Robotic systems for upper-limb rehabilitation in multiple sclerosis: a SWOT analysis and the synergies with virtual and augmented environments.

The robotics discipline is exploring precise and versatile solutions for upper-limb rehabilitation in Multiple Sclerosis (MS). People with MS can greatly benefit from robotic systems to help combat the complexities of this disease, which can impair the ability to perform activities of daily living (ADLs). In order to present the potential and the limitations of smart mechatronic devices in the mentioned clinical domain, this review is structured to propose a concise SWOT (Strengths, Weaknesses, Opportunities, and Threats) Analysis of robotic rehabilitation in MS. Through the SWOT Analysis, a method mostly adopted in business management, this paper addresses both internal and external factors that can promote or hinder the adoption of upper-limb rehabilitation robots in MS. Subsequently, it discusses how the synergy with another category of interaction technologies - the systems underlying virtual and augmented environments - may empower Strengths, overcome Weaknesses, expand Opportunities, and handle Threats in rehabilitation robotics for MS. The impactful adaptability of these digital settings (extensively used in rehabilitation for MS, even to approach ADL-like tasks in safe simulated contexts) is the main reason for presenting this approach to face the critical issues of the aforementioned SWOT Analysis. This methodological proposal aims at paving the way for devising further synergistic strategies based on the integration of medical robotic devices with other promising technologies to help upper-limb functional recovery in MS.

Human-Centered Functional Task Design for Robotic Upper-Limb Rehabilitation.

Robotic rehabilitation has demonstrated slight positive effects compared to traditional care, but there is still a lack of targeted high-level control strategies in the current state-of-the-art for minimizing pathological motor behaviors. In this study, we analyzed upper-limb motion capture data from healthy subjects performing a pick-and-place task to identify task-specific variability in postural patterns. The results revealed consistent behaviors among subjects, presenting an opportunity to develop a novel extraction method for variable volume references based solely on observations from healthy individuals. These human-centered references were tested on a simulated 4 degrees-of-freedom upper-limb exoskeleton, showing its compliant adaptation to the path considering the variance in healthy subjects' motor behavior.

Object stiffness recognition and vibratory feedback without ad-hoc sensing on the Hannes prosthesis: A machine learning approach.

Introduction: In recent years, hand prostheses achieved relevant improvements in term of both motor and functional recovery. However, the rate of devices abandonment, also due to their poor embodiment, is still high. The embodiment defines the integration of an external object - in this case a prosthetic device - into the body scheme of an individual. One of the limiting factors causing lack of embodiment is the absence of a direct interaction between user and environment. Many studies focused on the extraction of tactile information via custom electronic skin technologies coupled with dedicated haptic feedback, though increasing the complexity of the prosthetic system. Contrary wise, this paper stems from the authors' preliminary works on multi-body prosthetic hand modeling and the identification of possible intrinsic information to assess object stiffness during interaction. Methods: Based on these initial findings, this work presents the design, implementation and clinical validation of a novel real-time stiffness detection strategy, without ad-hoc sensing, based on a Non-linear Logistic Regression (NLR) classifier. This exploits the minimum grasp information available from an under-sensorized and under-actuated myoelectric prosthetic hand, Hannes. The NLR algorithm takes as input motor-side current, encoder position, and reference position of the hand and provides as output a classification of the grasped object (no-object, rigid object, and soft object). This information is then transmitted to the user via vibratory feedback to close the loop between user control and prosthesis interaction. This implementation was validated through a user study conducted both on able bodied subjects and amputees. Results: The classifier achieved excellent performance in terms of F1Score (94.93%). Further, the able-bodied subjects and amputees were able to successfully detect the objects' stiffness with a F1Score of 94.08% and 86.41%, respectively, by using our proposed feedback strategy. This strategy allowed amputees to quickly recognize the objects' stiffness (response time of 2.82 s), indicating high intuitiveness, and it was overall appreciated as demonstrated by the questionnaire. Furthermore, an embodiment improvement was also obtained as highlighted by the proprioceptive drift toward the prosthesis (0.7 cm).

Benefits of the Cybathlon 2020 experience for a prosthetic hand user: a case study on the Hannes system.

