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Background: Many authors have emphasized the need for individualized treatments in rehabilitation, but no tailored robotic rehabilitation protocol for stroke patients has been established yet., Objective: To evaluate the effectiveness of a robot-mediated upper limb rehabilitation protocol based on clinical assessment for customized treatment of stroke patients., Methods: Clinical data from 81 patients with subacute stroke, undergoing an upper limb robot-mediated rehabilitation, were analyzed retrospectively. 49 patients were treated using a customized robotic protocol (experimental group, EG) based on a clinically guided flowchart, while 32 were treated without it (control group, CG). Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Motricity Index (MI), modified Barthel Index (mBI) and Numerical Rating Scale (NRS) measured before (T0) and after (T1) rehabilitation intervention were used as clinical outcomes., Results: There was statistically significant improvement in both groups in terms of FMA-UE, MI, and mBI, while no change in NRS. Intergroup analysis showed significantly greater improvement of the FMA-UE (P = 0.002) and MI (P < 0.001) in the EG, compared with the CG., Conclusion: The implementation of our robotic protocol for customized treatment of stroke patients yielded greater recovery in upper limb motor function and strength over robotic treatment without a defined protocol.

Bilateral robotic rehabilitation has proven helpful in the recovery of upper limb motor function in patients with stroke, but its effects on the cortical reorganization mechanisms underlying recovery are still unclear. This pilot Randomized Controlled Trial (RCT) aimed to evaluate the effects on the interhemispheric balance of unilateral or bilateral robotic treatments in patients with subacute stroke, using Quantitative Electroencephalography (qEEG). 19 patients with ischemic stroke underwent a 30-session upper limb neurorehabilitation intervention using a bilateral upper limb exoskeleton. Each patient was randomly assigned to the bilateral (BG, n=10) or unilateral treatment group (UG, n=9). EEG evaluations were performed before (T0) and right after (T [Formula: see text] the first treatment session, after 30 treatment sessions (T1), and at 1-week follow-up (T2), in both eyes open and eyes closed conditions. From the acquired EEG data, the pairwise-derived Brain Symmetry Index (pdBSI) was computed. In addition, clinical evaluation was performed at T0 and T1 with validated clinical scales. After the treatment, a significant improvement in clinical and EEG evaluations was observed for both groups, but only the BG showed reduced pdBSI in delta and theta bands. In the cluster of sensorimotor channels, there was no significant difference between groups. The observed changes were not maintained at follow-up. No significant changes were observed in the pdBSI after a single rehabilitation session. Results suggest that balancing of interhemispheric symmetry comes along with a clinical improvement in the upper extremity and that the pdBSI can be used to investigate the mechanisms of neuronal plasticity involved in robotic rehabilitation after stroke.

Clinicians often deal with complex robotic platform and serious games in stroke patients rehabilitation contexts, and they face two main problems: 1) the interpretation of either the performance in game or measures of a robotic system from the motor recovery point of view, and 2) the duration and complexity of clinical scales administration that makes repetitive assessments during the therapy unpractical. In this paper, a Random Tree Forest based system was trained and tested to provide a prediction of different clinical outcomes (i.e. FMA, ARAT, and MI) along the whole therapy duration, having non-clinical measures only as inputs, acting as a simulated decision support system. The dataset includes 30 post-stroke patients, that underwent a 30-session robot-assisted rehabilitation treatment. Results have shown that the system is able to produce very accurate and reliable predictions about the motor recovery of the patient at the end of the therapy, already in the first phases of the rehabilitation (i40% of therapy execution), just using robotic platform measures. Such a tool would provide a great benefit in terms of rehabilitation objectives planning, as a decision support tool for highly personalized rehabilitation treatments.

Robotic rehabilitation of the upper limb has demonstrated promising results in terms of the improvement of arm function in post-stroke patients. The current literature suggests that robot-assisted therapy (RAT) is comparable to traditional approaches when clinical scales are used as outcome measures. Instead, the effects of RAT on the capacity to execute a daily life task with the affected upper limb are unknown, as measured using kinematic indices. Through kinematic analysis of a drinking task, we examined the improvement in upper limb performance between patients following a robotic or conventional 30-session rehabilitation intervention. In particular, we analyzed data from nineteen patients with subacute stroke (less than six months following stroke), nine of whom treated with a set of four robotic and sensor-based devices and ten with a traditional approach. According to our findings, the patients increased their movement efficiency and smoothness regardless of the rehabilitative approach. After the treatment (either robotic or conventional), no differences were found in terms of movement accuracy, planning, speed, or spatial posture. This research seems to demonstrate that the two investigated approaches have a comparable impact and may give insight into the design of rehabilitation therapy.

