The impact of decision tools during oncological consultation with lung cancer patients: A systematic review within the I3LUNG project.

INTRODUCTION: To date, lung cancer is one of the most lethal diagnoses worldwide. A variety of lung cancer treatments and modalities are available, which are generally presented during the patient and doctor consultation. The implementation of decision tools to facilitate patient's decision-making and the management of their healthcare process during medical consultation is fundamental. Studies have demonstrated that decision tools are helpful to promote health management and decision-making of lung cancer patients during consultations. The main aim of the present work within the I3LUNG project is to systematically review the implementation of decision tools to facilitate medical consultation about oncological treatments for lung cancer patients. METHODS: In the present study, we conducted a systematic review following the PRISMA guidelines. We used an electronic computer-based search involving three databases, as follows: Embase, PubMed, and Scopus. 10 articles met the inclusion criteria and were included. They explicitly refer to decision tools in the oncological context, with lung cancer patients. RESULTS: The discussion highlights the most encouraging results about the positive role of decision aids during medical consultations about oncological treatments, especially regarding anxiety, decision-making, and patient knowledge. However, no one main decision aid tool emerged as essential. Opting for a more recent timeframe to select eligible articles might shed light on the current array of decision aid tools available. CONCLUSION: Future review efforts could utilize alternative search strategies to explore other lung cancer-specific outcomes during medical consultations for treatment decisions and the implementation of decision aid tools. Engaging with experts in the fields of oncology, patient decision-making, or health communication could provide valuable insights and recommendations for relevant literature or research directions that may not be readily accessible through traditional search methods. The development of guidelines for future research were provided with the aim to promote decision aids focused on patients' needs.

Automatic Spontaneous Speech Analysis for the Detection of Cognitive Functional Decline in Older Adults: Multilanguage Cross-Sectional Study.

BACKGROUND: The rise in life expectancy is associated with an increase in long-term and gradual cognitive decline. Treatment effectiveness is enhanced at the early stage of the disease. Therefore, there is a need to find low-cost and ecological solutions for mass screening of community-dwelling older adults. OBJECTIVE: This work aims to exploit automatic analysis of free speech to identify signs of cognitive function decline. METHODS: A sample of 266 participants older than 65 years were recruited in Italy and Spain and were divided into 3 groups according to their Mini-Mental Status Examination (MMSE) scores. People were asked to tell a story and describe a picture, and voice recordings were used to extract high-level features on different time scales automatically. Based on these features, machine learning algorithms were trained to solve binary and multiclass classification problems by using both mono- and cross-lingual approaches. The algorithms were enriched using Shapley Additive Explanations for model explainability. RESULTS: In the Italian data set, healthy participants (MMSE score≥27) were automatically discriminated from participants with mildly impaired cognitive function (20≤MMSE score≤26) and from those with moderate to severe impairment of cognitive function (11≤MMSE score≤19) with accuracy of 80% and 86%, respectively. Slightly lower performance was achieved in the Spanish and multilanguage data sets. CONCLUSIONS: This work proposes a transparent and unobtrusive assessment method, which might be included in a mobile app for large-scale monitoring of cognitive functionality in older adults. Voice is confirmed to be an important biomarker of cognitive decline due to its noninvasive and easily accessible nature.

REPORT-SCS: minimum reporting standards for spinal cord stimulation studies in spinal cord injury.

Objective.Electrical spinal cord stimulation (SCS) has emerged as a promising therapy for recovery of motor and autonomic dysfunctions following spinal cord injury (SCI). Despite the rise in studies using SCS for SCI complications, there are no standard guidelines for reporting SCS parameters in research publications, making it challenging to compare, interpret or reproduce reported effects across experimental studies.Approach.To develop guidelines for minimum reporting standards for SCS parameters in pre-clinical and clinical SCI research, we gathered an international panel of expert clinicians and scientists. Using a Delphi approach, we developed guideline items and surveyed the panel on their level of agreement for each item.Main results.There was strong agreement on 26 of the 29 items identified for establishing minimum reporting standards for SCS studies. The guidelines encompass three major SCS categories: hardware, configuration and current parameters, and the intervention.Significance.Standardized reporting of stimulation parameters will ensure that SCS studies can be easily analyzed, replicated, and interpreted by the scientific community, thereby expanding the SCS knowledge base and fostering transparency in reporting.

