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Background:. Multiple sclerosis (MS) is a chronic disease that primarily affects young adults and causes disability by impairing the central nervous system. Gait impairments are common in people with MS (pwMS), and lower limb orthoses are often used to improve stability and mobility. However, compliance with orthotic devices can vary among individuals due to issues related to the appropriate prescription and lack of acceptability. Objective:. In this observational, cross-sectional study, we aimed to explore the experience of wearing a passive hip flexion device in a cohort of pwMS. Methods:. We included men and women >18 years old affected by MS (Expanded Disability Status Scale >4) who have been using a passive hip flexion device (ExoBand, Moveo srl) since 2020 for at least 15 days. The participants completed a phone survey that collected demographic, anthropometric, and clinical data, their perceptions of the device’s impact using the Psychosocial Impact of Assistive Devices (PIADS) questionnaire, and a qualitative part with an open-ended question. Results:. A total of 41 patients completed the survey. The participants experienced improvements in all 3 areas of the PIADS questionnaire since using the ExoBand (P

Abstract Background Following a stroke, patients may suffer from alterations in the perception of their own body due to an acquired deficit in body representations. While such changes may impact their quality of life as well as recovery, they are not systematically assessed in clinical practice. This study aims at providing a better understanding of the rate, evolution, and impact on recovery of upper limb (UL) body perceptions (BPs) alterations following stroke. In addition, we will investigate associations among BPs alterations items, their associations with the sensorimotor functions, UL activity, damages in brain structure and connectivity. Methods We developed a new tool named ALPQ (for Affected Limb Perception Questionnaire) to address the present study objectives. It assesses subjective alterations in the perception of the affected UL following stroke, by measuring several dimensions, namely: anosognosia for hemiplegia, anosodiaphoria for hemiplegia, hemiasomatognosia, somatoparaphrenia, personification of the affected limb, illusion of modification of physical characteristics (temperature, weight, length), illusory movements, super- or undernumerary limb, UL disconnection, misoplegia, and involuntary movement. This study combines a cross-sectional and longitudinal design. The completed data sample will include a minimum of 60 acute and 100 sub-acute stroke patients. When possible, patients are followed up to the chronic stage. Complementary evaluations are administered to assess patients’ sensorimotor and cognitive functions as well as UL activity, and brain lesions will be analysed. Discussion This study will provide a better understanding of BPs alterations following stroke: their rate and evolution, as well as their associations with sensorimotor deficit, cognitive profile and UL activity, brain lesions and recovery. Ultimately, the results could support the personalization of rehabilitation strategy according to patients’ UL perception to maximize their recovery. Study registration The protocol for this study has been pre-registered on the Open Science Framework on July the 7th, 2021: https://osf.io/p6v7f .

Spasticity management should be provided within the context of a comprehensive person-centered rehabilitation program. Furthermore, active goal setting for specific spasticity interventions is also important, with a well-established “more is better” approach. It is critical to consider adjunctive therapy and multimodal approaches if patients are not attaining their treatment goals. Often used interchangeably, there may be confusion between the terms adjunctive and multimodal therapy. Yet it is imperative to understand the differences between these approaches to achieve treatment goals in spasticity management. Addition of a secondary pharmacologic or non-pharmacologic treatment to optimize the efficacy of the initial modality, such as adding electrical stimulation or casting to BoNT-A, is considered an adjunctive therapy. Adjunctive therapy is time-specific and requires the added therapy be initiated within a specific period to enhance the primary treatment; usually within 2 weeks. Multimodal therapy is an integrated, patient-centric program of pharmacologic and non-pharmacologic strategies utilized in a concurrent/integrated or sequential manner to enhance the overall treatment effect across a variety of spasticity-associated impairments (e.g., neural and non-neural components). Moreover, within a multimodal approach, adjunctive therapy can be used to help enhance the treatment effect of one specific modality. The objectives of this paper are to clarify the differences between adjunctive and multimodal therapies, provide a brief evidence-based review of such approaches, and highlight clinical insights on selecting multimodal and adjunctive therapies in spasticity management.

In the context of neurorehabilitation, there have been rapid and continuous improvements in sensors-based clinical tools to quantify limb performance. As a result of the increasing integration of technologies in the assessment procedure, the need to integrate evidence-based medicine with benchmarking has emerged in the scientific community. In this work, we present the experimental validation of our previously proposed benchmarking scheme for upper limb capabilities in terms of repeatability, reproducibility, and clinical meaningfulness. We performed a prospective multicenter study on neurologically intact young and elderly subjects and post-stroke patients while recording kinematics and electromyography. 60 subjects (30 young healthy, 15 elderly healthy, and 15 post-stroke) completed the benchmarking protocol. The framework was repeatable among different assessors and instrumentation. Age did not significantly impact the performance indicators of the scheme for healthy subjects. In post-stroke subjects, the movements presented decreased smoothness and speed, the movement amplitude was reduced, and the muscular activation showed lower power and lower intra-limb coordination. We revised the original framework reducing it to three motor skills, and we extracted 14 significant performance indicators with a good correlation with the ARAT clinical scale. The applicability of the scheme is wide, and it may be considered a valuable tool for upper limb functional evaluation in the clinical routine.

Botulinum toxin type-A (BoNT-A) has emerged as a key therapeutic agent for the management of spasticity. This paper presents a comprehensive bibliometric and visual analysis of research concerning BoNT-A treatment of spasticity to elucidate current trends and future directions in this research area. A search was conducted in the Web of Science database for articles focused on the use of BoNT-A in spasticity published between 2000 and 2022. We extracted various metrics, including counts of publications and contributions from different countries, institutions, authors, and journals. Analytical methods in CiteSpace were employed for the examination of co-citations, collaborations, and the co-occurrence of keywords. Our search yielded 1489 publications. Analysis revealed a consistent annual increase in research output. The United States, United Kingdom, and Italy were the leading contributors. The top institution in this research was Assistance Publique Hopitaux, Paris. The journal containing the highest number of relevant publications was Toxins. Key frequently occurring keywords were ‘stroke’, ‘cerebral palsy’, ‘adult spasticity’, and ‘upper extremity’. This study identified 12 clusters of keywords and 15 clusters of co-cited references, indicating the main focus areas and emerging themes in this field. This study comprehensively analyzed and summarized trends in BoNT-A research in the field of spasticity over the past 22 years.

Abstract The Tropical Western-Central Indian Ocean (WCIO) precipitation anomalies play an important role in modulating the anomalous climate conditions in the North Atlantic and European (NAE) region during the early boreal winter (November–December; ND) season. In this study, we analyzed the forcing mechanism and predictability for the early winter tropical WCIO precipitation anomalies and its teleconnections to the North Atlantic region. The two main forcing mechanisms emerging are the autumn Indian Ocean Dipole (IOD) and a direct atmospheric teleconnection from El Niño-Southern Oscillation (ENSO). Since the autumn IOD is partially forced by ENSO, their independent contributions are also investigated. We found the IOD dominates over the ENSO contribution. The ECMWF-SEAS5 seasonal re-forecast reproduces these forcing mechanisms well and shows a substantial prediction skill for early winter WCIO precipitation. Moreover, the North Atlantic response to the positive WCIO phase projects spatially onto the positive North Atlantic Oscillation (NAO) phase through atmospheric teleconnections and leads to warming in central and western Europe. This teleconnection is reproduced by ECMWF-SEAS5, but with weaker amplitude. Moreover, a significant prediction skill for the NAO as well as for the central and western European temperature anomalies is noted, which is mostly induced by the Indian Ocean precipitation anomalies during early winter.

Objective: Human figure drawings are widely used in clinical practice as a qualitative indication of Body Representations (BRs) alterations in stroke patients. The objective of this study is to present and validate the use of a new app called QDraw for the quantitative analysis of drawings and to investigate whether this analysis can reveal distortions of BRs in chronic stroke patients. Results: QDraw has proven to generate reliable data as compared to manual scoring and in terms of inter-rater reliability, as shown by the high correlation coefficients. Moreover, human figure drawings from chronic stroke patients demonstrated a distortion of upper limb perception, as shown by a significantly higher arm length asymmetry compared to legs, whereas no difference was found in healthy controls. Conclusions: The present study supports the use of quantitative, digital methods (the QDraw app) to analyze human figure drawings as a tool to evaluate BRs distortions in stroke patients.