After a stroke, patients can suffer from sarcopenia, which can affect recovery. This could be closely related to an impairment in nutritional status. In this preliminary analysis of a longitudinal prospective study, we screened 110 subjects admitted to our rehabilitation center after a stroke. We then enrolled 61 patients, who underwent a 6-week course of rehabilitation treatment. We identified a group of 18 sarcopenic patients (SG), according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), by evaluating muscle strength with the handgrip test, and muscle mass with bioelectrical impedance analysis (BIA). With respect to the non-sarcopenic group (NSG), the SG at admission (T0) had worse muscle quality, according to the BIA-derived phase angle, and a lower score of MNA®-SF. In contrast to the NSG, the SG also exhibited lower values for both BMI and the Geriatric Nutritional Risk Index (GNRI) at T0 and T1. Moreover, 33% of the SG had a major risk of nutrition-related complications (GNRI at T0 < 92) and discarded on average more food during the six weeks of rehabilitation (about one-third of the average daily plate waste). Of note is the fact that the Barthel Index’s change from baseline indicated that the SG had a worse functional recovery than the NGS. These results suggest that an accurate diagnosis of sarcopenia, along with a proper evaluation of the nutritional status on admission to rehabilitation centers, appears strictly necessary to design individual, targeted physical and nutritional intervention for post-stroke patients, to improve their ability outcomes.

The use of quantitative methods to analyze the loss in gait smoothness, an increase in movement intermittency which is a distinguishing hallmark of motor deficits in stroke patients, has gained considerable attention in recent years. In the literature, the spectral arc length (SPARC), as well as metrics based on the measurement of the jerk, such as the log dimensionless jerk (LDLJ), are currently employed to assess smoothness. However, the optimal measure for evaluating the smoothness of walking in stroke patients remains unknown. Here, we investigated the smoothness of the body's center of mass (BCoM) trajectory during gait, using an optoelectronic system, in twenty-two subacute and eight chronic patients before and after a two-month rehabilitation program. The two measures were evaluated for their discriminant validity (ability to differentiate the smoothness of the BCoM trajectory calculated on the cycle of the affected and unaffected limb, and between subacute and chronic patients), validity (correlation with clinical scales), and responsiveness to the intervention. According to our findings, the LDLJ outperformed the SPARC in terms of the examined qualities. Based on data gathered using an optoelectronic system, we recommend using the LDLJ rather than the SPARC to investigate the gait smoothness of stroke patients.

Robotic-based rehabilitation administered by means of serious games certainly represents the frontier of rehabilitation treatments, offering a high degree of customization of therapy, to meet individual patients' needs and to tailor a proper rehabilitation therapy. Despite the rush on developing complex rehabilitation systems, they often do not provide clinicians with long-term information about the outcome of rehabilitation, thus, not supporting them in the initial set-up phase of the therapy. In this paper, a Random-Forest based system was trained and tested to provide a prediction at discharge of several clinical scales outcomes (i.e. FMA, ARAT, and MI), having clinical scale scores and measures from the robotic system at the enrollment as inputs. The dataset includes 25 post-stroke patients from different clinics, that underwent a variable number of days of rehabilitation with a robotic treatment. Results have shown that the system is able to predict the final outcome with an accuracy ranging from 60% to 73% on the selected scales. Also results provide information on which variables are more relevant for the prediction of outcome of therapy, in particular clinical scales scores such as FMA, ARAT, MI, NRS, PCS, and MCS and robotic automatically extracted measurements related to patient's work expenditure and time. This supports the idea of using such a system in a clinical environment in a decision support tool for clinicians.