BACKGROUND: Cybathlon championship aims at promoting the development of prosthetic and assistive devices capable to meet users' needs. This paper describes and analyses possible exploitation outcomes of our team's (REHAB TECH) experience into the Powered Arm Prosthesis Race of the Cybathlon 2020 Global Edition, with the novel prosthetic system Hannes. In detail, we present our analysis on a concurrent evaluation conducted to verify if the Cybathlon training and competition positively influenced pilot's performance and human-technology integration with Hannes, with respect to a non-runner Hannes user. METHODS: Two transradial amputees were recruited as pilots (Pilot 1 and Pilot 2) for the Cybathlon competition and were given the polyarticulated myoelectric prosthetic hand Hannes. Due to COVID-19 emergency, only Pilot 1 was trained for the race. However, both pilots kept Hannes for Home Use for seven weeks. Before this period, they both participated to the evaluation of functionality, embodiment, and user experience (UX) related to Hannes, which they repeated at the end of the Home Use and right after the competition. We analysed Pilot 1's training and race outcomes, as well as changes in the concurrent evaluation, and compared these results with Pilot 2's ones. RESULTS: The Cybathlon training gradually improved Pilot 1's performances, leading to the sixth place with a single error in task 5. In the parallel evaluation, both pilots had an overall improvement over time, whereas Pilot 2 experienced a deterioration of embodiment. In detail, Pilot 1, who followed the training and raced the Cybathlon, improved in greater way. CONCLUSION: Hannes demonstrated to be a valuable competitor and to perform grasps with human-like behaviors. The higher improvements of Pilot 1, who actively participated in the Cybathlon, in terms of functionality, embodiment and UX, may depend on his training and engagement in the effort of achieving a successful user-prosthesis interaction during the competition. Tasks based on Cybathlon's ones could improve the training phase of a prosthetic user, stimulating dexterity, prosthetic integration, and user perception towards the prosthesis. Likewise, timed races or competitions could facilitate and accelerate the learning phase, improving the efficiency and efficacy of the process.

A virtual reality-based mind-body approach to downregulate psychophysiological arousal in adolescent insomnia.

Objective: In this study, we describe the rationale, supported by preliminary data, for a novel, digital, immersive virtual reality (VR)-based mind-body approach, designed to reduce bedtime arousal in adolescents with insomnia. Methods: Fifty-two high-school students (16-20 years; 32 female) with (N = 18) and without (N = 34) DSM-5 insomnia symptoms engaged with 20 min of immersive VR-guided meditation and paced breathing (0.1 Hz) (intervention condition) and 20 min of quiet activity (control condition), right before bedtime, on two separate evenings. Results: The intervention resulted in acute autonomic and cortical modulation (p < 0.05), leading to reduced physiological arousal (↓heart rate, ↓cortisol) compared with the control condition, with similar effects in adolescents with and without insomnia. No significant changes were detected for cognitive arousal levels. During the intervention, all participants were able to achieve the targeted 0.1 Hz breathing rate, and the majority experienced no discomfort associated with the VR exposure. However, 30-40% of the participants experienced some trouble slowing down their breathing. Conclusions: The study provides supporting preliminary evidence for the mechanism behind a novel VR-based digital approach, designed to regulate psychophysiological arousal levels by acting on neurocognitive and autonomic pathways. Further studies (e.g. randomized clinical trials) are needed to evaluate the isolated and synergistic effects of its components (e.g. VR vs. VR + paced breathing), and its efficacy, acceptance, and feasibility in alleviating insomnia symptoms in adolescents.

User-Centered Design and Development of the Modular TWIN Lower Limb Exoskeleton.

For decades, powered exoskeletons have been considered for possible employment in rehabilitation and personal use. Yet, these devices are still far from addressing the needs of users. Here, we introduce TWIN, a novel modular lower limb exoskeleton for personal use of spinal-cord injury (SCI) subjects. This system was designed according to a set of user requirements (lightweight and autonomous portability, quick and autonomous donning and setup, stability when standing/walking, cost effectiveness, long battery life, comfort, safety) which emerged during participatory investigations that organically involved patients, engineers, designers, physiatrists, and physical therapists from two major rehabilitation centers in Italy. As a result of this user-centered process, TWIN's design is based on a variety of small mechatronic modules which are meant to be easily assembled and donned on or off by the user in full autonomy. This paper presents the development of TWIN, an exoskeleton for personal use of SCI users, and the application of user-centered design methods that are typically adopted in medical device industry, for its development. We can state that this approach revealed to be extremely effective and insightful to direct and continuously adapt design goals and activities toward the addressment of user needs, which led to the development of an exoskeleton with modular mechatronics and novel lateral quick release systems. Additionally, this work includes the preliminary assessment of this exoskeleton, which involved healthy volunteers and a complete SCI patient. Tests validated the mechatronics of TWIN and emphasized its high potential in terms of system usability for its intended use. These tests followed procedures defined in existing standards in usability engineering and were part of the formative evaluation of TWIN as a premise to the summative evaluation of its usability as medical device.