Abstract This study was designed to investigate the feasibility and the potential effects on walking performance of a short gait training with a novel impairment-specific hip assistance (iHA) through a bilateral active pelvis orthosis (APO) in patients with acquired brain injury (ABI). Fourteen subjects capable of independent gait and exhibiting mild-to-moderate gait deficits, due to an ABI, were enrolled. Subjects presenting deficit in hip flexion and/or extension were included and divided into two groups based on the presence (group A, n = 6) or absence (group B, n = 8) of knee hyperextension during stance phase of walking. Two iHA-based profiles were developed for the groups. The protocol included two overground gait training sessions using APO, and two evaluation sessions, pre and post training. Primary outcomes were pre vs. post-training walking distance and steady-state speed in the 6-min walking test. Secondary outcomes were self-selected speed, joint kinematics and kinetics, gait symmetry and forward propulsion, assessed through 3D gait analysis. Following the training, study participants significantly increased the walked distance and average steady-state speed in the 6-min walking tests, both when walking with and without the APO. The increased walked distance surpassed the minimal clinically important difference for groups A and B, (respectively, 42 and 57 m > 34 m). In group A, five out of six subjects had decreased knee hyperextension at the post-training session (on average the peak of the knee extension angle was reduced by 36%). Knee flexion during swing phase increased, by 16% and 31%, for A and B groups respectively. Two-day gait training with APO providing iHA was effective and safe in improving walking performance and knee kinematics in ABI survivors. These preliminary findings suggest that this strategy may be viable for subject-specific post-ABI gait rehabilitation.

Abstract Background In neurorehabilitation, we are witnessing a growing awareness of the importance of standardized quantitative assessment of limb functions. Detailed assessments of the sensorimotor deficits following neurological disorders are crucial. So far, this assessment has relied mainly on clinical scales, which showed several drawbacks. Different technologies could provide more objective and repeatable measurements. However, the current literature lacks practical guidelines for this purpose. Nowadays, the integration of available metrics, protocols, and algorithms into one harmonized benchmarking ecosystem for clinical and research practice is necessary. Methods This work presents a benchmarking framework for upper limb capacity. The scheme resulted from a multidisciplinary and iterative discussion among several partners with previous experience in benchmarking methodology, robotics, and clinical neurorehabilitation. We merged previous knowledge in benchmarking methodologies for human locomotion and direct clinical and engineering experience in upper limb rehabilitation. The scheme was designed to enable an instrumented evaluation of arm capacity and to assess the effectiveness of rehabilitative interventions with high reproducibility and resolution. It includes four elements: (1) a taxonomy for motor skills and abilities, (2) a list of performance indicators, (3) a list of required sensor modalities, and (4) a set of reproducible experimental protocols. Results We proposed six motor primitives as building blocks of most upper-limb daily-life activities and combined them into a set of functional motor skills. We identified the main aspects to be considered during clinical evaluation, and grouped them into ten motor abilities categories. For each ability, we proposed a set of performance indicators to quantify the proposed ability on a quantitative and high-resolution scale. Finally, we defined the procedures to be followed to perform the benchmarking assessment in a reproducible and reliable way, including the definition of the kinematic models and the target muscles. Conclusions This work represents the first unified scheme for the benchmarking of upper limb capacity. To reach a consensus, this scheme should be validated with real experiments across clinical conditions and motor skills. This validation phase is expected to create a shared database of human performance, necessary to have realistic comparisons of treatments and drive the development of new personalized technologies.

Ischemic stroke (IS) can be caused by perturbations of the gut–brain axis. An imbalance in the gut microbiota (GM), or dysbiosis, may be linked to several IS risk factors and can influence the brain through the production of different metabolites, such as short-chain fatty acids (SCFAs), indole and derivatives. This study examines ecological changes in the GM and its metabolic activities after stroke. Fecal samples of 10 IS patients were compared to 21 healthy controls (CTRLs). GM ecological profiles were generated via 16S rRNA taxonomy as functional profiles using metabolomics analysis performed with a gas chromatograph coupled to a mass spectrometer (GC-MS). Additionally fecal zonulin, a marker of gut permeability, was measured using an enzyme-linked immuno assay (ELISA). Data were analyzed using univariate and multivariate statistical analyses and correlated with clinical features and biochemical variables using correlation and nonparametric tests. Metabolomic analyses, carried out on a subject subgroup, revealed a high concentration of fecal metabolites, such as SCFAs, in the GM of IS patients, which was corroborated by the enrichment of SCFA-producing bacterial genera such as Bacteroides, Christensellaceae, Alistipes and Akkermansia. Conversely, indole and 3-methyl indole (skatole) decreased compared to a subset of six CTRLs. This study illustrates how IS might affect the gut microbial milieu and may suggest potential microbial and metabolic biomarkers of IS. Expanded populations of Akkermansia and enrichment of acetic acid could be considered potential disease phenotype signatures.

A strong correlation has been reported between patient-reported quality of life (QoL) and the investigator-rated Disability Assessment Scale (DAS) in patients with spasticity. The current analysis evaluates the effect of incobotulinumtoxinA on QoL-related outcomes (limb position abnormality, as well as dressing- and hygiene-related disability, measured with the DAS) in adults with upper limb spasticity, using pooled data from six studies. Separate analyses for each DAS domain were performed using data from patients with disabilities for that domain (DAS score ≥1). Results showed that a significantly greater proportion of incobotulinumtoxinA-treated compared with placebo-treated patients achieved a ≥1-point reduction from baseline in each of the DAS domains (improvement) 4 weeks after the first injection. The benefits of incobotulinumtoxinA were observed regardless of the baseline severity of DAS impairment and of the time elapsed since stroke. The effects of incobotulinumtoxinA 4 weeks after injection were maintained or enhanced over multiple injection cycles for all three DAS domains, supporting the use of repeated injection cycles to provide sustained QoL benefit. IncobotulinumtoxinA represents an important treatment option to achieve better QoL-related outcomes for patients with upper limb spasticity, irrespective of the duration of their condition.

The objective of this article is to introduce the GO-FAST Tool (developed by the Toxnet group) to clinicians working in the field of neurological rehabilitation, specifically post-stroke spasticity management. The concepts utilized in the Tool and described in this article can be broadly grouped into five topics: the principles of patient-centred goal-setting; an algorithm for setting SMART (specific, measurable, attainable, realistic, and timed) treatment goals; goal-related target muscles and botulinum toxin type A dose determinants; goal attainment follow-up, scoring, and interpretation; and the multimodal approach to spasticity management. The Tool can enhance clinical practice by providing guided assistance with goal-setting and target muscle selection for botulinum toxin type A treatment. It also provides support with the follow-up evaluation of goal attainment and calculation of treatment success. The Tool is designed to be used by clinicians with varying levels of expertise in the field of neurological rehabilitation and post-stroke spasticity management, from those who are new to the field to those with many years of experience. A case study is presented in the Results Section of the article to illustrate the utility of the Tool in setting SMART treatment goals in the management of patients with post-stroke spasticity.

This module discusses the pathophysiology of spasticity and the lesions underlying the condition. It considers the clinical presentation of spasticity and outlines the relevant clinical history that should be documented. The positive and negative signs of spasticity are explained. Clinical presentations of spasticity are discussed, and an illustrated table of spastic limb postures details how the muscles involved in each individual's condition may be identified. The main systems for assessing the severity of the condition, the Ashworth Scale, the modified Ashworth scale, and the Tardieu Scale, are explained. The likelihood of spasticity developing following a stroke and the probable long-term outcomes are considered. The value of involving patients in their own treatment regimens, by defining and setting goals, using the SMARTER system is explained, and the need to continually assess and refine treatment with time as the condition progresses is also discussed.