Improvement of speed-accuracy tradeoff during practice of a point-to-point task in children with acquired dystonia.

The tradeoff between speed and accuracy is a well-known constraint for human movement, but previous work has shown that this tradeoff can be modified by practice, and the quantitative relationship between speed and accuracy may be an indicator of skill in some tasks. We have previously shown that children with dystonia are able to adapt their movement strategy in a ballistic throwing game to compensate for increased variability of movement. Here, we test whether children with dystonia can adapt and improve skills learned on a trajectory task. We use a novel task in which children move a spoon with a marble between two targets. Difficulty is modified by changing the depth of the spoon. Our results show that both healthy children and children with acquired dystonia move more slowly with the more difficult spoons, and both groups improve the relationship between speed and spoon difficulty following 1 wk of practice. By tracking the marble position in the spoon, we show that children with dystonia use a larger fraction of the available variability, whereas healthy children adopt a much safer strategy and remain farther from the margins, as well as learning to adapt and have more control over the marble's utilized area by practice. Together, our results show that both healthy children and children with dystonia choose trajectories that compensate for risk and inherent variability, and that the increased variability in dystonia can be modified with continued practice.NEW & NOTEWORTHY This study provides insights into the adaptability of children with dystonia in learning a point-to-point task. We show that these children adjust their strategies to account for increased difficulty in the task. Our findings underscore the potential of task-specific practice in improving motor skills and show higher level of signal-dependent noise can be controlled through repetition and learned strategies, which provides an avenue for the quantitative evaluation of rehabilitation strategies in this challenging group.

Improvement of speed-accuracy tradeoff during practice of a point to point task in children with secondary dystonia.

The tradeoff between speed and accuracy is a well-known constraint for human movement, but previous work has shown that this tradeoff can be modified by practice, and the quantitative relationship between speed and accuracy may be an indicator of skill in some tasks. We have previously shown that children with dystonia are able to adapt their movement strategy in a ballistic throwing game to compensate for increased variability of movement. Here we test whether children with dystonia can adapt and improve skill learnt on a trajectory task. We use a novel task in which children move a spoon with a marble between two targets. Difficulty is modified by changing the depth of the spoon. Our results show that both healthy children and children with secondary dystonia move more slowly with the more difficult spoons, and both groups improve the relationship between speed and spoon difficulty following one week of practice. By tracking the marble position in the spoon, we show that children with dystonia use a larger fraction of the available variability, whereas healthy children adopt a much safer strategy and remain farther from the margins, as well as learning to adopt and have more control over the marble's utilized area by practice. Together, our results show that both healthy children and children with dystonia choose trajectories that compensate for risk and inherent variability, and that the increased variability in dystonia can be modified with continued practice.

The EU-funded I3LUNG Project: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy.

Although immunotherapy (IO) has changed the paradigm for the treatment of patients with advanced non-small cell lung cancers (aNSCLC), only around 30% to 50% of treated patients experience a long-term benefit from IO. Furthermore, the identification of the 30 to 50% of patients who respond remains a major challenge, as programmed Death-Ligand 1 (PD-L1) is currently the only biomarker used to predict the outcome of IO in NSCLC patients despite its limited efficacy. Considering the dynamic complexity of the immune system-tumor microenvironment (TME) and its interaction with the host's and patient's behavior, it is unlikely that a single biomarker will accurately predict a patient's outcomes. In this scenario, Artificial Intelligence (AI) and Machine Learning (ML) are becoming essential to the development of powerful decision-making tools that are able to deal with this high-complexity and provide individualized predictions to better match treatments to individual patients and thus improve patient outcomes and reduce the economic burden of aNSCLC on healthcare systems. I3LUNG is an international, multicenter, retrospective and prospective, observational study of patients with aNSCLC treated with IO, entirely funded by European Union (EU) under the Horizon 2020 (H2020) program. Using AI-based tools, the aim of this study is to promote individualized treatment in aNSCLC, with the goals of improving survival and quality of life, minimizing or preventing undue toxicity and promoting efficient resource allocation. The final objective of the project is the construction of a novel, integrated, AI-assisted data storage and elaboration platform to guide IO administration in aNSCLC, ensuring easy access and cost-effective use by healthcare providers and patients.

Video-based Goniometer Applications for Measuring Knee Joint Angles during Walking in Neurological Patients: A Validity, Reliability and Usability Study.