The state of the art is still lacking an extensive analysis of which clinical characteristics are leading to better outcomes after robot-assisted rehabilitation on post-stroke patients. Prognostic machine learning-based models could promote the identification of predictive factors and be exploited as Clinical Decision Support Systems (CDSS). For this reason, the aim of this work was to set the first steps toward the development of a CDSS, by the development of machine learning models for the functional outcome prediction of post-stroke patients after upper-limb robotic rehabilitation. Four different regression algorithms were trained and cross-validated using a nested 5×10-fold cross-validation. The performances of each model on the test set were provided through the Median Average Error (MAE) and interquartile range. Additionally, interpretability analyses were performed, to evaluate the contribution of the features to the prediction. The results on the two best performing models showed a MAE of 13.6 [13.4] and 13.3 [14.8] on the Modified Barthel Index score (MBI). The interpretability analyses highlighted the Fugl-Meyer Assessment, MBI, and age as the most relevant features for the prediction of the outcome. This work showed promising results in terms of outcome prognosis after robot-assisted treatment. Further research should be planned for the development, validation and translation into clinical practice of CDSS in rehabilitation. Clinical relevance- This work establishes the premises for the development of data-driven tools able to support the clinical decision for the selection and optimisation of the robotic rehabilitation treatment.

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

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

Background and Aims: Poststroke shoulder pain is a common complication. We aimed to investigate the prevalence of poststroke shoulder pain, with attention to the neuropathic component, and the relationship between poststroke shoulder pain and upper limb improvement in motor function, strength, disability, and quality of life after upper limb rehabilitation., Methods: This is a secondary analysis of a multicenter randomized controlled trial to compare upper limb conventional or robotic rehabilitation on 224 patients enrolled in eight rehabilitation centers. We assessed poststroke shoulder pain (using the Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0), after 30 rehabilitation sessions (T1), and three months after the end of rehabilitation (T2)., Results: A moderate/severe poststroke shoulder pain was reported by 28.9% of patients, while 19.6% of them showed a neuropathic component. At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life.Moderate/severe pain and neuropathic component significantly reduced after both treatments and this reduction was maintained at T2. Finally, the intensity of pain at baseline was negatively correlated with the improvement of upper limb motor function., Conclusions: Poststroke shoulder pain negatively impact on motor performance, strength, disability, and physical aspects of the quality of life as well as on upper limb motor recovery; however, it can be reduced after a robotic or a conventional rehabilitation. Therefore, we suggest considering poststroke shoulder pain when planning the rehabilitation intervention.

Recently it has been suggested that serotonin transporter ( SLC6A4 ) and its 5HTTLPR polymorphism could be involved in post stroke recovery. Here, we characterized the methylation profile of two different CpG islands within the SLC6A4 promoter region in the whole blood of 50 patients with subacute stroke before and after a six-week rehabilitation treatment. These patients were genotyped for 5HTTLPR polymorphism identifying patients on the basis of short (S) and L (L) alleles: 17 patients LL, 22 patients LS and 11 patients SS. At baseline, all CpG sites for both CpG islands displayed a heterogeneous methylation percentage that were not influenced by the different genotypes. After rehabilitation, we found a significant variation in the methylation levels (increase/decrease) in the specific CpG sites of both CpG islands. The statistical analysis showed a significant relationship between the LL, LS and SS alleles and the outcome of the rehabilitation intervention ( χ 2 (2,50) = 6.395, p = 0.041). Specifically, we found a significant difference between patients with or without a favorable outcome in the LL (11.1% with a favorable outcome) and in the SS (54.4% with a favorable outcome) groups. Our data suggest that 5-HTTLPR polymorphisms and SLC6A4 promoter methylation may be employed as a non-invasive biological marker of recovery in patients with stroke undergoing rehabilitation.

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

Background: There is consistent evidence that robotic rehabilitation is at least as effective as conventional physiotherapy for upper extremity (UE) recovery after stroke, suggesting to focus research on which subgroups of patients may better respond to either intervention. In this study, we evaluated which baseline variables are associated with the response after the two approaches., Methods: This is a secondary analysis of a randomized-controlled trial comparing robotic and conventional treatment for the UE. After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment. Variables associated with the response were identified in a univariate analysis. Then, variables independently associated with recovery were investigated, in the whole group, and the two groups separately., Results: A sample of 190 patients was evaluated after the treatment; 121 were responders. Age, baseline impairment, and neglect were significantly associated with worse response to the treatment. Age was the only independently associated variable (OR 0.967, p = 0.023). Considering separately the two interventions, age remained negatively associated with recovery (OR 0.948, p = 0.013) in the conventional group, while none of the variables previously identified were significantly associated with the response to treatment in the robotic group., Conclusions: We found that, in our sample, age is significantly associated with the outcome after conventional but not robotic UE rehabilitation. Possible explanations may include an enhanced positive attitude of the older patients towards technological training and reduced age-associated fatigue provided by robotic-assisted exercise. The possibly higher challenge proposed by robotic training, unbiased by the negative stereotypes concerning very old patients' expectations and chances to recover, may also explain our findings., Trial Registration Number: NCT02879279.