Abstract Background Although Osteogenesis Imperfecta (OI) affects the connective tissue causing extremely brittle bones with consequent skeletal deformities, it is important to go beyond bones. Indeed, the quality of life in OI does not only depend on bones status, as OI might affect also other important functions. We have therefore implemented a multidisciplinary study to assess lung function, breathing pattern, sleep quality and nutritional status in 27 adult OI type III and IV patients (median age: 34.6 years; 19 women; 14 type III). Results According to nocturnal oxygen desaturation, two groups were identified: 13 patients with (OI_OSA, incidence: 48.2%) and 14 without (no_OSA) obstructive sleep apnea. The former was characterized by higher spinal and ribcage deformity, by more restrictive lung function, by paradoxical thoracic breathing in supine position, by rapid and shallow breathing, by higher body mass index, by longer neck and waist circumferences; by higher abdominal volume and by greater percentage of body fat mass, particularly localized in the trunk. The best predictor of OI_OSA was the negative value of the supine ribcage contribution to tidal volume, followed by the ratio between the neck and the waist circumferences with body height and the supine thoraco-abdominal volumes phase shift angle. Conclusions The pathophysiology of OI ensued a dangerous vicious circle, in which breathing, sleep and nutritional status are tightly linked, and they might all end up in negatively affecting the quality of life. The vicious circle is fed by some intrinsic characteristics of the disease (thoracic, cranial and mandibular deformities) and some bad daily habits of the patients (i.e. physical inactivity and low dietary quality). The former impacts on restricting the respiratory function, the latter makes Olers more prone to experience overweight or obesity. The main consequence is a high incidence of obstructive sleep apnea, which remains an underdiagnosed disorder in individuals with severe OI who are obese, with a neck to height ratio over than 31.6%, and characterized by paradoxical breathing in supine position. A multidisciplinary approach, including evaluations of breathing, sleep and nutrition, is required to better manage the disease and fulfil the maximizing well-being of OI patients.

In hemiplegic patients with stroke, investigating the ipsilesional limb may shed light on the upper limb motor control, impairments and mechanisms of functional recovery. Usually investigation of motor impairment and rehabilitative interventions in patients are performed only based on the contralesional limb. Previous studies found that also the ipsilesional limb presents motor deficits, mostly evaluated with clinical scales which could lack of sensibility. To quantitatively evaluate the performance of the ipsilesional limb in patient with stroke, we conducted an observational study in which 49 hemiplegic patients were enrolled, divided in subgroups based on the severity of impairment of the contralesional limb, and assessed with a kinematic, dynamic and motor control evaluation protocol on their ipsilesional upper limb during reaching movements. Measurements were repeated in the acute and subacute phases and compared to healthy controls. Our results showed that the ipsilesional limb presented lower kinematic and dynamic performances with respect to the healthy controls. Patients performed the movements slower and with a reduced range of motion, indicating a difficulty in controlling the motion of the arm. The energy and the power outputs were lower in both shoulder and elbow joint with a high significance level, confirming the limitation found in kinematics. Moreover, we showed that motor deficits were higher in the acute phase with respect to the subacute one and we found higher significant differences in the group with a more severe contralesional limb impairment. Ipsilesional upper limb biomechanics adds significant and more sensible measures for assessments based on multi-joints dynamics, providing a better insight on the upper limb motor control after stroke. These results could have clinical implications while evaluating and treating ipsilesional and contralesional upper limb impairments and dysfunctions in patients with stroke.

By blocking the release of neurotransmitters, botulinum toxin A (BoNT-A) is an effective treatment for muscle over-activity and pain in stroke patients. BoNT-A has also been reported to increase passive range of motion (p-ROM), the decrease of which is mainly due to muscle shortening (i.e., muscle contracture). Although the mechanism of action of BoNT-A on p-ROM is far from understood, pain relief may be hypothesized to play a role. To test this hypothesis, a retrospective investigation of p-ROM and pain was conducted in post-stroke patients treated with BoNT-A for upper limb hypertonia. Among 70 stroke patients enrolled in the study, muscle tone (Modified Ashworth Scale), pathological postures, p-ROM, and pain during p-ROM assessment (Numeric Rating Scale, NRS) were investigated in elbow flexors (48 patients) and in finger flexors (64 patients), just before and 3–6 weeks after BoNT-A treatment. Before BoNT-A treatment, pathological postures of elbow flexion were found in all patients but one. A decreased elbow p-ROM was found in 18 patients (38%). Patients with decreased p-ROM had higher pain-NRS scores (5.08 ± 1.96, with a pain score ≥8 in 11% of cases) than patients with normal p-ROM (0.57 ± 1.36) (p < 0.001). Similarly, pathological postures of finger flexion were found in all patients but two. A decreased finger p-ROM was found in 14 patients (22%). Pain was more intense in the 14 patients with decreased p-ROM (8.43 ± 1.74, with a pain score ≥ 8 in 86% of cases) than in the 50 patients with normal p-ROM (0.98 ± 1.89) (p < 0.001). After BoNT-A treatment, muscle tone, pathological postures, and pain decreased in both elbow and finger flexors. In contrast, p-ROM increased only in finger flexors. The study discusses that pain plays a pivotal role in the increase in p-ROM observed after BoNT-A treatment.

Abstract Background Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. Methods We conducted a cross-over multi-centric randomized controlled trial to assess the functional improvement at the upper limb level of two arms supports on 36 patients with muscular dystrophy. Participants tested a passive device (i.e., Wrex by Jaeco) and a semi-active solution for gravity compensation (i.e., Armon Ayura). We evaluated devices’ effectiveness with an externally-assessed scale (i.e., Performance of the Upper Limb-PUL-module), a self-perceived scale (i.e., Abilhand questionnaire), and a usability scale (i.e., System Usability Scale). Friedman’s test was used to assess significant functional gain for PUL module and Abilhand questionnaire. Moreover, PUL changes were compared by means of the Friedman’s test. Results Most of the patients improved upper limb function with the use of arm supports (median PUL scores increase of 1–3 points). However, the effectiveness of each device was related to the level of residual ability of the end-user. Slightly impaired patients maintained the same independence without and with assistive devices, even if they reported reduced muscular fatigue for both devices. Moderately impaired patients enhanced their arm functionality with both devices, and they obtained higher improvements with the semi-active one (median PUL scores increase of 9 points). Finally, severely impaired subjects benefited only from the semi-active device (median PUL scores increase of 12 points). Inadequate strength was recognized as a barrier to passive devices. The usability, measured by the System Usability Scale, was evaluated by end-users “good” (70/100 points) for the passive, and “excellent” (80/100 points) for the semi-active device. Conclusions This study demonstrated that assistive devices can improve the quality of life of people suffering from muscular dystrophy. The use of passive devices, despite being low cost and easy to use, shows limitations in the efficacy of the assistance to daily tasks, limiting the assistance to a predefined horizontal plane. The addition of one active degree of freedom improves efficacy and usability especially for medium to severe patients. Further investigations are needed to increase the evidence on the effect of arm supports on quality of life and diseases’ progression in subjects with degenerative disorders. Trial registration clinicaltrials.gov, NCT03127241, Registered 25th April 2017. The clinical trial was also registered as a post-market study at the Italian Ministry of Health.

Italy has been one of the first-hit and most affected countries worldwide by the coronavirus disease 2019 (COVID-19) outbreak, and Lombardy accounts for almost half of all Italian cases. Vulnerable population is the one suffering the most from the current epidemic, without guaranteed access to basic needs. This aspect becomes critical for people experiencing disability, either due or not to COVID-19. To face the pandemic, all the regional health system services, rehabilitation ones included, were forced to radically adapt their operating paradigm and even sometimes to leave their intrinsic mission. The Italian Society of Physical and Rehabilitation Medicine (SIMFER) since the beginning of the outbreak was profoundly involved in the clinical and organizational response to COVID-19. The Lombardy regional group cooperated strictly and continuously with the national group to coordinate rehabilitation processes region wide. The paper presents a brief report of our field experience describing the phases faced since the beginning of the pandemic and suggesting the organizational strategies that could be useful in rehabilitation services for both inpatients and outpatients. Springing from literature and the experience of the Lombardy section of SIMFER, this paper should help clinicians to respond to the need of the disabled patient facing the new COVID-19 outbreak.