Easy-to-use evaluation of Range Of Motion (ROM) during walking is necessary to make decisions during neurological rehabilitation programs and during follow-up visits in clinical and remote settings. This study discussed goniometer applications (DrGoniometer and Angles - Video Goniometer) that measure knee joint ROM during walking through smartphone cameras. The primary aim of the study is to test the inter-rater and intra-rater reliability of the collected measurements as well as their concurrent validity with an electro-goniometer. The secondary aim is to evaluate the usability of the two mobile applications. A total of 22 patients with Parkinson's disease (18 males, age 72 (8) years), 22 post-stroke patients (17 males, age 61 (13) years), and as many healthy volunteers (8 males, age 45 (5) years) underwent knee joint ROM evaluations during walking. Clinicians and inexperienced examiners used the two mobile applications to calculate the ROM, and then rated their perceived usability through the System Usability Scale (SUS). Intraclass correlation coefficients (ICC) and correlation coefficients (corr) were calculated. Both applications showed good reliability (ICC > 0.69) and validity (corr > 0.61), and acceptable usability (SUS > 68). Smartphone-based video goniometers could be used to assess the knee ROM during walking in neurological patients, because of their acceptable degree of reliability, validity and usability.

Adaptive Hybrid FES-Force Controller for Arm Exosuit.

Patients suffering from neuromuscular diseases experience motor disabilities which hinder their independence during activities of daily living (ADLs). For such impaired subjects, robotic devices and Functional Electrical Stimulation (FES) are technologies commonly used to rehabilitate lost functions. Nevertheless, both systems present some limitations, and merging FES and robots in Hybrid Robotic Rehabilitation Systems allows to overcome these boundaries. Here we propose for the first time a hybrid cooperative controller involving FES and a soft wearable upper arm exosuit to rehabilitate elbow movements. We tested the designed hybrid controller on six healthy participants. The results showed how the proposed hybrid controller allowed the wearers to perform flexion movements with no significant decrease in accuracy and precision with respect to the exosuit alone, while significantly decreasing the fatigue level by about 63% and delaying its onset with respect to the FES action alone.

Upper limb soft robotic wearable devices: a systematic review.

INTRODUCTION: Soft robotic wearable devices, referred to as exosuits, can be a valid alternative to rigid exoskeletons when it comes to daily upper limb support. Indeed, their inherent flexibility improves comfort, usability, and portability while not constraining the user's natural degrees of freedom. This review is meant to guide the reader in understanding the current approaches across all design and production steps that might be exploited when developing an upper limb robotic exosuit. METHODS: The literature research regarding such devices was conducted in PubMed, Scopus, and Web of Science. The investigated features are the intended scenario, type of actuation, supported degrees of freedom, low-level control, high-level control with a focus on intention detection, technology readiness level, and type of experiments conducted to evaluate the device. RESULTS: A total of 105 articles were collected, describing 69 different devices. Devices were grouped according to their actuation type. More than 80% of devices are meant either for rehabilitation, assistance, or both. The most exploited actuation types are pneumatic (52%) and DC motors with cable transmission (29%). Most devices actuate 1 (56%) or 2 (28%) degrees of freedom, and the most targeted joints are the elbow and the shoulder. Intention detection strategies are implemented in 33% of the suits and include the use of switches and buttons, IMUs, stretch and bending sensors, EMG and EEG measurements. Most devices (75%) score a technology readiness level of 4 or 5. CONCLUSION: Although few devices can be considered ready to reach the market, exosuits show very high potential for the assistance of daily activities. Clinical trials exploiting shared evaluation metrics are needed to assess the effectiveness of upper limb exosuits on target users.

The reliability of gait parameters captured via instrumented walkways: a systematic review and meta-analysis.