Background: To standardize assessment and coordinate processes in stroke rehabilitation, an integrated care pathway (ICP) was developed in an Italian Rehabilitation and Research Institution by a knowledge-translation interdisciplinary process, from evidence-based guidelines to rehabilitation practice. The ICP was implemented in two pilot Tuscan rehabilitation Centers., Aim: The purpose of this study was to describe ICP development and assess the ICP effects on postacute stroke inpatient rehabilitation outcomes., Design: Prospective observational study, before and after comparison., Setting: Two Tuscan inpatient rehabilitation centers., Population: Patients accessing either centers for intensive rehabilitation after acute stroke., Methods: Two cohorts were prospectively recruited before (2015-2017) and after (2018) implementation of the pathway. The primary outcome was change in activities of daily living disability, assessed by the modified Barthel Index (mBI) from admission to discharge. Secondary outcomes included length of stay (LOS), adverse outcomes, and changes in communication ability, trunk control, pain, ambulation, bladder catheter (Y/N), bedsores (Y/N)., Results: In 2015-2017, 443 postacute stroke patients (mean age 77±11 years, 47% women), while in 2018, 84 patients (mean age 76±13 years, 61% women) were admitted to the two facilities. Comparing the 2018 vs. the 2015-17 cohort, the mean mBI increase was not substantially different (26 vs. 24 points), nor were LOS (37±18 vs. 36±16 days), adverse outcomes, discharge destination, and improvement of ambulation, pain, and communication (P>0.05). Instead, a significantly higher improvement of trunk control (trunk control test: 69.6±33.2 vs. 79.0±31.3, P=0.019), and a higher percentage of bedsore resolution (13% vs. 5%, P=0.033), and bladder catheter removal (37% vs. 17% P<0.001) were observed in 2018 vs. 2015-2017., Conclusions: Compared to prior practice, ICP was associated to improvement of trunk control recovery, bladder catheter removal, and bedsores resolution. Further ICP implementation on a larger scale is needed to verify improvements of stroke inpatient rehabilitation outcomes., Clinical Rehabilitation Impact: An evidence-based stroke rehabilitation ICP was interdisciplinary developed and implemented in two rehabilitation centers of a multicenter Italian health group. ICP implementation as to inpatient intensive postacute stroke rehabilitation was associated to improved trunk control recovery, bladder catheter removal, and bedsore resolution. Further ICP implementation will allow multicenter studies and quality benchmarking.

Brain-Derived Neurotrophic Factor (BDNF) and its rs6265 single nucleotide polymorphism (SNP) play an important role in post-stroke recovery. We investigated the correlation between BDNF rs6265 SNP and recovery outcome, measured by the modified Barthel index, in 49 patients with stroke hospitalized in our rehabilitation center at baseline (T0) and after 30 sessions of rehabilitation treatment (T1); moreover, we analyzed the methylation level of the CpG site created or abolished into BDNF rs6265 SNP. In total, 11 patients (22.4%) were heterozygous GA, and 32 (65.3%) and 6 (12.2%) patients were homozygous GG and AA, respectively. The univariate analysis showed a significant relationship between the BDNF rs6265 SNP and the modified Barthel index cut-off (χ 2 (1, N = 48) = 3.86, p = 0.049), considering patients divided for carrying (A+) or not carrying (A-) the A allele. A higher percentage of A- patients obtained a favorable outcome, as showed by the logistic regression model corrected by age and time since the stroke onset, compared with the A+ patients (OR: 5.59). At baseline (T0), the percentage of BDNF methylation was significantly different between GG (44.6 ± 1.1%), GA (39.5 ± 2.8%) and AA (28.5 ± 1.7%) alleles ( p < 0.001). After rehabilitation (T1), only patients A- showed a significant increase in methylation percentages (mean change = 1.3, CI: 0.4-2.2, p = 0.007). This preliminary study deserves more investigation to confirm if BDNF rs6265 SNP and its methylation could be used as a biological marker of recovery in patients with stroke undergoing rehabilitation treatment.