Brain plasticity and functional reorganization are mechanisms behind functional motor recovery of patients after an ischemic stroke. The study of resting-state motor network functional connectivity by means of EEG proved to be useful in investigating changes occurring in the information flow and find correlation with motor function recovery. In the literature, most studies applying EEG to post-stroke patients investigated the undirected functional connectivity of interacting brain regions. Quite recently, works started to investigate the directionality of the connections and many approaches or features have been proposed, each of them being more suitable to describe different aspects, e.g., direct or indirect information flow between network nodes, the coupling strength or its characteristic oscillation frequency. Each work chose one specific measure, despite in literature there is not an agreed consensus, and the selection of the most appropriate measure is still an open issue. In an attempt to shed light on this methodological aspect, we propose here to combine the information of direct and indirect coupling provided by two frequency-domain measures based on Granger’s causality, i.e., the directed coherence (DC) and the generalized partial directed coherence (gPDC), to investigate the longitudinal changes of resting-state directed connectivity associated with sensorimotor rhythms α and β, occurring in 18 sub-acute ischemic stroke patients who followed a rehabilitation treatment. Our results showed a relevant role of the information flow through the pre-motor regions in the reorganization of the motor network after the rehabilitation in the sub-acute stage. In particular, DC highlighted an increase in intra-hemispheric coupling strength between pre-motor and primary motor areas, especially in ipsi-lesional hemisphere in both α and β frequency bands, whereas gPDC was more sensitive in the detection of those connection whose variation was mostly represented within the population. A decreased causal flow from contra-lesional premotor cortex towards supplementary motor area was detected in both α and β frequency bands and a significant reinforced inter-hemispheric connection from ipsi to contra-lesional pre-motor cortex was observed in β frequency. Interestingly, the connection from contra towards ipsilesional pre-motor area correlated with upper limb motor recovery in α band. The usage of two different measures of directed connectivity allowed a better comprehension of those coupling changes between brain motor regions, either direct or mediated, which mostly were influenced by the rehabilitation, revealing a particular involvement of the pre-motor areas in the cerebral functional reorganization.

BackgroundStroke is becoming more and more a disease of chronically disabled patients, and new approaches are needed for better outcomes. An intervention based on robot fully assisted upper-limb functional movements is presented.ObjectivesTo test the immediate and sustained effects of the intervention in reducing impairment in chronic stroke and to preliminarily verify the effects on activity.MethodologyNineteen patients with mild-to-severe impairment underwent 12 40-min rehabilitation sessions, 3 per week, of robot-assisted reaching and hand-to-mouth movements. The primary outcome measure was the Fugl-Meyer Assessment (FMA) at T1, immediately after treatment (n = 19), and at T2, at a 6-month follow-up (n = 10). A subgroup of 11 patients was also administered the Wolf Motor Function Test Time (WMFT TIME) and Functional Ability Scale (WMFT FAS) and Motor Activity Log (MAL) Amount Of Use (AOU), and Quality Of Movement (QOM).ResultsAll patients were compliant with the treatment. There was improvement on the FMA with a mean difference with respect to the baseline of 6.2 points at T1, after intervention (n = 19, 95% CI = 4.6–7.8, p < 0.0002), and 5.9 points at T2 (n = 10, 95% CI = 3.6–8.2, p < 0.005). Significant improvements were found at T1 on the WMFT FAS (n = 11, +0.3/5 points, 95% CI = 0.2–0.4, p < 0.004), on the MAL AOU (n = 11, +0.18/5, 95% CI = 0.07–0.29, p < 0.02), and the MAL QOM (n = 11, +0.14/5, 95% CI = 0.08–0.20, p < 0.02).ConclusionsMotor benefits were observed immediately after intervention and at a 6-month follow-up. Reduced impairment would appear to translate to increased activity. Although preliminary, the results are encouraging and lay the foundation for future studies to confirm the findings and define the optimal dose-response curve.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT03208634.

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 (β = −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.

The recovery of symmetric and efficient walking is one of the key goals of a rehabilitation program in patients with stroke. The use of overground exoskeletons alongside conventional gait training might help foster rhythmic muscle activation in the gait cycle toward a more efficient gait. About twenty-nine patients with subacute stroke have been recruited and underwent either conventional gait training or experimental training, including overground gait training using a wearable powered exoskeleton alongside conventional therapy. Before and after the rehabilitation treatment, we assessed: (i) gait functionality by means of clinical scales combined to obtain a Capacity Score, and (ii) gait neuromuscular lower limbs pattern using superficial EMG signals. Both groups improved their ability to walk in terms of functional gait, as detected by the Capacity Score. However, only the group treated with the robotic exoskeleton regained a controlled rhythmic neuromuscular pattern in the proximal lower limb muscles, as observed by the muscular activation analysis. Coherence analysis suggested that the control group (CG) improvement was mediated mainly by spinal cord control, while experimental group improvements were mediated by cortical-driven control. In subacute stroke patients, we hypothesize that exoskeleton multijoint powered fine control overground gait training, alongside conventional care, may lead to a more fine-tuned and efficient gait pattern.

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.

Aims: Continuity of care is an important issue in healthcare for persons after stroke. The present multi-center pilot study investigates the feasibility and efficiency of an innovative approach, the Human Empowerment Aging and Disability (HEAD), for digital-health motor and cognitive rehabilitation. The approach is explored within an in-clinic context (ClinicHEAD) and in continuity of care (HomeHEAD) for persons after chronic stroke.Methods: Thirty-four outpatients with chronic stroke (mean age 55 years, SD 13.7) participated. The HEAD VR protocol was administered in two consecutive phases: Phase I in clinic (ClinicHEAD) consisting of 4 weeks of 12 supervised HEAD rehabilitation sessions (45-min), including motor, cognitive and dual task for all participants; Phase II at home (HomeHEAD) consisted of 60 sessions of the same VR activities, 5 times/week for 3 months. All participants in the ClinicHEAD were allocated (ratio 1:2) to continue with tele-monitored home rehabilitation (HH, N = 11) or to follow usual care (UC, N = 23). Blind evaluation was carried out at baseline, after ClinicHEAD, after 3 months of HomeHEAD and at 3 months Follow-up. Primary outcomes were functional mobility [2-min Walking Test (2MWT)] and cognition [Montreal Cognitive Assessment (MoCA)]. Feasibility and acceptance were assessed with adherence to treatment and the System Usability Satisfaction. Within group analyses were done with dependent samples t-tests, and between groups HomeHEAD comparisons were carried out on change scores with independent samples t-test (p = 0.05, two tailed).Results: The HEAD protocol was feasible with good adherence both in the ClinicHEAD phase (92%) and HomeHEAD (89%) phase, along with good perceived system satisfaction. ClinicHEAD resulted in a significant increase in functional mobility (2MWT, p = 0.02) and cognition (MoCA, p = 0.003) and most secondary outcome variables. At 3 months follow up of HomeHEAD the HH_group showed a further significantly greater maintenance of functional mobility with respect to UC_group (p = 0.04).Conclusion: The HEAD VR protocol was feasible in clinical and at home tele-rehabilitation for persons in the chronic phase after stroke. In clinic the approach was effective in augmenting motor and cognitive abilities and at home it was effective in longterm maintenance of functional mobility, indicating its usefulness in continuity of care.Clinical Trial Registration:ClinicalTrials.gov, NCT03025126.