INTRODUCTION: Electronic pressure-sensitive walkways are commonly available solutions to quantitatively assess gait parameters for clinical and research purposes. Many studies have evaluated their measurement properties in different conditions with variable findings. In order to be informed about the current evidence of their reliability for optimal clinical and scientific decision making, this systematic review provided a quantitative synthesis of the test-retest reliability and minimal detectable change of the captured gait parameters across different test conditions (single and cognitive dual-task conditions) and population groups. EVIDENCE ACQUISITION: A literature search was conducted in PubMed, Embase, and Scopus until November 2021 to identify articles that examined the test-retest reliability properties of the gait parameters captured by pressure-sensitive walkways (gait speed, cadence, stride length and time, double support time, base of support) in adult healthy individuals or patients. The methodological quality was rated using the Consensus-Based Standards for the Selection of Health Measurement Instruments Checklist. Data were meta-analyzed on intraclass correlation coefficient to examine the test-retest relative reliability. Quantitative synthesis was performed for absolute reliability, examined by the weighted average of minimal detectable change values. EVIDENCE SYNTHESIS: A total of 44 studies were included in this systematic review. The methodological quality was adequate in half of the included studies. The main finding was that pressure-sensitive walkways are reliable tools for objective assessment of spatial and temporal gait parameters both in single-and cognitive dual-task conditions. Despite few exceptions, the review identified intraclass correlation coefficient higher than 0.75 and minimal detectable change lower than 30%, demonstrating satisfactory relative and absolute reliability in all examined populations (healthy adults, elderly, patients with cognitive impairment, spinocerebellar ataxia type 14, Huntington's disease, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, spinal cord injury, stroke or vestibular dysfunction). CONCLUSIONS: Current evidence suggested that, despite different populations and testing protocols used in the included studies, the test-retest reliability of the examined gait parameters was acceptable under single and cognitive dual-task conditions. Further high-quality studies with powered sample sizes are needed to examine the reliability findings of the currently understudied and unexplored pathologies and test conditions.

Multimodal exercises integrated with cognitive-behavioural therapy improve disability of patients with failed back surgery syndrome: a randomized controlled trial with one-year follow-up.

PURPOSE: To evaluate the effect of multimodal exercises integrated with cognitive-behavioural therapy on disability, pain, and quality of life in patients suffering from failed back surgery syndrome (FBSS), and to appraise its extent in the long term. METHODS: By means of a parallel-group superiority-controlled trial, 150 outpatients were randomly assigned to a 10-week individual-based multimodal programme of task-oriented exercises integrated with cognitive-behavioural therapy (experimental group, 75 patients) or individual-based general physiotherapy (control group, 75 patients). Before treatment, 10 weeks later (post-treatment), and 12 months after the end of treatment, the Oswestry Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophising Scale, a pain intensity numerical rating scale and the Short-Form Health Survey were evaluated. Linear mixed model analysis for repeated measures was carried out for each outcome measure. RESULTS: Significant group (p < 0.001), time (p < 0.001), and time-by-group interaction (p < 0.001) effects were found for all outcome measures. Concerning disability, between-group differences (95% confidential interval) in favour of the experimental group of -9 (-10.7; -7.3) after training and of -13.2 (-14.7; -11.7) at follow-up were found. Also, kinesiophobia, catastrophising and pain showed significant between-group differences of 9, 12.5 and 1.7 points, respectively. CONCLUSION: The multimodal intervention proposed was superior to general physiotherapy in reducing disability, kinesiophobia, catastrophising, and enhancing the quality of life of patients with FBSS. The effects were reinforced one year after the programme ended.IMPLICATIONS FOR REHABILITATIONMultimodal exercises integrated with cognitive-behavioural therapy induced significant improvements in disability, pain, kinesiophobia, catastrophising, and quality of life of subjects with Failed Back Surgery Syndrome.A well-integrated rehabilitative team which contributes towards reaching intervention goals is advised.Physiotherapists should adopt task-oriented exercises to promote an earlier return to common activities of disabled patients.Psychologists should explain how to modify useless beliefs and support adequate behaviours, in order to produce constructive attitudes towards perceived disability.

Comparing Fatigue Reducing Stimulation Strategies During Cycling Induced by Functional Electrical Stimulation: a Case Study with one Spinal Cord Injured Subject.

This case study was designed starting from our experience at CYBATHLON 2020. The specific aim of this work was to compare the effectiveness of different fatigue reducing stimulation strategies during cycling induced by Functional Electrical Stimulation (FES). The compared stimulation strategies were: traditional constant frequency trains (CFTs) at 30 and 40Hz, doublet frequency trains (DFTs) and spatially distributed sequential stimulation (SDSS) on the quadriceps muscles. One Spinal Cord Injured (SCI) subject (39 years, T5-T6, male, ASIA A) was involved in 12 experimental sessions during which the four strategies were tested in a randomized order during FES-induced cycling performed on a passive trike at a constant cadence of 35 RPM. FES was delivered to four muscle groups (quadriceps, gluteal muscles, hamstrings and gastrocnemius) for each leg. The performance was evaluated in terms of saturation time (i.e., the time elapsed from the beginning of the stimulation until the predetermined maximum value of current amplitude is reached) and root mean square error (RMSE) of the actual cadence with respect to the target value. SDSS achieved a statistical lower saturation time and a qualitative higher RMSE of the cadence with respect to CFTs both at 30 and 40Hz.Clinical relevance- Conversely to previous literature, SDSS seems to be ineffective to reduce muscle fatigue during FES-induced cycling. Further experiments are needed to confirm this result.