Upper limb recovery is a complex process and a strong challenge in the rehabilitation of patients after stroke. Several studies have been conducted to compare the efficacy of conventional and robotic rehabilitation to restore the upper limb motor impairment following a stroke. However, the evolution of the upper limb motor ability during an intervention, as well as the time point when the patient stops improving (the so call plateau), are rarely measured, and never compared between the two approaches. These latter aspects are very important considering the need for an optimization of the economic resources. In this study, the time course of the upper limb motor recovery of 24 subacute stroke patients undergoing a 30-session robotic or conventional treatment was analyzed through the upper extremity portion of the Fugl-Meyer Assessment scale (FMA-UE). The FMA-UE was administered before the treatment, and after 10, 20, and 30 rehabilitation sessions. Statistical analysis showed that, according to the FMA-UE, the time course in the two groups was similar: patients did not change between the baseline and the 10-session assessment, while they improved between 10 and 20 sessions, and between 20 and 30 sessions, with most of the gain observed between 10 and 20 sessions. This result suggests that 30-session robotic or conventional rehabilitation programs induce a similar curve trend in the upper limb motor recovery of patients with subacute stroke, with an important increase in the middle of the program and without reaching a clear plateau in the analyzed time interval., (Copyright 2020 Biolife Sas. www.biolifesas.org.)

Background and Purpose: Rehabilitation plays a central role in stroke recovery. Besides conventional therapy, technological treatments have become available. The effectiveness and appropriateness of technological rehabilitation are not yet well defined; hence, research focused on different variables impacting recovery is needed. Results from the literature identified cognitive reserve (CR) as a variable impacting on the cognitive outcome. In this paper, the aim was to evaluate whether CR influences the motor outcome in patients after stroke treated with conventional or robotic therapy and whether it may influence one treatment rather than another., Methods: Seventy-five stroke patients were enrolled in five Italian neurological rehabilitation centres. Patients were assigned either to a robotic group, rehabilitation by means of robotic devices, or to a conventional group, where a traditional approach was used. Patients were evaluated at baseline and after rehabilitation treatment of 6 weeks through the Action Research Arm Test (ARAT), the Motricity Index (MI) and the Barthel Index (BI). CR was assessed at baseline using the Cognitive Reserve Index (CRI) questionnaire., Results: Considering all patients, a weak correlation was found between the CRI related to leisure time and MI evolution (r = 0.276; P = 0.02). Amongst the patients who performed a robotic rehabilitation, a moderate correlation emerged between the CRI related to working activities and MI evolution (r = 0.422; P = 0.02)., Conclusions: Our results suggest that CR may influence the motor outcome. For each patient, CR and its subcategories should be considered in the choice between conventional and robotic treatment., (© 2019 European Academy of Neurology.)

Background: The majority of stroke survivors experiences significant hand impairments, as weakness and spasticity, with a severe impact on the activity of daily living. To objectively evaluate hand deficits, quantitative measures are needed. The aim of this study is to assess the reliability, the validity and the discriminant ability of the instrumental measures provided by a robotic device for hand rehabilitation, in a sample of patients with subacute stroke., Material and Methods: In this study, 120 patients with stroke and 40 controls were enrolled. Clinical evaluation included finger flexion and extension strength (using the Medical Research Council, MRC), finger spasticity (using the Modified Ashworth Scale, MAS) and motor control and dexterity during ADL performance (by means of the Frenchay Arm Test, FAT). Robotic evaluations included finger flexion and extension strength, muscle tone at rest, and instrumented MAS and Modified Tardieu Scale. Subjects were evaluated twice, one day apart, to assess the test-retest reliability of the robotic measures, using the Intraclass Correlation Coefficient (ICC). To estimate the response stability, the standard errors of measurement and the minimum detectable change (MDC) were also calculated. Validity was assessed by analyzing the correlations between the robotic metrics and the clinical scales, using the Spearman's Correlation Coefficient (r). Finally, we investigated the ability of the robotic measures to distinguish between patients with stroke and healthy subjects, by means of Mann-Whitney U tests., Results: All the investigated measures were able to discriminate patients with stroke from healthy subjects (p < 0.001). Test-retest reliability was found to be excellent for finger strength (in both flexion and extension) and muscle tone, with ICCs higher than 0.9. MDCs were equal to 10.6 N for finger flexion, 3.4 N for finger extension, and 14.3 N for muscle tone. Conversely, test-retest reliability of the spasticity measures was poor. Finally, finger strength (in both flexion and extension) was correlated with the clinical scales (r of about 0.7 with MRC, and about 0.5 with FAT)., Discussion: Finger strength (in both flexion and extension) and muscle tone, as provided by a robotic device for hand rehabilitation, are reliable and sensitive measures. Moreover, finger strength is strongly correlated with clinical scales. Changes higher than the obtained MDC in these robotic measures could be considered as clinically relevant and used to assess the effect of a rehabilitation treatment in patients with subacute stroke.