Aims: We aimed to identify the significant predictors of ecological memory amelioration after the Human Empowerment Aging and Disability (HEAD) rehabilitation program, a multidimensional treatment for chronic neurological diseases.Materials and Methods: Ninety-three patients with Parkinson disease (n = 29), multiple sclerosis (n = 26), and stroke (n = 38) underwent a multidimensional rehabilitation. We focused on changes after treatment on ecological memory (outcome measure) evaluated by Rivermead Behavioral Memory Test, Third Edition (RBMT-3). Minimal clinically important difference (MCID) after treatment were calculated for RBMT-3. The change score on RBMT-3 was categorized in positive effect, stabilization, or no effect of the treatment. Random forest classification identified who significantly benefited from treatment against who did not in terms of ecological memory functioning. Accordingly, logistic regression models were created to identify the best predictors of the treatment effect. A predicted probability value was derived, and the profile of the ideal candidate of HEAD protocol was shown by combining different ranks of significant predictors in a 3 × 3 matrix for each pair of predictors.Results: A significant number of cases reported positive effect of the treatment on ecological memory, with an amelioration over the MCID or a stabilization. The random forest analysis highlighted a discrete accuracy of prediction (>0.60) for all the variables considered at baseline for identifying participants who significantly benefited and who did not from the treatment. Significant logistic regression model (Wald method) showed a predictive role of Montreal Cognitive Assessment (MoCA; p = 0.007), 2-Minute Walk Test (2MWT; p = 0.038), and RBMT-3 (p < 0.001) at baseline on HEAD treatment effect. Finally, we observed a high probability of success in people with higher residual cognitive functioning (MoCA; odds ratio = 1.306) or functional mobility (2MWT; odds ratio = 1.013).Discussion: The HEAD program is a rehabilitation with effects on multiple domains, including ecological memory. Residual level of cognitive and/or motor functioning is a significant predictor of the treatment success. These findings confirm the intrinsic relationship subsisting between motor and cognitive functions and suggest the beneficial effects of physical activity on cognitive functions and vice versa.

This consensus paper is derived from a meeting of an international group of 19 neurological rehabilitation specialists with a combined experience of more than 250 years (range 4–25 years; mean 14.1 years) in treating post-stroke spasticity with botulinum toxin A. The group undertook critical assessments of some recurring practical challenges, not yet addressed in guidelines, through an exten-sive literature search. They then discussed the results in the light of their individual clinical experience and developed consensus statements to present to the wider community who treat such patients. The analysis provides a comprehensive overview of treatment with botulinum toxin A, including the use of adjunctive therapies, within a multidisciplinary context, and is aimed at practicing clinicians who treat patients with post-stroke spasticity and require further practical guidance on the use of botulinum toxin A. This paper does not replicate information published elsewhere, but instead aims to provide practical advice to help optimize the use of botulinum toxin A and maximize clinical outcomes. The recommendations for each topic are summarized in a series of statements. Where published high-quality evidence exists, the recommendations reflect this. However, where evidence is not yet conclusive, the group members issued statements and, in some cas-es, made recommendations based on their clinical experience.

Parkinson's disease (PD) often leads to multifactorial motor and non-motor disabilities with resultant social restrictions. Continuity of care in this pathology, including a tailored home rehabilitation, is crucial to improve or maintain the quality of life for patients. The aim of this multicenter study was to test in a pilot sample of PD patients the efficiency and efficacy of the Human Empowerment Aging and Disability (HEAD) program. The virtual reality HEAD program was administered in two consecutive phases: (1) in clinic (ClinicHEAD, 12 45-minutes sessions, 3 sessions/week); (2) at home (HomeHEAD, 60 45-minutes sessions, 5 sessions/week). Thirty-one PD outpatients were enrolled [mean age (SD) = 66.84 (9.13)]. All patients performed ClinicHEAD, and after allocation (ratio 1:2) were assigned to the HomeHEAD or the Usual Care (UC) group. Motor, cognitive and behavioral outcome measures were assessed at enrollment (T0), at hospital discharge (T1), at 4 (T2) and 7 (T3) months after baseline. After ClinicHEAD (T1 vs. T0 comparison) a significant (p < 0.05) improvement in functional mobility, balance, upper limb mobility, global cognitive function, memory, quality of life and psychological well-being was observed. After the HomeHEAD intervention there was an additional enhancement for upper limb mobility. At T3 follow-up, the UC group that did not continue the HEAD program at home showed a worsening with respect to the HomeHEAD group in balance and functional mobility. Furthermore, in the HomeHEAD group, a positive association was observed between adherence, mental and physical health (SF-12). A trend was also registered between adherence and positive affect. The digital health patient-tailored rehabilitation program resulted in improving motor and non-motor abilities and quality of life in clinical setting, enhancing the motor function in telerehabilitation at home, and maintaining the non-motor abilities and quality of life at follow-up. In the near future, people with PD can be supported also at home with individualized rehabilitation strategies for a better quality of life and wellbeing along with lower costs for society.

Background: Stroke is a disease with a high associated disability burden. Robotic-assisted gait training offers an opportunity for the practice intensity levels associated with good functional walking outcomes in this population. Neural interfacing technology, electroencephalography (EEG), or electromyography (EMG) can offer new strategies for robotic gait re-education after a stroke by promoting more active engagement in movement intent and/or neurophysiological feedback.Objectives: This study identifies the current state-of-the-art and the limitations in direct neural interfacing with robotic gait devices in stroke rehabilitation.Methods: A pre-registered systematic review was conducted using standardized search operators that included the presence of stroke and robotic gait training and neural biosignals (EMG and/or EEG) and was not limited by study type.Results: From a total of 8,899 papers identified, 13 articles were considered for the final selection. Only five of the 13 studies received a strong or moderate quality rating as a clinical study. Three studies recorded EEG activity during robotic gait, two of which used EEG for BCI purposes. While demonstrating utility for decoding kinematic and EMG-related gait data, no EEG study has been identified to close the loop between robot and human. Twelve of the studies recorded EMG activity during or after robotic walking, primarily as an outcome measure. One study used multisource information fusion from EMG, joint angle, and force to modify robotic commands in real time, with higher error rates observed during active movement. A novel study identified used EMG data during robotic gait to derive the optimal, individualized robot-driven step trajectory.Conclusions: Wide heterogeneity in the reporting and the purpose of neurobiosignal use during robotic gait training after a stroke exists. Neural interfacing with robotic gait after a stroke demonstrates promise as a future field of study. However, as a nascent area, direct neural interfacing with robotic gait after a stroke would benefit from a more standardized protocol for biosignal collection and processing and for robotic deployment. Appropriate reporting for clinical studies of this nature is also required with respect to the study type and the participants' characteristics.

The Performance of the Upper Limb (PUL) module is an externally-assessed clinical scale, initially designed for the Duchenne muscular dystrophy population. It provides an upper extremity functional score suitable for both weaker ambulatory and non-ambulatory phases up to the severely impaired patients. It is capable of characterizing overall progression and severity of disease and of tracking the stereotypical proximal-to-distal progressive loss of upper limb function in muscular dystrophy. Since the PUL module has been validated only with Duchenne patients, its use also for Becker and Limb-Girdle muscular dystrophy patients has been here evaluated, to verify its reliability and extend its use. In particular, two different assessors performed this scale on 32 dystrophic subjects in two consecutive days. The results showed that the PUL module has high reliability, both absolute and relative, based on the calculation of Pearson's r (0.9942), Intraclass Correlation Coefficient (0.9943), Standard Error of Measurement (1.36), Minimum Detectable Change (3.77), and Coefficient of Variation (3%). The Minimum Detectable Change, in particular, can be used in clinical trials to perform a comprehensive longitudinal evaluation of the effects of interventions with the lapse of time. According to this analysis, an intervention is effective if the difference in the PUL score between subsequent evaluation points is equal or higher than 4 points; otherwise, the observed effect is not relevant. Inter-rater reliability with ten different assessors was evaluated, and it has been demonstrated that deviation from the mean is lower than calculated Minimum Detectable Change. The present work provides evidence that the PUL module is a reliable and valid instrument for measuring upper limb ability in people with different forms of muscular dystrophy. Therefore, the PUL module might be extended to other pathologies and reliably used in multicenter settings.