µRALP and Beyond: Micro-Technologies and Systems for Robot-Assisted Endoscopic Laser Microsurgery.

Laser microsurgery is the current gold standard surgical technique for the treatment of selected diseases in delicate organs such as the larynx. However, the operations require large surgical expertise and dexterity, and face significant limitations imposed by available technology, such as the requirement for direct line of sight to the surgical field, restricted access, and direct manual control of the surgical instruments. To change this status quo, the European project µRALP pioneered research towards a complete redesign of current laser microsurgery systems, focusing on the development of robotic micro-technologies to enable endoscopic operations. This has fostered awareness and interest in this field, which presents a unique set of needs, requirements and constraints, leading to research and technological developments beyond µRALP and its research consortium. This paper reviews the achievements and key contributions of such research, providing an overview of the current state of the art in robot-assisted endoscopic laser microsurgery. The primary target application considered is phonomicrosurgery, which is a representative use case involving highly challenging microsurgical techniques for the treatment of glottic diseases. The paper starts by presenting the motivations and rationale for endoscopic laser microsurgery, which leads to the introduction of robotics as an enabling technology for improved surgical field accessibility, visualization and management. Then, research goals, achievements, and current state of different technologies that can build-up to an effective robotic system for endoscopic laser microsurgery are presented. This includes research in micro-robotic laser steering, flexible robotic endoscopes, augmented imaging, assistive surgeon-robot interfaces, and cognitive surgical systems. Innovations in each of these areas are shown to provide sizable progress towards more precise, safer and higher quality endoscopic laser microsurgeries. Yet, major impact is really expected from the full integration of such individual contributions into a complete clinical surgical robotic system, as illustrated in the end of this paper with a description of preliminary cadaver trials conducted with the integrated µRALP system. Overall, the contribution of this paper lays in outlining the current state of the art and open challenges in the area of robot-assisted endoscopic laser microsurgery, which has important clinical applications even beyond laryngology.

Exploring the Embodiment of a Virtual Hand in a Spatially Augmented Respiratory Biofeedback Setting.

Enhancing the embodiment of artificial limbs-the individuals' feeling that a virtual or robotic limb is integrated in their own body scheme-is an impactful strategy for improving prosthetic technology acceptance and human-machine interaction. Most studies so far focused on visuo-tactile strategies to empower the embodiment processes. However, novel approaches could emerge from self-regulation techniques able to change the psychophysiological conditions of an individual. Accordingly, this pilot study investigates the effects of a self-regulated breathing exercise on the processes of body ownership underlying the embodiment of a virtual right hand within a Spatially Augmented Respiratory Biofeedback (SARB) setting. This investigation also aims at evaluating the feasibility of the breathing exercise enabled by a low-cost SARB implementation designed for upcoming remote studies (a need emerged during the COVID-19 pandemic). Twenty-two subjects without impairments, and two transradial prosthesis users for a preparatory test, were asked (in each condition of a within-group design) to maintain a normal (about 14 breaths/min) or slow (about 6 breaths/min) respiratory rate to keep a static virtual right hand "visible" on a screen. Meanwhile, a computer-generated sphere moved from left to right toward the virtual hand during each trial (1 min) of 16. If the participant's breathing rate was within the target (slow or normal) range, a visuo-tactile event was triggered by the sphere passing under the virtual hand (the subjects observed it shaking while they perceived a vibratory feedback generated by a smartphone). Our results-mainly based on questionnaire scores and proprioceptive drift-highlight that the slow breathing condition induced higher embodiment than the normal one. This preliminary study reveals the feasibility and potential of a novel psychophysiological training strategy to enhance the embodiment of artificial limbs. Future studies are needed to further investigate mechanisms, efficacy and generalizability of the SARB techniques in training a bionic limb embodiment.

Toward Emotion Recognition From Physiological Signals in the Wild: Approaching the Methodological Issues in Real-Life Data Collection.