Background and Purpose: After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy., Methods: In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation., Results: One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference -0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences., Discussion and Conclusions: Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).

Background: End-effector robots allow intensive gait training in stroke subjects and promote a successful rehabilitation. A comparison between conventional and end-effector Robot-Assisted Gait Training (RAGT) in subacute stroke patients is needed., Objective: To investigate the efficacy of end-effector RAGT in subacute stroke patients., Methods: Twenty-six subacute stroke patients were divided into two group: 14 patients performed RAGT (RG); 12 patients performed conventional gait training (CG). Clinical assessment and gait analysis were performed at the beginning (T0) and at the end (T1) of the rehabilitation., Results: The RG revealed a significant improvement in body function, activities, participation scales, and in the distance measured with the 6 MWT. The affected lower limb's spasticity significantly decreased at T1. In gait analysis, RG showed significantly increases in many parameters. The CG significantly improved clinical assessments but showed no significant changes in gait parameters. Statistically significant differences between RG and CG were found in MRC-HE, TCT, 10 MWT, 6 MWT, and TUG. No significant difference between groups was registered in gait kinematics., Conclusions: Both rehabilitation treatments produce promising effects in subacute stroke patients. RAGT device offers a more intensive, controlled, and physiological gait training and significantly improved deambulation.

Robotic and sensor-based neurologic rehabilitation for the upper limb is an established concept for motor learning and is recommended in many national guidelines. The complexity of the human hands and arms and the different activities of daily living are leading to an approach in which robotic and sensor-based devices are used in combination to fulfill the multiple requirements of this intervention. A multidisciplinary team of the Fondazione Don Carlo Gnocchi (FDG), an Italian nonprofit foundation, which spans across the entire Italian territory with 28 rehabilitation centers, developed a strategy for the implementation of robotic rehabilitation within the FDG centers. Using an ad hoc form developed by the team, 4 robotic and sensor-based devices were identified among the robotic therapy devices commercially available to treat the upper limb in a more comprehensive way (from the shoulder to the hand). Encouraging results from a pilot study, which compared this robotic approach with a conventional treatment, led to the deployment of the same set of robotic devices in 8 other FDG centers to start a multicenter randomized controlled trial. Efficiency and economic factors are just as important as clinical outcome. The comparison showed that robotic group therapy costs less than half per session in Germany than standard individual arm therapy with equivalent outcomes. To ensure access to high-quality therapy to the largest possible patient group and lower health care costs, robot-assisted group training is a likely option., (Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.)

Background: In the last few years, there has been an increasing interest in the use of robotic devices to objectively quantify motor performance of patients after brain damage. Although these robot-derived measures can potentially add meaningful information about the patient's dexterity, as well as be used as outcome measurements after the rehabilitation treatment, they need to be validated before being used in clinical practice. The present work aims to evaluate the reliability, the validity and the discriminant ability of the metrics provided by a novel robotic device for upper limb rehabilitation., Methods: Forty-eight patients with sub-acute stroke and 40 age-matched healthy subjects were involved in this study. Clinical evaluation included: Fugl-Meyer Assessment for the upper limb, Action Research Arm Test, and Barthel Index. Robotic evaluation of the upper limb performance consisted of 14 measures of motor ability quantifying the dexterity in performing planar reaching movements. Patients were evaluated twice, one day apart, to assess the reliability of the robotic metrics, using the Intraclass Correlation Coefficient. Validity was assessed by analyzing the correlation of the robotic metrics with the clinical scales, by means of the Spearman's Correlation Coefficient. Finally, the ability of the robotic metrics to distinguish between patients with stroke and healthy subjects was investigated with t-tests and the Effect Size., Results: Reliability was found to be excellent for 12 measures and from moderate to good for the remaining 2. Most of the robotic indices were strongly correlated with the clinical scales, while a few showed a moderate correlation and only one was not correlated with the Barthel Index and weakly correlated with the remain two. Finally, all but one the provided metrics were able to discriminate between the two groups, with large effect sizes for most of them., Conclusion: We found that all the robotic indices except one provided by a novel robotic device for upper limb rehabilitation are reliable, sensitive and strongly correlated both with motor and disability clinical scales. Therefore, this device is suitable as evaluation tool for the upper limb motor performance of patients with sub-acute stroke in clinical practice., Trial Registration: NCT02879279 .