Background: Neurological diseases and traumas are major factors that may reduce motor functionality. Functional electrical stimulation is a technique that helps regain motor function, assisting patients in daily life activities and in rehabilitation practices. In this study, we evaluated the efficacy of a treatment based on whole-body Adaptive Functional Electrical Stimulation Kinesitherapy (AFESK™) with the use of muscle synergies, a well-established method for evaluation of motor coordination. The evaluation is performed on retrospectively gathered data of neurological patients executing whole-body movements before and after AFESK-based treatments. Methods: Twenty-four chronic neurologic patients and 9 healthy subjects were recruited in this study. The patient group was further subdivided in 3 subgroups: hemiplegic, tetraplegic and paraplegic. All patients underwent two acquisition sessions: before treatment and after a FES based rehabilitation treatment at the VIKTOR Physio Lab. Patients followed whole-body exercise protocols tailored to their needs. The control group of healthy subjects performed all movements in a single session and provided reference data for evaluating patients’ performance. sEMG was recorded on relevant muscles and muscle synergies were extracted for each patient’s EMG data and then compared to the ones extracted from the healthy volunteers. To evaluate the effect of the treatment, the motricity index was measured and patients’ extracted synergies were compared to the control group before and after treatment. Results: After the treatment, patients’ motricity index increased for many of the screened body segments. Muscle synergies were more similar to those of healthy people. Globally, the normalized synergy similarity in respect to the control group was 0.50 before the treatment and 0.60 after (p < 0.001), with improvements for each subgroup of patients. Conclusions: AFESK treatment induced favorable changes in muscle activation patterns in chronic neurologic patients, partially restoring muscular patterns similar to healthy people. The evaluation of the synergic relationships of muscle activity when performing test exercises allows to assess the results of rehabilitation measures in patients with impaired locomotor functions.

In the last two decades, a growing interest has been focused on gait and balance robot-assisted rehabilitation in children with neurological disabilities. Robotic devices allow the implementation of intensive, task-specific training fostering functional recovery and neuroplasticity phenomena. However, limited attention has been paid to the protocols used in this research framework. This systematic review aims to provide an overview of the existing literature on robotic systems for the rehabilitation of gait and balance in children with neurological disabilities and their rehabilitation applications. The literature search was carried out independently and synchronously by three authors on the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, ScienceDirect, and Google Scholar. The data collected included three subsections referring to clinical, technical, and regulatory aspects. Thirty-one articles out of 81 found on the primary literature search were included in the systematic review. Most studies involved children with cerebral palsy. Only one-third of the studies were randomized controlled trials. Overall, 17 devices (nine end-effector systems and eight exoskeletons) were investigated, among which only 4 (24%) were bore the CE mark. Studies differ on rehabilitation protocols duration, intensity, and outcome measures. Future research should improve both rehabilitation protocols’ and devices’ descriptions.

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.

Upper extremities limitation is a common functional impairment in patients with Multiple Sclerosis (PwMS). Novel technological devices are increasingly used in neurorehabilitation to support motor function improvement and the quantitative assessment of motor performance during training in patients with neurological diseases. In this review, we systematically report the evidence on clinical applications and robotic-assisted arm training (RAT) in functional recovery in PwMS. PubMed/MEDLINE, the Cochrane Library, and the Physiotherapy Evidence Database (PEDro) databases were systematically searched from inception to March 2021. The 10-item PEDro scale assessed the study quality for the RCT, and the AMSTAR-2 was used to assess the quality of the systematic review. The 5-item Oxford CEBM scale was used to rate the level of evidence. A total of 10 studies (161 subjects) were included. The selected studies included one systematic review, four RCTs, one randomized crossover, and four case series. The RCTs were scored as high-quality studies, while the systematic review was determined to be of low quality. Shoulder range of motion, handgrip strength, and proximal arm impairment improved after RAT. Manual dexterity, arm function, and use in daily life also ameliorated arm function. The high clinical heterogeneity of treatment programs and the variety of robot devices affects the generalizability of the study results; therefore, we emphasize the need to standardize the intervention type in future studies that evaluate the role of robotic-assisted training in PwMS. Robot-assisted treatment seems safe and useful to increase manual dexterity and the quality of movement execution in PwMS with moderate to severe disability. Additional studies with an adequate sample size and methodological rigour are warranted to drive definite conclusions.

Enriched environments and tools are believed to promote grasp rehabilitation after stroke. We designed S2, an interactive grasp rehabilitation system consisting of smart objects, custom orthoses for selective grasp constraining, and an electrode array system for forearm NMES. Motor improvements and perceived usability of a new enriched upper limb training system for sub-acute stroke patients was assessed in this interim analysis. Inclusion criteria: sub-acute stroke patients with MMSE>20, ipsilesional MI>80%, and contralesional MI<80%. Effects of 30-min therapy supplements, conventional vs. S2 prototype, are compared through a parallel two-arms dose-matched open-label trial, lasting 27 sessions. Clinical centres: Asklepios Neurologische Klinik Falkenstein, Königstein im Taunus, Germany, and Clinica Villa Beretta, Costa Masnaga, Italy. Assessment scales: ARAT, System Usability, and Technology Acceptance. Methodology: 26 participants were block randomized, allocated to the study (control N=12, experimental N=14) and underwent the training protocol. Among them, 11 participants with ARAT score at inclusion below 35, n = 6 in the experimental group, and n = 5 in the control group were analysed. Results: participants in the enriched treatment group displayed a larger improvement in the ARAT scale (+14.9 pts, pval=0.0494). Perceived usability differed between clinics. No adverse effect was observed in relation to the treatments. Trial status: closed. Conclusions: The S2 system, developed according to shared clinical directives, was tested in a clinical proof of concept. Variations of ARAT scores confirm the feasibility of clinical investigation for hand rehabilitation after stroke.

Background: The recent exponential growth of Digital Health (DH) in the healthcare system provides a crucial transformation in healthcare, answering to alarming threats related to the increasing number of Chronic Neurological Diseases (CNDs). New long-term integrated DH-care approaches, including rehabilitation, are warranted to address these concerns.Methods: The Human Empowerment Aging and Disability (HEAD) rehabilitation program, a new long-term integrated care including DH-care system, was evaluated in terms of efficiency and patient-reported outcome measures (PROMs) in 107 CND patients (30 with Parkinson's Disease, PD; 32 with Multiple Sclerosis, MS; 45 with stroke in chronic stage). All participants followed 1-month of HEAD rehabilitation in clinic (ClinicHEAD: 12 sessions, 3/week), then 1:3 patient was consecutively allocated to 3-months telerehabilitation at home (HomeHEAD: 60 sessions, 5/week). Efficiency (i.e., adherence, usability, and acceptability) and PROMs (i.e., perceived functioning in real-world) were analyzed.Results: The rate of adherence to HEAD treatment in clinic (≥90%) and at home (77%) was high. Usability of HEAD system was judged as good (System Usability Scale, median 70.00) in clinic and even more at home (median 80.00). Similarly, administering the Technology Acceptance Model 3 questionnaire we found high scores both in clinic/at home (Usefulness, mean 5.39 ± 1.41 SD/mean 5.33 ± 1.29 SD; Ease of use, mean 5.55 ± 1.05 SD/ mean 5.45 ± 1.17 SD, External Control, mean 4.94 ± 1.17 SD/mean 5.07 ± 1.01 SD, Relevance, mean 5.68 ± 1.29 SD/mean 5.70 ± 1.13 SD and Enjoyment, mean 5.70 ± 1.40 SD/mean 6.01 ± 1.08 SD). After ClinicHEAD, participation and autonomy in daily routine was maintained or even ameliorated (PD and stroke > MS). Whereas, increased functionality and participation in the MS group was found only after HomeHEAD intervention.Discussion: Our results suggest that a tele-health-based approach is both feasible and efficient in providing rehabilitation care to CNDs from clinic to home. Increasing and maintaining participation as well as autonomy in daily routine are promising findings that open up scenarios for the continuity of care at home through DH-care for CNDs.

