, alternative strategies are needed. Vagus nerve stimulation (VNS) paired with rehabilitation is a promising approach, but the invasiveness of this technique limits its clinical application. Recently, a noninvasive method to stimulate vagus nerve has been developed. The aim of the present study was to explore whether noninvasive VNS combined with robotic rehabilitation can enhance upper limb functionality in chronic stroke. Safety and efficacy of this combination have been assessed within a proof-of-principle, double-blind, semirandomized, sham-controlled trial. Fourteen patients with either ischemic or haemorrhagic chronic stroke were randomized to robot-assisted therapy associated with real or sham VNS, delivered for 10 working days. Efficacy was evaluated by change in upper extremity Fugl–Meyer score. After intervention, there were no adverse events and Fugl–Meyer scores were significantly better in the real group compared to the sham group. Our pilot study confirms that VNS is feasible in stroke patients and can produce a slight clinical improvement in association to robotic rehabilitation. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable. Further studies are needed to confirm the efficacy of this innovative approach.
Previous studies suggested that both robot-assisted rehabilitation and non-invasive brain stimulation can produce a slight improvement in severe chronic stroke patients. It is still unknown whether their combination can produce synergistic and more consistent improvements. Safety and efficacy of this combination has been assessed within a proof-of-principle, double-blinded, semi-randomized, sham-controlled trial. Inhibitory continuous Theta Burst Stimulation (cTBS) was delivered on the affected hemisphere, in order to improve the response to the following robot-assisted therapy via a homeostatic increase of learning capacity. Twenty severe upper limb-impaired chronic stroke patients were randomized to robot-assisted therapy associated with real or sham cTBS, delivered for 10 working days. Eight real and nine sham patients completed the study. Change in Fugl-Meyer was chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes. The treatment was well-tolerated by the patients and there were no adverse events. All patients achieved a small, but significant, Fugl-Meyer improvement (about 5%). The difference between the real and the sham cTBS groups was not significant. Among several secondary end points, only the Success Rate (percentage of targets reached by the patient) improved more in the real than in the sham cTBS group. This study shows that a short intensive robot-assisted rehabilitation produces a slight improvement in severe upper-limb impaired, even years after the stroke. The association with homeostatic metaplasticity-promoting non-invasive brain stimulation does not augment the clinical gain in patients with severe stroke.
Today neurological diseases such as stroke represent one of the leading cause of long-term disability. Many research efforts have been focused on designing new and effective rehabilitation strategies. In particular, robotic treatment for upper limb stroke rehabilitation has received significant attention due to its ability to provide high-intensity and repetitive movement therapy with less effort than traditional methods. In addition, the development of non-invasive brain stimulation techniques such as transcranial Direct Current Stimulation (tDCS) has also demonstrated the capability of modulating brain excitability thus increasing motor performance. The combination of these two methods is expected to enhance functional and motor recovery after stroke; to this purpose, the current trends in this research field are presented and discussed through an in-depth analysis of the state-of-the-art. The heterogeneity and the restricted number of collected studies make difficult to perform a systematic review. However, the literature analysis of the published data seems to demonstrate that the association of tDCS with robotic training has the same clinical gain derived from robotic therapy alone. Future studies should investigate combined approach tailored to the individual patient's characteristics, critically evaluating the brain areas to be targeted and the induced functional changes.
The design of patient-tailored rehabilitative protocols represents one of the crucial factors that influence motor recovery mechanisms, such as neuroplasticity. This approach, including the patient in the control loop and characterized by a control strategy adaptable to the user's requirements, is expected to significantly improve functional recovery in robot-aided rehabilitation. In this paper, a novel 3D bio-cooperative robotic platform is developed. A new arm-weight support system is included into an operational robotic platform for 3D upper limb robot-aided rehabilitation. The robotic platform is capable of adapting therapy characteristics to specific patient needs, thanks to biomechanical and physiological measurements, and thus closing the subject in the control loop. The level of arm-weight support and the level of the assistance provided by the end-effector robot are varied on the basis of muscular fatigue and biomechanical indicators. An assistance-as-needed approach is applied to provide the appropriate amount of assistance. The proposed platform has been experimentally validated on 10 healthy subjects; they performed 3D point-to-point tasks in two different conditions, i.e., with and without assistance-as-needed. The results have demonstrated the capability of the proposed system to properly adapt to real needs of the patients. Moreover, the provided assistance was shown to reduce the muscular fatigue without negatively influencing motion execution.
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