Purpose: Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible., Study Design: Multicenter randomized controlled trial., Methods: Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire., Results: Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size., Conclusion: This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Background: The gait recovery is a realist goal in the rehabilitation of almost Stroke patients. Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has had a greatest interest., Objective: The aim of this study was to evaluate efficacy of Robotic Gait Training (RGT) in chronic stroke patients., Methods: Fourteen chronic stroke patients were divided into two groups. Six patients received RGT, eight patients received traditional gait rehabilitation. Patients were assessed with clinical scales, as well as with gait analysis, at the beginning and at the end of the treatment., Results: Significant changes in some clinical scales for both the groups were detected. In the robotic group, patients showed higher percentage changes in the MRC scale (p = 0.020), in the 6MWT (p = 0.043) and in the Ashworth scale (hip: p = 0.008; knee: p = 0.043; ankle: p = 0.043) when compared with the traditional group. With respect to the gait analysis, we did not found any difference neither in the within-group analysis, nor in the between-group analysis., Conclusions: Both rehabilitation treatments do not change the compensatory strategies in chronic patients but the RGT offers to the patients a more intensive and controlled gait training increasing the gait endurance and decreasing spasticity in the lower limb.

Background: Post-stroke pain (PSP) is a common and disabling complication, difficult to treat, that often decreases patients' quality of life (QoL). The hypothesis is that PSP may negatively affect rehabilitation treatment., Aim: The aim of this paper was to quantify and characterize pain in a sample of post-stroke patients undergoing rehabilitation and to investigate the impact of pain in slowing down or discontinuing the rehabilitation program., Design: Multicenter cross-sectional study., Setting: Inpatients and outpatients of rehabilitation department., Population: One hundred and six subacute and chronic stroke patients., Methods: Pain intensity was measured with the NRS or the PAINAD (if cognitive/language impairment was present); pain characteristics were assessed with the DN4, and NPSI questionnaire. Qol was measured with the SF-36. A clinical assessment and a semi-structured questionnaire on pain occurrence, impact, and management was administered by the physiotherapist in charge of the patients and by the physician., Results: Nearly 1/3 of the patients (32.9%) with normal cognitive functions and language reported pain occurrence after stroke; 81.8% of them had NRS≥3 and 31.8% DN4≥4 (meaning neuropathic origin of pain). In about 20% of the patients the PAINAD was used to measure pain; 17.4% of them presented a score ≥3. In 24.5% of our sample, pain influenced rehabilitation treatment. In 16% of the whole sample, pain influenced patients' attention during rehabilitation session. Patients with hypoesthesia presented significantly higher neuropathic pain scores than patients with normal sensory function. Regarding QoL, we found that patients with higher neuropathic pain showed more severe deterioration of mental aspects of QoL, where patients with higher nociceptive pain presented more severe deterioration of physical aspects of QoL., Conclusion: The results from this multicenter study showed that in about ¼ of the patients, pain negatively influenced the rehabilitation program delaying the recovery and likely increasing the cost of rehabilitation., Clinical Rehabilitation Impact: Clinicians should pay more attention to pain, especially neuropathic pain, in post-stroke patients. Tailored pharmacological therapy, to treat and prevent pain, might improve patients' compliance during the rehabilitation process.

