Occurrence and predictive factors of heterotopic ossification in severe acquired brain injured patients during rehabilitation stay: cross-sectional survey.

OBJECTIVES: To report occurrence and identify patient's features and risk factors of heterotopic ossifications in patients with severe acquired brain injury in intensive rehabilitation centres. DESIGN: Multicentre cross-sectional survey. SETTING: A total of 48 severe acquired brain injury rehabilitation institutes. PARTICIPANTS: Traumatic and non-traumatic severe brain-injured patients ( N = 689) in rehabilitation centres on 28 May 2016. MAIN OUTCOME MEASURE: Occurrence of heterotopic ossifications diagnosed by standard radiological and/or sonographic evaluation on the basis of clinical suspicion. RESULTS: Heterotopic ossification occurred around one or more joints in 94/689 patients (13.6%) with a significantly higher prevalence in young males. Occurrence did not significantly differ in relation to aetiology (16.3% traumatic, 19.2% anoxic, 11.7% vascular and 11.5% other). Prevalence was significantly higher in patients with diffuse (23.3%) rather than focal brain lesions (12.4%) or unspecified lesions (11.2%; chi-square = 7.81, df = 2, P = 0.020); longer duration of coma ( P = 0.0016) and ventilation support ( P = 0.0145); paroxysmal sympathetic hyperactivity (22.6% versus 11.6%; chi-square = 10.81, df = 1, P = 0.001); and spasticity (22.7% versus 10.1%; chi-square = 18.63, df = 1, P < 0.0001). A longer interval between acute brain injury and admission to rehabilitation centre was significantly associated with higher frequency of heterotopic ossifications. CONCLUSION: Occurrence of heterotopic ossifications is frequent in patients with severe traumatic and non-traumatic brain-injury in rehabilitation centres. Our study confirms male gender, young age, paroxysmal sympathetic hyperactivity, spasticity, longer duration of coma and ventilation and longer interval between brain injury onset and admission to rehabilitation centre as possible risk factors. Further studies are necessary to investigate the role of early appropriate rehabilitation pathways to reduce occurrence of heterotopic ossifications.

Lower urinary tract symptoms associated with neurological conditions: Observations on a clinical sample of outpatients neurorehabilitation service.

OBJECTIVES: The overall aims of this study were to investigate the lower urinary tract symptoms (LUTS) associated with neurological conditions and their prevalence and impact on a clinical sample of outpatients of a neurorehabilitation service. MATERIALS AND METHODS: We reviewed the files of 132 patients treated in our neurorehabilitation service from December 2012 to December 2013. Patients were divided into several subgroups based on the neurological diagnosis: Multiple Sclerosis (MS), other demyelinating diseases, Peripheral Neuropathy, neurovascular disorders (ND), neoplastic disease, traumatic brain injury (TBI), Parkinson and Parkinsonism, spinal cord injuries (SCI). Urinary status was based on medical evaluations of history of LUTS, type, degree, onset and duration of symptoms. We tried to analyze prevalence, kind of disorder, timing of presentation (if before or after the neurological onset) and eventual persistence of urological disorders (in the main group and in all subgroups). RESULTS: At the time of admission to our rehabilitation service, LUTS were observed in 14 out of 132 cases (11%). A high proportion of these outpatients (64.2%) presented bothersome urinary symptoms such as incontinence, frequency and urgency (storage LUTS). The most frequent symptom was urinary urge incontinence (42.8%). This symptom was found to be prevalent in the multiple sclerosis and neurovascular disorders. In 93% the urinary symptoms arose as a result of neurologic conditions and 78.5% did not present a complete recovery of urological symptoms in spite of improved self-reported functional activity limitations. None of these patients performed urological rehabilitation. CONCLUSIONS: Neurological disorders are a significant issue in rehabilitation services and it can lead to lower tract dysfunction, which causes LUTS. Storage symptoms are more common, especially urge incontinence. Current literature reports that a further optimization of the rehabilitation potential of neurologically ill patients is possible through an implementation of urological basic measures into the neurological treatment routine.

The Italian Society of Physical and Rehabilitation Medicine (SIMFER) recommendations for neck pain.