Adaptive Cooperative Control for Hybrid FES-Robotic Upper Limb Devices: a Simulation Study.

Robotic systems and Functional Electrical Stimulation (FES) are common technologies exploited in motor rehabilitation. However, they present some limits. To overcome the weaknesses of both approaches, hybrid cooperative devices have been developed, which combine the action of the robot and that of the electrically stimulated muscles on the same joint. In this work, we present a novel adaptive cooperative controller for the rehabilitation of the upper limb. The controller comprises an allocator - which breaks down the reference torque between the motor and the FES a-priori contributions based on muscle fatigue estimation - an FES closed-loop controller, and an impedance control loop on the motor to correct trajectory tracking errors. The controller was tested in simulation environment reproducing elbow flexion/extension movements. Results showed that the controller could reduce motor torque requirements with respect to the motor-only case, at the expense of trajectory tracking performance. Moreover, it could improve fatigue management with respect to the FES-only case. In conclusion, the proposed control strategy provides a good trade-off between motor torque consumption and trajectory tracking performance, while the allocator manages fatigue-related phenomena.Clinical relevance-The use of allocation proves to be effective in both reducing motor torque and FES-induced muscle fatigue and might be an effective solution for hybrid FES-robotic systems.

The Effectiveness of Robot- vs. Virtual Reality-Based Gait Rehabilitation: A Propensity Score Matched Cohort.

Robot assisted gait training (RAGT) and virtual reality plus treadmill training (VRTT) are two technologies that can support locomotion rehabilitation in children and adolescents affected by acquired brain injury (ABI). The literature provides evidence of their effectiveness in this population. However, a comparison between these methods is not available. This study aims at comparing the effectiveness of RAGT and VRTT for the gait rehabilitation of children and adolescents suffering from ABI. This is a prospective cohort study with propensity score matching. Between October 2016 and September 2018, all patients undergoing an intensive gait rehabilitation treatment based on RAGT or VRTT were prospectively observed. To minimize selection bias associated with the study design, patients who underwent RAGT or VRTT were retrospectively matched for age, gender, time elapsed from injury, level of impairment, and motor impairment using propensity score in a matching ratio of 1:1. Outcome measures were Gross Motor Function Mesure-88 (GMFM-88), six-min walking test (6MWT), Gillette Functional Assessment Questionnaire (FAQ), and three-dimensional gait analysis (GA). The FAQ and the GMFM-88 had a statistically significant increase in both groups while the 6MWT improved in the RAGT group only. GA highlighted changes at the proximal level in the RAGT group, and at the distal district in the VRTT group. Although preliminary, this work suggests that RAGT and VRTT protocols foster different motor improvements, thus recommending to couple the two therapies in the paediatric population with ABI.

Multidisciplinary program based on early management of psychological factors reduces disability of patients with subacute low back pain: one-year results of a randomized controlled study.