BackgroundRecently, muscle synergy analysis has become a standard methodology for extracting coordination patterns from electromyographic (EMG) signals, and for the evaluation of motor control strategies in many contexts. Most previous studies have characterized upper-limb muscle synergies across a limited set of reaching movements. With the aim of future uses in motor control, rehabilitation and other fields, this study provides a comprehensive characterization of muscle synergies in a large set of upper-limb tasks and also considers inter-individual and environmental variability.MethodsSixteen healthy subjects performed upper-limb hand exploration movements for a comprehensive mapping of the upper-limb workspace, which was divided into several sectors (Frontal, Right, Left, Horizontal, and Up). EMGs from representative upper-limb muscles and kinematics were recorded to extract muscle synergies and explore the composition, repeatability and similarity of spatial synergies across subjects and movement directions, in a context of high variability of motion.ResultsEven in a context of high variability, a reduced set of muscle synergies may reconstruct the original EMG envelopes. Composition, repeatability and similarity of synergies were found to be shared across subjects and sectors, even if at a lower extent than previously reported.ConclusionExtending the results of previous studies, which were performed on a smaller set of conditions, a limited number of muscle synergies underlie the execution of a large variety of upper-limb tasks. However, the considered spatial domain and the variability seem to influence the number and composition of muscle synergies. Such detailed characterization of the modular organization of the muscle patterns for upper-limb control in a large variety of tasks may provide a useful reference for studies on motor control, rehabilitation, industrial applications, and sports.

Stroke is the commonest cause of disability. Novel treatments require an improved understanding of the underlying mechanisms of recovery. Fractal approaches have demonstrated that a single metric can describe the complexity of seemingly random fluctuations of physiological signals. We hypothesize that fractal algorithms applied to electroencephalographic (EEG) signals may track brain impairment after stroke. Sixteen stroke survivors were studied in the hyperacute (

Functional Electrical Stimulation (FES) has demonstrated to improve walking ability and to induce the carryover effect, long-lasting persisting improvement. Functional magnetic resonance imaging has been used to investigate effective connectivity differences and longitudinal changes in a group of chronic stroke patients that attended a FES-based rehabilitation program for foot-drop correction, distinguishing between carryover effect responders and non-responders, and in comparison with a healthy control group. Bayesian hierarchical procedures were employed, involving nonlinear models at within-subject level—dynamic causal models—and linear models at between-subjects level. Selected regions of interest were primary sensorimotor cortices (M1, S1), supplementary motor area (SMA), and angular gyrus. Our results suggest the following: (i) The ability to correctly plan the movement and integrate proprioception information might be the features to update the motor control loop, towards the carryover effect, as indicated by the reduced sensitivity to proprioception input to S1 of FES non-responders; (ii) FES-related neural plasticity supports the active inference account for motor control, as indicated by the modulation of SMA and M1 connections to S1 area; (iii) SMA has a dual role of higher order motor processing unit responsible for complex movements, and a superintendence role in suppressing standard motor plans as external conditions changes.

There is extensive literature supporting the efficacy of botulinum toxin (BoNT-A) for the treatment of post-stroke spasticity, however, there remain gaps in the routine management of patients with post-stroke spasticity. A panel of 21 Italian experts was selected to participate in this web-based survey Delphi process to provide guidance that can support clinicians in the decision-making process. There was a broad consensus among physicians that BoNT-A intervention should be administered as soon as the spasticity interferes with the patients’ clinical condition. Patients monitoring is needed over time, a follow-up of 4–6 weeks is considered necessary. Furthermore, physicians agreed that treatment should be offered irrespective of the duration of the spasticity. The Delphi consensus also stressed the importance of patient-centered goals in order to satisfy the clinical needs of the patient regardless of time of onset or duration of spasticity. The findings arising from this Delphi process provide insights into the unmet needs in managing post-stroke spasticity from the clinician’s perspective and provides guidance for physicians for the utilization of BoNT-A for the treatment of post-stroke spasticity in daily practice.

Background: Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training. Methods: A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS). Results: The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2. Conclusions: The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

Background: The efficacy of robot-assisted rehabilitation as a technique for achieving motor recovery is still being debated. The effects of robotic assistance are generally measured using standard clinical assessments. Few studies have investigated the value of human-centered instrumental analysis, taking the modular organization of the human neuromotor system into account in assessing how stroke survivors interact with robotic set-ups. In this paper, muscle synergy analysis was coupled with clustering procedures to elucidate the effect of human-robot interaction on the spatial and temporal features, and directional tuning of motor modules during robot-assisted movements.Methods: Twenty-two stroke survivors completed a session comprising a series of hand-to-mouth movements with and without robotic assistance. Patients were assessed instrumentally, recording kinematic, and electromyographic data to extract spatial muscle synergies and their temporal components. Patients' spatial synergies were grouped by means of a cluster analysis, matched pairwise across conditions (free and robot-assisted movement), and compared in terms of their spatial and temporal features, and directional tuning, to examine how robotic assistance altered their motor modules.Results: Motor synergies were successfully extracted for all 22 patients in both conditions. Seven clusters (spatial synergies) could describe the original datasets, in both free and robot-assisted movements. Interacting with the robot slightly altered the spatial synergies' features (to a variable extent), as well as their temporal components and directional tuning.Conclusions: Slight differences were identified in the characteristics of spatial synergies, temporal components and directional tuning of the motor modules of stroke survivors engaging in free and robot-assisted movements. Such effects are worth investigating in the framework of a modular description of the neuromusculoskeletal system to shed more light on human-robot interaction, and the effects of robotic assistance and rehabilitation.

Stroke-related locomotor impairments are often associated with abnormal timing and intensity of recruitment of the affected and non-affected lower limb muscles. Restoring the proper lower limbs muscles activation is a key factor to facilitate recovery of gait capacity and performance, and to reduce maladaptive plasticity. Ekso is a wearable powered exoskeleton robot able to support over-ground gait training. The user controls the exoskeleton by triggering each single step during the gait cycle. The fine-tuning of the exoskeleton control system is crucial—it is set according to the residual functional abilities of the patient, and it needs to ensure lower limbs powered gait to be the most physiological as possible. This work focuses on the definition of an automatic calibration procedure able to detect the best Ekso setting for each patient. EMG activity has been recorded from Tibialis Anterior, Soleus, Rectus Femoris, and Semitendinosus muscles in a group of 7 healthy controls and 13 neurological patients. EMG signals have been processed so to obtain muscles activation patterns. The mean muscular activation pattern derived from the controls cohort has been set as reference. The developed automatic calibration procedure requires the patient to perform overground walking trials supported by the exoskeleton while changing parameters setting. The Gait Metric index is calculated for each trial, where the closer the performance is to the normative muscular activation pattern, in terms of both relative amplitude and timing, the higher the Gait Metric index is. The trial with the best Gait Metric index corresponds to the best parameters set. It has to be noted that the automatic computational calibration procedure is based on the same number of overground walking trials, and the same experimental set-up as in the current manual calibration procedure. The proposed approach allows supporting the rehabilitation team in the setting procedure. It has been demonstrated to be robust, and to be in agreement with the current gold standard (i.e., manual calibration performed by an expert engineer). The use of a graphical user interface is a promising tool for the effective use of an automatic procedure in a clinical context.

Exoskeleton devices for upper limb neurorehabilitation are one of the most exploited solutions for the recovery of lost motor functions. By providing weight support, passively compensated exoskeletons allow patients to experience upper limb training. Transparency is a desirable feature of exoskeletons that describes how the device alters free movements or interferes with spontaneous muscle patterns. A pilot study on healthy subjects was conducted to evaluate the feasibility of assessing transparency in the framework of muscle synergies. For such purpose, the LIGHTarm exoskeleton prototype was used. LIGHTarm provides gravity support to the upper limb during the execution of movements in the tridimensional workspace. Surface electromyography was acquired during the execution of three daily life movements (reaching, hand-to-mouth, and hand-to-nape) in three different conditions: free movement, exoskeleton-assisted (without gravity compensation), and exoskeleton-assisted (with gravity compensation) on healthy people. Preliminary results suggest that the muscle synergy framework may provide valuable assessment of user transparency and weight support features of devices aimed at rehabilitation.