The paper represents the Italian Society of Physical " and Rehabilitation Medicine (SIMFER) recommendations to Neck Pain. We searched the principal scientific databases for papers concerning the main approaches to NP, including international guidelines, clinical trials of high methodological value and systematic reviews without any temporal limits. The recommendations were graded on the basis of the National Plan for Guidelines of the Italian Istituto Superiore di Sanità, which includes the level of evidence and strength of the recommendation. The principal sections of the recommendations deal with the Evaluation and Therapy for Neck Pain. The first describes the main evidence concerning the evaluation of patients with NP with or without limb involvement and/or headache: medical history, physical examination, neurological examination, laboratory tests, electrodiagnostics, diagnostic imaging and self-administered questionnaires. The second describes the best evidence synthesis concernig the therapy for Neck Pain: education, exercise, medical therapy, manual therapy, traction, physical therapy, acupuncture, orthoses, multimodal treatment, behavioural treatment.

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

BACKGROUND: Although stroke survivors can benefit from robotic gait rehabilitation, stationary robot-assisted gait training needs further investigation. In this paper, we investigated the efficacy of this approach (with an exoskeleton or an end-effector robot) in comparison to the conventional overground gait training in subacute stroke survivors. METHODS: In a multicenter controlled clinical trial, 89 subacute stroke survivors conducted twenty sessions of robot-assisted gait training (Robotic Group) or overground gait training (Control Group) in addition to the standard daily therapy. The robotic training was performed with an exoskeleton (RobotEXO-group) or an end-effector (RobotEND-group). Clinical outcomes were assessed before (T0) and after (T1) the treatment. The walking speed during the 10-Meter Walk Test (10 MWT) was the primary outcome of this study, and secondary outcomes were the 6-Minute Walk Test (6 MWT), Timed Up and Go test (TUG), and the modified Barthel Index (mBI). RESULTS: The main characteristics assessed in the Robotic and Control groups did not differ at baseline. A significant benefit was detected from the 10 MWT in the Robotic Group at the end of the study period (primary endpoint). A benefit was also observed from the following parameters: 6 MWT, TUG, and mBI. Moreover, patients belonging to the Robot Group outperformed the Control Group in gait speed, endurance, balance, and ADL. The RobotEND-group improved their walking speed more than the RobotEXO-group. CONCLUSION: The stationary robot-assisted training improved walking ability better than the conventional training in subacute stroke survivors. These results suggest that people with subacute stroke may benefit from Robot-Assisted training in potentiating gait speed and endurance. Our results also support that end-effector robots would be superior to exoskeleton robots for improving gait speed enhancement.

Balance Rehabilitation through Robot-Assisted Gait Training in Post-Stroke Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Balance impairment is a common disability in post-stroke survivors, leading to reduced mobility and increased fall risk. Robotic gait training (RAGT) is largely used, along with traditional training. There is, however, no strong evidence about RAGT superiority, especially on balance. This study aims to determine RAGT efficacy on balance of post-stroke survivors. METHODS: PubMed, Cochrane Library, and PeDRO databases were investigated. Randomized clinical trials evaluating RAGT efficacy on post-stroke survivor balance with Berg Balance Scale (BBS) or Timed Up and Go test (TUG) were searched. Meta-regression analyses were performed, considering weekly sessions, single-session duration, and robotic device used. RESULTS: A total of 18 trials have been included. BBS pre-post treatment mean difference is higher in RAGT-treated patients, with a pMD of 2.17 (95% CI 0.79; 3.55). TUG pre-post mean difference is in favor of RAGT, but not statistically, with a pMD of -0.62 (95%CI - 3.66; 2.43). Meta-regression analyses showed no relevant association, except for TUG and treatment duration (ß = -1.019, 95% CI - 1.827; -0.210, p-value = 0.0135). CONCLUSIONS: RAGT efficacy is equal to traditional therapy, while the combination of the two seems to lead to better outcomes than each individually performed. Robot-assisted balance training should be the focus of experimentation in the following years, given the great results in the first available trials. Given the massive heterogeneity of included patients, trials with more strict inclusion criteria (especially time from stroke) must be performed to finally define if and when RAGT is superior to traditional therapy.

Reference theories and future perspectives on robot-assisted rehabilitation in people with neurological conditions: A scoping review and recommendations from the Italian Consensus Conference on Robotics in Neurorehabilitation (CICERONE).