BACKGROUND: Multidisciplinary rehabilitation induces disability improvement, pain reduction and favors return-to-work in patients with subacute low back pain (LBP). Current research advises additional high-quality trials. AIM: The aim of this study is to test the effect of a multidisciplinary rehabilitative program incorporating cognitive-behavioral interventions compared to general physiotherapy alone to treat subacute LBP, and to appraise its long-term extent. DESIGN: Randomised parallel-group superiority-controlled trial. SETTING: Outpatient rehabilitation hospital. POPULATION: One hundred and fifty patients with subacute LBP. METHODS: Patients were assigned randomly to a 10-week individual-based multimodal program of task-oriented exercises integrated with cognitive-behavioral therapy (experimental group, 75 patients) or individual-based general physiotherapy (control group, 75 patients). Before treatment, 10 weeks later (post-treatment), and 12 months after treatment, the staff administered the Oswestry Disability Index (ODI, primary outcome), a pain intensity numerical rating scale (NRS), the Tampa Scale for Kinesiophobia (TSK), the Pain Beliefs and Perception Inventory (PBAPI), the Hospital and Anxiety Depression Score (HADS) and the Coping Strategies Questionnaire-revised (CSQ-R). Linear mixed model analysis for repeated measures was carried out for each outcome measure. RESULTS: Significant group (P<0.001), time (P=0.002), and time-by-group interaction (P<0.001) effects were found for ODI, with a between-group difference (standard error) after training of 11.5 (1.0) and at follow-up of 15.7 (0.9), in favor of the experimental group. A significant interaction effect (P<0.001) was found for all secondary outcome measures, with significantly greater improvements in the experimental group, after rehabilitation and at follow-up. CONCLUSIONS: The multidisciplinary intervention was superior to general physiotherapy in reducing disability, pain, psychological factors and coping strategies of patients with subacute LBP. The effects were reinforced after one year. CLINICAL REHABILITATION IMPACT: Treatment of subacute LBP requires cognitive modifications closely linked to physical performances in order to achieve mental adjustments and guarantee cognitive-behavioral and motor lasting changes.

A Robotic System with EMG-Triggered Functional Eletrical Stimulation for Restoring Arm Functions in Stroke Survivors.

BACKGROUND: Robotic systems combined with Functional Electrical Stimulation (FES) showed promising results on upper-limb motor recovery after stroke, but adequately-sized randomized controlled trials (RCTs) are still missing. OBJECTIVE: To evaluate whether arm training supported by RETRAINER, a passive exoskeleton integrated with electromyograph-triggered functional electrical stimulation, is superior to advanced conventional therapy (ACT) of equal intensity in the recovery of arm functions, dexterity, strength, activities of daily living, and quality of life after stroke. METHODS: A single-blind RCT recruiting 72 patients was conducted. Patients, randomly allocated to 2 groups, were trained for 9 weeks, 3 times per week: the experimental group performed task-oriented exercises assisted by RETRAINER for 30 minutes plus ACT (60 minutes), whereas the control group performed only ACT (90 minutes). Patients were assessed before, soon after, and 1 month after the end of the intervention. Outcome measures were as follows: Action Research Arm Test (ARAT), Motricity Index, Motor Activity Log, Box and Blocks Test (BBT), Stroke Specific Quality of Life Scale (SSQoL), and Muscle Research Council. RESULTS: All outcomes but SSQoL significantly improved over time in both groups (P < .001); a significant interaction effect in favor of the experimental group was found for ARAT and BBT. ARAT showed a between-group change of 11.5 points (P = .010) at the end of the intervention, which increased to 13.6 points 1 month after. Patients considered RETRAINER moderately usable (System Usability Score of 61.5 ± 22.8). CONCLUSIONS: Hybrid robotic systems, allowing to perform personalized, intensive, and task-oriented training, with an enriched sensory feedback, was superior to ACT in improving arm functions and dexterity after stroke.

Does cycling induced by functional electrical stimulation enhance motor recovery in the subacute phase after stroke? A systematic review and meta-analysis.

OBJECTIVE: To investigate the effects of cycling with functional electrical stimulation on walking, muscle power and tone, balance and activities of daily living in subacute stroke survivors. DATA SOURCES: Ten electronic databases were searched from inception to February 2020. REVIEW METHODS: Inclusion criteria were: subacute stroke survivors (<6 months since stroke), an experimental group performing any type of cycling training with electrical stimulation, alone or in addition to usual care, and a control group performing usual care alone. Two reviewers assessed eligibility, extracted data and analyzed the risks of bias. Standardized Mean Difference (SMD) or Mean Difference (MD) with 95% Confidence Intervals (CI) were estimated using fixed- or random-effects models to evaluate the training effect. RESULTS: Seven randomized controlled trials recruiting a total of 273 stroke survivors were included in the meta-analyses. There was a statistically significant, but not clinically relevant, effect of cycling with electrical stimulation compared to usual care on walking (six studies, SMD [95% CI] = 0.40 [0.13, 0.67]; P = 0.004), capability to maintain a sitting position (three studies, MD [95% CI] = 7.92 [1.01, 14.82]; P = 0.02) and work produced by the paretic leg during pedaling (2 studies, MD [95% CI] = 8.13 [1.03, 15.25]; P = 0.02). No significant between-group differences were found for muscular power, tone, standing balance, and activities of daily living. CONCLUSIONS: Cycling training with functional electrical stimulation cannot be recommended in terms of being better than usual care in subacute stroke survivors. Further investigations are required to confirm these results, to determine the optimal training parameters and to evaluate long-term effects.