Mobile Brain/Body Imaging (MoBI) is rapidly gaining traction as a new imaging modality to study how cognitive processes support locomotion. Electroencephalogram (EEG) and electromyogram (EMG), due to their time resolution, non-invasiveness and portability are the techniques of choice for MoBI, but synchronization requirements among others restrict its use to high-end research facilities. Here we test the effectiveness of a technique that enables us to achieve MoBI-grade synchronization of EEG and EMG, even when other strategies (such as Lab Streaming Layer (LSL)) cannot be used e.g., due to the unavailability of proprietary Application Programming Interfaces (APIs), which is often the case in clinical settings. The proposed strategy is that of aligning several spikes at the beginning and end of the session. We delivered a train of spikes to the EEG amplifier and EMG electrodes every 2 s over a 10-min time period. We selected a variable number of spikes (from 1 to 10) both at the beginning and end of the time series and linearly resampled the data so as to align them. We then compared the misalignment of the “middle” spikes over the whole recording to test for jitter and synchronization drifts, highlighting possible nonlinearities (due to hardware filters) and estimated the maximum length of the recording to achieve a [−5 to 5] ms misalignment range. We demonstrate that MoBI-grade synchronization can be achieved within 10-min recordings with a 1.7 ms jitter and [−5 5] ms misalignment range. We show that repeated spike delivery can be used to test online synchronization options and to troubleshoot synchronization issues over EEG and EMG. We also show that synchronization cannot rely only on the equipment sampling rate advertised by manufacturers. The synchronization strategy described can be used virtually in every clinical environment, and may increase the interest among a broader spectrum of clinicians and researchers in the MoBI framework, ultimately leading to a better understanding of the brain processes underlying locomotion control and the development of more effective rehabilitation approaches.

BackgroundA deep characterization of neurological patients is a crucial step for a detailed knowledge of the pathology and maximal exploitation and customization of the rehabilitation therapy. The muscle synergies analysis was designed to investigate how muscles coactivate and how their eliciting commands change in time during movement production. Few studies investigated the value of muscle synergies for the characterization of neurological patients before rehabilitation therapies. In this article, the synergy analysis was used to characterize a group of chronic poststroke hemiplegic patients.MethodsTwenty-two poststroke patients performed a session composed of a sequence of 3D reaching movements. They were assessed through an instrumental assessment, by recording kinematics and electromyography to extract muscle synergies and their activation commands. Patients’ motor synergies were grouped by the means of cluster analysis. Consistency and characterization of each cluster was assessed and clinically profiled by comparison with standard motor assessments.ResultsMotor synergies were successfully extracted on all 22 patients. Five basic clusters were identified as a trade-off between clustering precision and synthesis power, representing: healthy-like activations, two shoulder compensatory strategies, two elbow predominance patterns. Each cluster was provided with a deep characterization and correlation with clinical scales, range of motion, and smoothness.ConclusionThe clustering of muscle synergies enabled a pretherapy characterization of patients. Such technique may affect several aspects of the therapy: prediction of outcomes, evaluation of the treatments, customization of doses, and therapies.

The correct choice and customization of an orthosis are crucial to obtain the best comfort and efficiency. This study explored the feasibility of a multivariate quantitative assessment of the functional efficiency of lower limb orthosis through a novel wearable system. Gait basographic parameters and energetic indexes were analysed during a Six-Minute Walking Test (6-MWT) through a cost-effective, non-invasive polygraph device, with a multichannel wireless transmission, that carried out electro-cardiograph (ECG); impedance-cardiograph (ICG); and lower-limb accelerations detection. Four subjects affected by Post-Polio Syndrome (PPS) were recruited. The wearable device and the semi-automatic post-processing software provided a novel set of objective data to assess the overall efficiency of the patient-orthosis system. Despite the small number of examined subjects, the results obtained with this new approach encourage the application of the method thus enlarging the dataset to validate this promising protocol and measuring system in supporting clinical decisions and out of a laboratory environment.

Since the release of the first Kinect in 2011, low-cost technologies for upper-limb evaluation has been employed frequently for rehabilitation purposes. However, a limited number of studies have assessed the potential of the Kinect V2 for motor evaluations. In this paper, a simple biomechanical protocol has been developed, in order to assess the performances of healthy people and patients, during daily-life reaching movements, with focus on some of the patients’ common compensatory strategies. The assessment considers shoulder range of motion, elbow range of motion, trunk compensatory strategies, and movement smoothness. Seventy-seven healthy people and twenty post-stroke patients participated to test the biomechanical assessment. The testing protocol included four different experimental conditions: (1) dominant limb and (2) non-dominant limb of 77 healthy people, and (3) the more impaired limb of 20 post-stroke hemiparetic patients, and (4) the less-impaired limb of 11 patients (subgroup of the original 20). Biomechanical performances of the four groups were compared. Results showed that the dominant and non-dominant limbs of healthy people had comparable performances (p > 0.05). On the contrary, condition (3) showed statistically significant differences between the healthy dominant/non-dominant limb and the less-affected limb in hemiparetic patients, for all parameters of assessment (p < 0.001). In some cases, the less-affected limb of the patients also showed statistical differences (p < 0.05), with respect to the healthy people. Such results suggest that Kinect V2 has the potential for being employed at home, laboratory or clinical environment, for the evaluation of patients’ motor performances.

Neurorehabilitation effective delivery for stroke is likely to be improved by establishing a mechanistic understanding of how to enhance adaptive plasticity. Functional electrical stimulation is effective at reducing poststroke foot drop; in some patients, the effect persists after therapy has finished with an unknown mechanism. We used fMRI to examine neural correlates of functional electrical stimulation key elements, volitional intent to move and concurrent stimulation, in a group of chronic stroke patients receiving functional electrical stimulation for foot-drop correction. Patients exhibited task-related activation in a complex network, sharing bilateral sensorimotor and supplementary motor activation with age-matched controls. We observed consistent separation of patients with and without carryover effect on the basis of brain responses. Patients who experienced the carryover effect had responses in supplementary motor area that correspond to healthy controls; the interaction between experimental factors in contralateral angular gyrus was seen only in those without carryover. We suggest that the functional electrical stimulation carryover mechanism of action is based on movement prediction and sense of agency/body ownership—the ability of a patient to plan the movement and to perceive the stimulation as a part of his/her own control loop is important for carryover effect to take place.

Multidomain instrumental evaluation of post-stroke chronic patients, coupled with standard clinical assessments, has rarely been exploited in the literature. Such an approach may be valuable to provide comprehensive insight regarding patients’ status, as well as orienting the rehabilitation therapies. Therefore, we propose a multidomain analysis including clinically compliant methods as electroencephalography (EEG), electromyography (EMG), kinematics, and clinical scales. The framework of upper-limb robot-assisted rehabilitation is selected as a challenging and promising scenario to test the multi-parameter evaluation, with the aim to assess whether and in which domains modifications may take place. Instrumental recordings and clinical scales were administered before and after a month of intensive robotic therapy of the impaired upper limb, on five post-stroke chronic hemiparetic patients. After therapy, all patients showed clinical improvement and presented pre/post modifications in one or several of the other domains as well. All patients performed the motor task in a smoother way; two of them appeared to change their muscle synergies activation strategies, and most subjects showed variations in their brain activity, both in the ipsi- and contralateral hemispheres. Changes highlighted by the new multiparametric instrumental approach suggest a recovery trend in agreement with clinical scales. In addition, by jointly demonstrating lateralization of brain activations, changes in muscle recruitment and the execution of smoother trajectories, the new approach may help distinguish between true functional recovery and the adoption of suboptimal compensatory strategies. In the light of these premises, the multi-domain approach may allow a finer patient characterization, providing a deeper insight into the mechanisms underlying the relearning procedure and the level (neuro/muscular) at which it occurred, at a relatively low expenditure. The role of this quantitative description in defining a personalized treatment strategy is of great interest and should be addressed in future studies.