BACKGROUND: Robot-based treatments are developing in neurorehabilitation settings. Recently, the Italian National Health Systems recognized robot-based rehabilitation as a refundable service. Thus, the Italian neurorehabilitation community promoted a national consensus on this topic. OBJECTIVE: To conceptualize undisclosed perspectives for research and applications of robotics for neurorehabilitation, based on a qualitative synthesis of reference theoretical models. METHODS: A scoping review was carried out based on a specific question from the consensus Jury. A foreground search strategy was developed on theoretical models (context) of robot-based rehabilitation (exposure), in neurological patients (population). PubMed and EMBASE® databases were searched and studies on theoretical models of motor control, neurobiology of recovery, human-robot interaction and economic sustainability were included, while experimental studies not aimed to investigate theoretical frameworks, or considering prosthetics, were excluded. RESULTS: Overall, 3699 records were screened and finally 9 papers included according to inclusion and exclusion criteria. According to the population investigated, structured information on theoretical models and indications for future research was summarized in a synoptic table. CONCLUSION: The main indication from the Italian consensus on robotics in neurorehabilitation is the priority to design research studies aimed to investigate the role of robotic and electromechanical devices in promoting neuroplasticity.

Evidence-based improvement of gait in post-stroke patients following robot-assisted training: A systematic review.

BACKGROUND: The recovery of walking after stroke is a priority goal for recovering autonomy. In the last years robotic systems employed for Robotic Assisted Gait Training (RAGT) were developed. However, literature and clinical practice did not offer standardized RAGT protocol or pattern of evaluation scales. OBJECTIVE: This systematic review aimed to summarize the available evidence on the use of RAGT in post-stroke, following the CICERONE Consensus indications. METHODS: The literature search was conducted on PubMed, Cochrane Library and PEDro, including studies with the following criteria: 1) adult post-stroke survivors with gait disability in acute/subacute/chronic phase; 2) RAGT as intervention; 3) any comparators; 4) outcome regarding impairment, activity, and participation; 5) both primary studies and reviews. RESULTS: Sixty-one articles were selected. Data about characteristics of patients, level of disability, robotic devices used, RAGT protocols, outcome measures, and level of evidence were extracted. CONCLUSION: It is possible to identify robotic devices that are more suitable for specific phase disease and level of disability, but we identified significant variability in dose and protocols. RAGT as an add-on treatment seemed to be prevalent. Further studies are needed to investigate the outcomes achieved as a function of RAGT doses delivered.

Gait robot-assisted rehabilitation in persons with spinal cord injury: A scoping review.

BACKGROUND: Many robots are available for gait rehabilitation (BWSTRT and ORET) and their application in persons with SCI allowed an improvement of walking function. OBJECTIVE: The aim of the study is to compare the effects of different robotic exoskeletons gait training in persons with different SCI level and severity. METHODS: Sixty-two studies were included in this systematic review; the study quality was assessed according to GRADE and PEDro's scale. RESULTS: Quality assessment of included studies (n = 62) demonstrated a prevalence of evidence level 2; the quality of the studies was higher for BWSTRT (excellent and good) than for ORET (fair and good). Almost all persons recruited for BWSTRT had an incomplete SCI; both complete and incomplete SCI were recruited for ORET. The SCI lesion level in the persons recruited for BWSTRT are from cervical to sacral; mainly from thoracic to sacral for ORET; a high representation of AIS D lesion resulted both for BWSTRT (30%) and for ORET (45%). The walking performance, tested with 10MWT, 6MWT, TUG and WISCI, improved after exoskeleton training in persons with incomplete SCI lesions, when at least 20 sessions were applied. Persons with complete SCI lesions improved the dexterity in walking with exoskeleton, but did not recover independent walking function; symptoms such as spasticity, pain and cardiovascular endurance improved. CONCLUSION: Different exoskeletons are available for walking rehabilitation in persons with SCI. The choice about the kind of robotic gait training should be addressed on the basis of the lesion severity and the possible comorbidities.

Robot-assisted gait training in patients with Parkinson's disease: Implications for clinical practice. A systematic review.