Changes in leg cycling muscle synergies after training augmented by functional electrical stimulation in subacute stroke survivors: a pilot study.

BACKGROUND: Muscle synergies analysis can provide a deep understanding of motor impairment after stroke and of changes after rehabilitation. In this study, the neuro-mechanical analysis of leg cycling was used to longitudinally investigate the motor recovery process coupled with cycling training augmented by Functional Electrical Stimulation (FES) in subacute stroke survivors. METHODS: Subjects with ischemic subacute stroke participated in a 3-week training of FES-cycling with visual biofeedback plus usual care. Participants were evaluated before and after the intervention through clinical scales, gait spatio-temporal parameters derived from an instrumented mat, and a voluntary pedaling test. Biomechanical metrics (work produced by the two legs, mechanical effectiveness and symmetry indexes) and bilateral electromyography from 9 leg muscles were acquired during the voluntary pedaling test. To extract muscles synergies, the Weighted Nonnegative Matrix Factorization algorithm was applied to the normalized EMG envelopes. Synergy complexity was measured by the number of synergies required to explain more than 90% of the total variance of the normalized EMG envelopes and variance accounted for by one synergy. Regardless the inter-subject differences in the number of extracted synergies, 4 synergies were extracted from each patient and the cosine-similarity between patients and healthy weight vectors was computed. RESULTS: Nine patients (median age of 75 years and median time post-stroke of 2 weeks) were recruited. Significant improvements in terms of clinical scales, gait parameters and work produced by the affected leg were obtained after training. Synergy complexity well correlated to the level of motor impairment at baseline, but it did not change after training. We found a significant improvement in the similarity of the synergy responsible of the knee flexion during the pulling phase of the pedaling cycle, which was the mostly compromised at baseline. This improvement may indicate the re-learning of a more physiological motor strategy. CONCLUSIONS: Our findings support the use of the neuro-mechanical analysis of cycling as a method to assess motor recovery after stroke, mainly in an early phase, when gait evaluation is not yet possible. The improvement in the modular coordination of pedaling correlated with the improvement in motor functions and walking ability achieved at the end of the intervention support the role of FES-cycling in enhancing motor re-learning after stroke but need to be confirmed in a controlled study with a larger sample size. TRIAL REGISTRATION: ClinicalTrial.gov, NCT02439515. Registered on May 8, 2015, .

A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial.

BACKGROUND: Early interventions maximizing patient's involvement are essential to promote gait restoration and motor recovery after stroke. AIM: The aim of this study is to evaluate the effects of a multimodal biofeedback training involving cycling augmented by functional electrical stimulation (FES) and balance exercises on walking ability and motor recovery. DESIGN: Randomized controlled trial (NCT02439515). SETTING: Inpatient rehabilitation facility. POPULATION: Subacute stroke survivors (less than 6 months from the first event) aged up to 90 years old. METHODS: Sixty-eight participants were randomly allocated to an experimental group, performing 15 sessions of biofeedback FES-cycling training followed by 15 sessions of biofeedback balance training (20 minutes each) in addition to usual care (70 minutes), and a control group performing 30 sessions (90 minutes) of usual care. Participants were evaluated before training, after 15 sessions, after 30 sessions, and at 6-month follow-up through: gait speed (primary outcome), spatiotemporal gait parameters, Six-Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale. RESULTS: Both groups significantly improved over time, but no group and interaction effects were found for any outcomes. The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (P=0.048). These percentages were even more unbalanced for patients with a moderate to severe gait impairment at baseline (91% versus 36%; P=0.008). CONCLUSIONS: The multimodal biofeedback training was not statistically superior to usual care, showing only a positive trend in favor of the experimental group on locomotion recovery. Patients initially not able to walk might be the best candidates for such a training. CLINICAL REHABILITATION IMPACT: The multimodal biofeedback training is a task-specific, repetitive and intensive training requiring a minimal supervision, which might result in a lower staff to patient ratio if organized in group sessions. Therefore, it can represent a good alternative for early stroke rehabilitation.