Emotion, mood, and stress recognition (EMSR) has been studied in laboratory settings for decades. In particular, physiological signals are widely used to detect and classify affective states in lab conditions. However, physiological reactions to emotional stimuli have been found to differ in laboratory and natural settings. Thanks to recent technological progress (e.g., in wearables) the creation of EMSR systems for a large number of consumers during their everyday activities is increasingly possible. Therefore, datasets created in the wild are needed to insure the validity and the exploitability of EMSR models for real-life applications. In this paper, we initially present common techniques used in laboratory settings to induce emotions for the purpose of physiological dataset creation. Next, advantages and challenges of data collection in the wild are discussed. To assess the applicability of existing datasets to real-life applications, we propose a set of categories to guide and compare at a glance different methodologies used by researchers to collect such data. For this purpose, we also introduce a visual tool called Graphical Assessment of Real-life Application-Focused Emotional Dataset (GARAFED). In the last part of the paper, we apply the proposed tool to compare existing physiological datasets for EMSR in the wild and to show possible improvements and future directions of research. We wish for this paper and GARAFED to be used as guidelines for researchers and developers who aim at collecting affect-related data for real-life EMSR-based applications.

The GPS for surgery: A user-centered evaluation of a navigation system for laparoscopic surgery.

BACKGROUND: Unsafe surgical care has emerged as a significant public health concern, motivated by a high percentage of major complications happening during surgery, attributed to surgeons' skills and experience, and determined to be preventable. METHODS: This article presents APSurg, an Abdominal Positioning Surgical system designed to improve awareness and safety during laparoscopic surgery. The proposed system behaves like a GPS, offering an additional dynamic virtual reality view of the surgical field. RESULTS: This work presents an evaluation study in terms of accuracy, effectiveness, and usability. Tests were conducted performing a localization task on an abdomen phantom in a simulated scenario. Results show a navigation accuracy below 5 mm. The task execution time was reduced by a 15% and the performed incision dimension was reduced by a 46%, with respect to a standard setup. A custom questionnaire showed a significant positive impact in exploiting APSurg during the surgical task execution.

Reducing bedtime physiological arousal levels using immersive audio-visual respiratory bio-feedback: a pilot study in women with insomnia symptoms.

Hyperarousal is a critical component of insomnia, particularly at bedtime when individuals are trying to fall asleep. The current study evaluated the effect of a novel, acute behavioral experimental manipulation (combined immersive audio-visual relaxation and biofeedback) in reducing bedtime physiological hyperarousal in women with insomnia symptoms. After a clinical/adaptation polysomnographic (PSG) night, sixteen women with insomnia symptoms had two random-order PSG nights: immersive audio-visual respiratory bio-feedback across the falling asleep period (manipulation night), and no pre-sleep arousal manipulation (control night). While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation. HR continued to be lower during sleep, and participants had fewer awakenings and sleep stage transitions on the manipulation night relative to the control night (p < 0.05). The manipulation did not affect sleep onset latency or other PSG parameters. Overall, this novel behavioral approach targeting the falling asleep process emphasizes the importance of pre-sleep hyperarousal as a potential target for improving sleep and nocturnal autonomic function during sleep in insomnia.

Design and Study of a Next-Generation Computer-Assisted System for Transoral Laser Microsurgery.

OBJECTIVE: To present a new computer-assisted system for improved usability, intuitiveness, efficiency, and controllability in transoral laser microsurgery (TLM). STUDY DESIGN: Pilot technology feasibility study. SETTING: A dedicated room with a simulated TLM surgical setup: surgical microscope, surgical laser system, instruments, ex vivo pig larynxes, and computer-assisted system. SUBJECTS AND METHODS: The computer-assisted laser microsurgery (CALM) system consists of a novel motorized laser micromanipulator and a tablet- and stylus-based control interface. The system setup includes the Leica 2 surgical microscope and the DEKA HiScan Surgical laser system. The system was validated through a first-of-its-kind observational study with 57 international surgeons with varied experience in TLM. The subjects performed real surgical tasks on ex vivo pig larynxes in a simulated TLM scenario. The qualitative aspects were established with a newly devised questionnaire assessing the usability, efficiency, and suitability of the system. RESULTS: The surgeons evaluated the CALM system with an average score of 6.29 (out of 7) in ease of use and ease of learning, while an average score of 5.96 was assigned for controllability and safety. A score of 1.51 indicated reduced workload for the subjects. Of 57 subjects, 41 stated that the CALM system allows better surgical quality than the existing TLM systems. CONCLUSIONS: The CALM system augments the usability, controllability, and efficiency in TLM. It enhances the ergonomics and accuracy beyond the current state of the art, potentially improving the surgical safety and quality. The system offers the intraoperative automated scanning of customized long incisions achieving uniform resections at the surgical site.

Gaze-controlled Laser Pointer Platform for People with Severe Motor Impairments: Preliminary Test in Telepresence.