BACKGROUND: Gait impairments are common disabling symptoms of Parkinson's disease (PD). Among the approaches for gait rehabilitation, interest in robotic devices has grown in recent years. However, the effectiveness compared to other interventions, the optimum amount of training, the type of device, and which patients might benefit most remains unclear. OBJECTIVE: To conduct a systematic review about the effects on gait of robot-assisted gait training (RAGT) in PD patients and to provide advice for clinical practice. METHODS: A search was performed on PubMed, Scopus, PEDro, Cochrane library, Web of science, and guideline databases, following PRISMA guidelines. We included English articles if they used a robotic system with details about the intervention, the parameters, and the outcome measures. We evaluated the level and quality of evidence. RESULTS: We included twenty papers out of 230 results: two systematic reviews, 9 randomized controlled trials, 4 uncontrolled studies, and 5 descriptive reports. Nine studies used an exoskeleton device and the remainders end-effector robots, with large variability in terms of subjects' disease-related disability. CONCLUSIONS: RAGT showed benefits on gait and no adverse events were recorded. However, it does not seem superior to other interventions, except in patients with more severe symptoms and advanced disease.

Effectiveness of robot-assisted arm therapy in stroke rehabilitation: An overview of systematic reviews.

BACKGROUND: Robot-assisted arm therapy (RAT) has been used mainly in stroke rehabilitation in the last 20 years with rising expectations and growing evidence summarized in systematic reviews (SRs). OBJECTIVE: The aim of this study is to provide an overview of SRs about the effectiveness, within the ICF domains, and safety of RAT in the rehabilitation of adult with stroke compared to other treatments. METHODS: The search strategy was conducted using search strings adapted explicitly for each database. A screening base on title and abstract was realized to find all the potentially relevant studies. The methodological quality of the included SRs was assessed using AMSTAR-2. A pre-determined standardized form was used to realize the data extraction. RESULTS: 18 SRs were included in this overview. Generally, positive effects from the RAT were found for motor function and muscle strength, whereas there is no agreement for muscle tone effects. No effect was found for pain, and only a SR reported the positive impact of RAT in daily living activity. CONCLUSION: RAT can be considered a valuable option to increase motor function and muscle strength after stroke. However, the poor quality of most of the included SRs could limit the certainty around the results.

Robot-assisted rehabilitation for children with neurological disabilities: Results of the Italian consensus conference CICERONE.

BACKGROUND: The use of robotic technologies in pediatric rehabilitation has seen a large increase, but with a lack of a comprehensive framework about their effectiveness. OBJECTIVE: An Italian Consensus Conference has been promoted to develop recommendations on these technologies: definitions and classification criteria of devices, indications and limits of their use in neurological diseases, theoretical models, ethical and legal implications. In this paper, we present the results for the pediatric age. METHODS: A systematic search on Cochrane Library, PEDro and PubMed was performed. Papers published up to March 1st, 2020, in English, were included and analyzed using the methodology of the Centre for Evidence-Based Medicine in Oxford, AMSTAR2 and PEDro scales for systematic reviews and RCT, respectively. RESULTS: Some positives aspects emerged in the area of gait: an increased number of children reaching the stance, an improvement in walking distance, speed and endurance. Critical aspects include the heterogeneity of the studied cases, measurements and training protocols. CONCLUSION: Many studies demonstrate the benefits of robotic training in developmental age. However, it is necessary to increase the number of trials to achieve greater homogeneity between protocols and to confirm the effectiveness of pediatric robotic rehabilitation.

Effects of robotic upper limb treatment after stroke on cognitive patterns: A systematic review.

BACKGROUND: Robotic therapy (RT) has been internationally recognized for the motor rehabilitation of the upper limb. Although it seems that RT can stimulate and promote neuroplasticity, the effectiveness of robotics in restoring cognitive deficits has been considered only in a few recent studies. OBJECTIVE: To verify whether, in the current state of the literature, cognitive measures are used as inclusion or exclusion criteria and/or outcomes measures in robotic upper limb rehabilitation in stroke patients. METHODS: The systematic review was conducted according to PRISMA guidelines. Studies eligible were identified through PubMed/MEDLINE and Web of Science from inception to March 2021. RESULTS: Eighty-one studies were considered in this systematic review. Seventy-three studies have at least a cognitive inclusion or exclusion criteria, while only seven studies assessed cognitive outcomes. CONCLUSION: Despite the high presence of cognitive instruments used for inclusion/exclusion criteria their heterogeneity did not allow the identification of a guideline for the evaluation of patients in different stroke stages. Therefore, although the heterogeneity and the low percentage of studies that included cognitive outcomes, seemed that the latter were positively influenced by RT in post-stroke rehabilitation. Future larger RCTs are needed to outline which cognitive scales are most suitable and their cut-off, as well as what cognitive outcome measures to use in the various stages of post-stroke rehabilitation.