Advanced rehabilitation strategies of the upper limb in stroke patients focus on the recovery of the most important daily activities. In this study we analyzed quantitatively and qualitatively the motor strategies employed by stroke patients when reaching and drinking from a glass. We enrolled 6 hemiparetic poststroke patients and 6 healthy subjects. Motion analysis of the task proposed (reaching for the glass, bringing it to the mouth, and putting it back on the table) with the affected limb was performed. Clinical assessment using the Fugl-Meyer Assessment for Upper Extremity was also included. During the reaching for the glass the patients showed a reduced arm elongation and trunk axial rotation due to motor deficit. For this reason, as observed, they carried out compensatory strategies which included trunk forward displacement and head movements. These preliminary data should be considered to address rehabilitation treatment. Moreover, the kinematic analysis protocol developed might represent an outcome measure of upper limb rehabilitation processes.

Aim: The aim of this study was to describe the baseline characteristics of a sample of stroke patients admitted to rehabilitation settings with the use of a standardised stroke assessment named ''Protocollo di Minima per l'ictus cerebrale'' (PMIC), to verify the usefulness of the application of PMIC and to compare the data of the authors with the international literature., Methods: An observational cross sectional study was conducted on a sample of 102 first-time stroke patients (mean age: 71.9 [+/-11.6], 54 men), in three inpatient rehabilitation centres., Measurement: PMIC., Results: Most patients were enrolled within 14 days of stroke onset. PMIC assessment took on average 20 minutes and provided the following information: 35% had architectural barriers in their homes; 82% of the cases had 1 or more family assistants; the educational level was low for 53%; 72% were retired; most cases were ischemic stroke without any side predominance being shown; 44% had partial anterior circulation infarcts (PACI) ischemic stroke; 18.6% presented dysphagia; 73% had sphincteral incontinence; there was no hypertone in more than 50% of the cases; 87% required assistance; the median Motricity Index Side Score (Miss) value was 44.1; 38% was affected by mood tone alteration., Conclusion: PMIC appeared to be a useful tool for a standardized evaluation of stroke patients. These results provide data with a high correspondence in international reports.

Primary Objective: To evaluate the effects of rehabilitation on disability and quality of life (QoL) in patients with chronic stroke., Research Design: This is an observational, prospective and multidimensional study., Methods and Procedures: Sixty-six consecutive inpatients were enrolled. A rehabilitation programme of 2 months consisting of six exercise periods per week was performed. An impairment of cognitive function was the exclusion criteria for patient enrolment., Main Outcomes and Results: European Stroke Scale, Barthel Index, Modified Rankin Scale, Deambulation Index and SF-36 were performed both before and after rehabilitation. A short-term follow-up (2 months after discharge) was performed by phone administration of SF-36. Significant improvement in clinical and disability measurements was observed after rehabilitation. For QoL, a significant improvement was observed both in physical function and in social function immediately after rehabilitation. At follow-up the social function improvement was maintained, while physical function improvement was lost., Conclusions: The data show that rehabilitation in patients with chronic stroke lessens disability and improves physical and social function and that repeated cycles of treatment are needed to maintain the level of improvement reached.

The purposes of this study were: (1) to evaluate the relationship between disability and Quality of Life (QoL) in stroke outpatients undergoing rehabilitation and (2) to determine whether and how demographic and social features of the patient, duration of disease and concomitant diseases influence the disability and QoL of the stroke outpatients. We performed a prospective study using several conventional disability measurements (Barthel Index, Functional Independence Measure, Modified Rankin Scale and Deambulation Index) and a validated patient-oriented measurement of QoL (SF-36). Sixty-eight outpatients were evaluated consecutively. As expected, all disability measurements were related to Physical Function: patients with higher disability, according to the physician's perspective, complained of higher deterioration of physical performance. Unexpectedly, patients with higher disability from the physician's point of view perceive that they were not able to do some daily activities not only because of physical problems but also because of emotional problems, and complained of higher deterioration of mental health. Multivariate analysis showed that higher disability is associated with higher age, depression and lower educational level. Physical Composite Score appeared to be deteriorated in patients with lower educational level who lived with family; on the contrary, Mental Composite Score appeared deteriorated in patients with higher educational level who lived alone. The current study provides interesting data about the relationship, not always expected, between disability and QoL for stroke patients and about the influence of patients' characteristics on disability and QoL. Our results showed that in a rehabilitation programme we should consider not only disability assessment but also QoL, which is more relevant for the patient.