This paper describes the implementation and the preliminary evaluation of a novel interaction solution for people with severe motor impairments, and particularly for those affected by Amyotrophic Laterals Sclerosis (ALS) in Locked-In State (LIS): patients able to control only the ocular muscles. The proposed communication approach allows the person to control a laser beam and interact with the environment or interlocutors in an intuitive way by pointing at objects through their gaze. For this, a tip-tilt laser control device was developed and mounted on a small robot equipped with a high definition video camera. In addition, a gaze-tracking user interface was developed to control of both systems, i.e., laser and robot. This new platform was then preliminary assessed through trials with 14 subjects without disabilities, who performed tasks of robot navigation and pointing at objects along its path. User experience was evaluated with encouraging results, indicating the proposed technology has real potential to assist communication and interaction acts of people with ALS.

Haptic Feedback for Control and Active Constraints in Contactless Laser Surgery: Concept, Implementation, and Evaluation.

Haptics has proven to be highly beneficial in surgical robotics, bringing enhanced safety and precision by complementing the surgeon's visual channel. However, most of the research body in this context is dedicated to applications involving traditional "cold steel" surgical instruments. This paper proposes to bring the benefits of haptics to contactless surgeries, and presents a novel method to achieve this. The specific case of robot-assisted laser microsurgery is investigated. Here, a fictitious force feedback is created through stereoscopic visualization and 3D reconstruction, allowing the surgeon to sense the surgical area haptically while controlling a non-contact surgical laser. This is shown to significantly improve system usability and the accuracy of laser incisions, especially in applications involving several passes of the laser over the same incision line. Validation of the system is performed through two series of experiments involving both naive users and expert surgeons. The obtained results demonstrate that haptics can indeed be introduced in contactless laser surgery, allowing the exploitation of active constraints and guidance techniques that significantly enhance laser control accuracy both in static and dynamic environments. Furthermore, the proposed haptic technology shows good acceptance and high usability, indicating it has great potential to positively impact real surgeries.

Effects of galvanic skin response feedback on user experience in gaze-controlled gaming: A pilot study.

Eye-tracking (ET) is one of the most intuitive solutions for enabling people with severe motor impairments to control devices. Nevertheless, even such an effective assistive solution can detrimentally affect user experience during demanding tasks because of, for instance, the user's mental workload - using gaze-based controls for an extensive period of time can generate fatigue and cause frustration. Thus, it is necessary to design novel solutions for ET contexts able to improve the user experience, with particular attention to its aspects related to workload. In this paper, a pilot study evaluates the effects of a relaxation biofeedback system on the user experience in the context of a gaze-controlled task that is mentally and temporally demanding: ET-based gaming. Different aspects of the subjects' experience were investigated under two conditions of a gaze-controlled game. In the Biofeedback group (BF), the user triggered a command by means of voluntary relaxation, monitored through Galvanic Skin Response (GSR) and represented by visual feedback. In the No Biofeedback group (NBF), the same feedback was timed according to the average frequency of commands in BF. After the experiment, each subject filled out a user experience questionnaire. The results showed a general appreciation for BF, with a significant between-group difference in the perceived session time duration, with the latter being shorter for subjects in BF than for the ones in NBF. This result implies a lower mental workload for BF than for NBF subjects. Other results point toward a potential role of user's engagement in the improvement of user experience in BF. Such an effect highlights the value of relaxation biofeedback for improving the user experience in a demanding gaze-controlled task.

A hand-held robotic device for peripheral intravenous catheterization.

Intravenous catheterization is frequently required for numerous medical treatments. However, this process is characterized by a high failure rate, especially when performed on difficult patients such as newborns and infants. Very young patients have small veins, and that increases the chances of accidentally puncturing the catheterization needle directly through them. In this article, we present the design, development and experimental evaluation of a novel hand-held robotic device for improving the process of peripheral intravenous catheterization by facilitating the needle insertion procedure. To our knowledge, this design is the first hand-held robotic device for assisting in the catheterization insertion task. Compared to the other available technologies, it has several unique advantages such as being compact, low-cost and able to reliably detect venipuncture. The system is equipped with an electrical impedance sensor at the tip of the catheterization needle, which provides real-time measurements used to supervise and control the catheter insertion process. This allows the robotic system to precisely position the needle within the lumen of the target vein, leading to enhanced catheterization success rate. Experiments conducted to evaluate the device demonstrated that it is also effective to deskill the task. Naïve subjects achieved an average catheterization success rate of 88% on a 1.5 mm phantom vessel with the robotic device versus 12% with the traditional unassisted system. The results of this work prove the feasibility of a hand-held assistive robotic device for intravenous catheterization and show that such device has the potential to greatly improve the success rate of these difficult operations.