Acute medical complications in patients admitted to a stroke unit and safe transfer to rehabilitation.

Acute medical complications often prevent patients with stroke from being transferred from stroke units to rehabilitation units, prolonging the occupation of hospital beds and delaying the start of intensive rehabilitation. This study defined incidence, timing, duration and risk factors of these complications during the acute phase of stroke. A retrospective case note review was made of hospital admissions of patients with stroke not associated with other disabling conditions, admitted to a stroke unit over 12 months and requiring rehabilitation for gait impairment. In this cohort, a search was made of hypertension, oxygen de-saturation, fever, and cardiac and pulmonary symptoms requiring medical intervention. Included were 135 patients. Hypertension was the most common complication (16.3%), followed by heart disease (14.8%), oxygen de-saturation (7.4%), fever (6.7%) and pulmonary disease (5.2%). Heart disease was the earliest and shortest complication. Most complications occurred during the first week. Except for hypertension, all complications resolved within 2 weeks.

What is the impact of robotic rehabilitation on balance and gait outcomes in people with multiple sclerosis? A systematic review of randomized control trials.

INTRODUCTION: In recent years, robot-assisted gait training (RAGT) has been proposed as therapy for balance and gait dysfunctions in people with multiple sclerosis (PwMS). Through this systematic review, we aimed to discuss the impact of RAGT on balance and gait outcomes. Furthermore, characteristics of the training in terms of robots used, participants characteristics, protocols and combined therapeutic approaches have been described. EVIDENCE ACQUISITION: As part of the Italian Consensus on robotic rehabilitation "CICERONE" a systematic search was provided in PubMed, the Cochrane Library and PEDro to identify relevant studies published before December 2019. Only randomized control trials (RCT) involving RAGT for PwMS were included. PEDro scale was used to assess the risk of bias and the Oxford Center for Evidence-Based Medicine (OCEBM) was used to assess level of evidence of included studies. EVIDENCE SYNTHESIS: The search on databases resulted in 336 records and, finally, 12 studies were included. RAGT was provided with Exoskeleton in ten studies (6-40 session, 2-5 per week) and with end-effector in two studies (12 sessions, 2-3 per week) with large variability in terms of participants' disability. All the exoskeletons were combined with bodyweight support treadmill and movement assistance varied from 0% to 100% depending on participants' disability, two studies combined exoskeleton with virtual reality. The end-effector speed ranged between 1.3 and 1.8 km/h, with bodyweight support starting from 50% and progressively reduced. In seven out of twelve studies RAGT was provided in a multimodal rehabilitation program or in combination with standard physical therapy. There is level 2 evidence that RAGT has positive impact in PwMS, reaching the minimally clinically importance difference in Berg Balance Scale, six-minute walking test and gait speed. CONCLUSIONS: In available RCT, RAGT is mostly provided with exoskeleton devices and improves balance and gait outcomes in a clinically meaningful way. Considering several advantages in terms of safety, motor assistance and intensity of training provided, RAGT should be promoted for PwMS with severe disability in a multimodal rehabilitation context as an opportunity to maximize recovery.

State of the art and challenges for the classification of studies on electromechanical and robotic devices in neurorehabilitation: a scoping review.

INTRODUCTION: The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyze the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems. EVIDENCE ACQUISITION: Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated. EVIDENCE SYNTHESIS: Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults). CONCLUSIONS: The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.

Robot-Assisted Training for Upper Limb in Stroke (ROBOTAS): An Observational, Multicenter Study to Identify Determinants of Efficacy.

BACKGROUND: The loss of arm function is a common and disabling outcome after stroke. Robot-assisted upper limb (UL) training may improve outcomes. The aim of this study was to explore the effect of robot-assisted training using end-effector and exoskeleton robots on UL function following a stroke in real-life clinical practice. METHODS: A total of 105 patients affected by a first-ever supratentorial stroke were enrolled in 18 neurorehabilitation centers and treated with electromechanically assisted arm training as an add-on to conventional therapy. Both interventions provided either an exoskeleton or an end-effector device (as per clinical practice) and consisted of 20 sessions (3/5 times per week; 6-8 weeks). Patients were assessed by validated UL scales at baseline (T0), post-treatment (T1), and at three-month follow-up (T2). The primary outcome was the Fugl-Meyer Assessment for the upper extremity (FMA-UE). RESULTS: FMA-UE improved at T1 by 6 points on average in the end-effector group and 11 points on average in the exoskeleton group (p < 0.0001). Exoskeletons were more effective in the subacute phase, whereas the end-effectors were more effective in the chronic phase (p < 0.0001). CONCLUSIONS: robot-assisted training might help improve UL function in stroke patients as an add-on treatment in both subacute and chronic stages. Pragmatic and highmethodological studies are needed to confirm the showed effectiveness of the exoskeleton and end-effector devices.

Systematic review of guidelines to identify recommendations for upper limb robotic rehabilitation after stroke.

INTRODUCTION: Upper limb motor impairment is one of the most frequent stroke consequences. Robot therapy may represent a valid option for upper limb stroke rehabilitation, but there are still gaps between research evidence and their use in clinical practice. The aim of this study was to determine the quality, scope, and consistency of guidelines clinical practice recommendations for upper limb robotic rehabilitation in stroke populations. EVIDENCE ACQUISITION: We searched for guideline recommendations on stroke published between January 1st, 2010 and January 1st, 2020. Only the most recent guidelines for writing group were selected. Electronic databases (N.=4), guideline repertories and professional rehabilitation networks (N.=12) were searched. We systematically reviewed and assessed guidelines containing recommendation statements about upper limb robotic rehabilitation for adults with stroke (PROSPERO registration number: CRD42020173386). EVIDENCE SYNTHESIS: Four independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and textual syntheses were used to appraise and compare recommendations. From 1324 papers that were screened, eight eligible guidelines were identified from six different regions/countries. Half of the included guidelines focused on stroke management, the other half on stroke rehabilitation. Rehabilitation assisted by robotic devices is generally recommended to improve upper limb motor function and strength. The exact characteristics of patients who could benefit from this treatment as well as the correct timing to use it are not known. CONCLUSIONS: This systematic review has identified many opportunities to modernize and otherwise improve stroke patients' upper limb robotic therapy. Rehabilitation assisted by robot or electromechanical devices for stroke needs to be improved in clinical practice guidelines in particular in terms of applicability.

What does evidence tell us about the use of gait robotic devices in patients with multiple sclerosis? A comprehensive systematic review on functional outcomes and clinical recommendations.

INTRODUCTION: There is growing evidence on the efficacy of gait robotic rehabilitation in patients with multiple sclerosis (MS), but most of the studies have focused on gait parameters. Moreover, clear indications on the clinical use of robotics still lack. As part of the CICERONE Italian Consensus on Robotic Rehabilitation, the aim of this systematic review was to investigate the existing evidence concerning the role of lower limb robotic rehabilitation in improving functional recovery in patients with MS. EVIDENCE ACQUISITION: We searched for and systematically reviewed evidence-based studies on gait robotic rehabilitation in MS, between January 1st, 2010 and December 31st, 2020, in the following databases: Cochrane Library, PEDro, PubMed and Google Scholar. The study quality was assessed by the 16-item assessment of multiple systematic reviews 2 (AMSTAR 2) and the 10-item PEDro scale for the other research studies. EVIDENCE SYNTHESIS: After an accurate screening, only 17 papers were included in the review, and most of them (13 RCT) had a level II evidence. Most of the studies used the Lokomat as a grounded robotic device, two investigated the efficacy of end-effectors and two powered exoskeletons. Generally speaking, robotic treatment has beneficial effects on gait speed, endurance and balance with comparable outcomes to those of conventional treatments. However, in more severe patients (EDSS >6), robotics leads to better functional outcomes. Notably, after gait training with robotics (especially when coupled to virtual reality) MS patients also reach better non-motor outcomes, including spasticity, fatigue, pain, psychological well-being and quality of life. Unfortunately, no clinical indications emerge on the treatment protocols. CONCLUSIONS: The present comprehensive systematic review highlights the potential beneficial role on functional outcomes of the lower limb robotic devices in people with MS. Future studies are warranted to evaluate the role of robotics not only for walking and balance outcomes, but also for other gait-training-related benefits, to identify appropriate outcome measures related to a specific subgroup of MS subjects' disease severity.

Robot-assisted arm therapy in neurological health conditions: rationale and methodology for the evidence synthesis in the CICERONE Italian Consensus Conference.

BACKGROUND: Robot-assisted Arm Therapy (RAT) has been increasingly applied in the last years for promoting functional recovery in patients with disabilities related to neurological health conditions. Evidence of a knowledge-to-action gap for applying robot-assisted technologies in the rehabilitation of patients with neurological health conditions and the difficulty to apply and tailor the knowledge to the local contexts solicited the need for a national consensus conference on these interventions. AIM: The aim of this paper was to explain the methodology used by the working group dedicated to synthesizing evidence on the effectiveness of RAT in neurological health conditions in the context of the CICERONE Italian Consensus Conference. DESIGN: The methodological approach of the working group. SETTING: All rehabilitation settings. POPULATION: Patients with disability following a neurological health condition. METHODS: Following the indications proposed by the Methodological Manual published by the Italian National Institute of Health, a Promoting Committee and a Technical Scientific Committee have been set up. Six working groups (WGs) have been composed to collect evidence on different questions, among which WG2.2 was focused on the effectiveness of RAT in neurological health conditions. RESULTS: WG2.2 started its work defining the specific research questions. It was decided to adopt the ICF as the reference framework for the reporting of all outcomes. Literature search, data extraction and qualitative assessment, evidence analysis and synthesis have been performed. CONCLUSIONS: This paper summarized the methodological approaches used by the WG2.2 of the CICERONE Italian Consensus Conference to define the effectiveness of RAT in the management of patients with neurological health conditions. CLINICAL REHABILITATION IMPACT: WG2.2 synthesis might help clinicians, researchers, and all rehabilitation stakeholders to address the use of RAT in the Individualized Rehabilitation Plan, to guide the allocation of resources and define clinical protocols and indications for the management of patients with different neurological health conditions.

Upper Limb Robotic Rehabilitation for Patients with Cervical Spinal Cord Injury: A Comprehensive Review.

The upper extremities limitation represents one of the essential functional impairments in patients with cervical spinal cord injury. Electromechanics assisted devices and robots are increasingly used in neurorehabilitation to help functional improvement in patients with neurological diseases. This review aimed to systematically report the evidence-based, state-of-art on clinical applications and robotic-assisted arm training (RAT) in motor and functional recovery in subjects affected by cervical spinal cord injury. The present study has been carried out within the framework of the Italian Consensus Conference on "Rehabilitation assisted by robotic and electromechanical devices for persons with disability of neurological origin" (CICERONE). PubMed/MEDLINE, Cochrane Library, and Physiotherapy Evidence Database (PEDro) databases were systematically searched from inception to September 2021. The 10-item PEDro scale assessed the study quality for the RCT and the AMSTAR-2 for the systematic review. Two different authors rated the studies included in this review. If consensus was not achieved after discussion, a third reviewer was interrogated. The five-item Oxford CEBM scale was used to rate the level of evidence. A total of 11 studies were included. The selected studies were: two systematic reviews, two RCTs, one parallel-group controlled trial, one longitudinal intervention study and five case series. One RCT was scored as a high-quality study, while the systematic review was of low quality. RAT was reported as feasible and safe. Initial positive effects of RAT were found for arm function and quality of movement in addition to conventional therapy. The high clinical heterogeneity of treatment programs and the variety of robot devices could severely affect the generalizability of the study results. Therefore, future studies are warranted to standardize the type of intervention and evaluate the role of robotic-assisted training in subjects affected by cervical spinal cord injury.