Effects of Upper Limb Robot-Assisted Rehabilitation Compared with Conventional Therapy in Patients with Stroke: Preliminary Results on a Daily Task Assessed Using Motion Analysis.

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.

Back Pain in Adolescents: Characteristics, Quality of Life, and Drug Self-Management: A Cross-Sectional Study of 1301 Italian Students.

OBJECTIVES: Back pain is one of the major problems for the public health system in the western world. The purposes of this study were to assess back pain in a large cohort of adolescents; to evaluate the prevalence, intensity, and features; and obtain information about drug management of this symptom. METHODS: One thousand four hundred seventy-one healthy students aged 14 to 19 years were enrolled in the study. The subjects underwent a face-to-face interview using an ad hoc questionnaire, the Numeric Rating Scale, the Neuropathic Pain Symptom Inventory, and the Short-Form 36 questionnaire. RESULTS: Sixty-eight percent of adolescents reported moderate to severe pain, with a higher prevalence of moderate/severe pain in female. The intensity of pain was higher (P < 0.001) in females than in men. A correlation was found between pain and quality of life. Considering the adolescents with severe pain, 21.6% requested a doctor's opinion, and 18% used analgesics (63.2% of them without a doctor's prescription), with a frequency of about 2 times per month. CONCLUSIONS: We found that the prevalence of back pain in adolescents is very high, with the consequences on quality of life, and it becomes frequently a self-managed symptom. This should encourage research on the causes of pain in order to limit the risk factors underlying the pain development and obtain a good prevention strategy.

Estimation of Human Center of Mass Position through the Inertial Sensors-Based Methods in Postural Tasks: An Accuracy Evaluation.

The estimation of the body's center of mass (CoM) trajectory is typically obtained using force platforms, or optoelectronic systems (OS), bounding the assessment inside a laboratory setting. The use of magneto-inertial measurement units (MIMUs) allows for more ecological evaluations, and previous studies proposed methods based on either a single sensor or a sensors' network. In this study, we compared the accuracy of two methods based on MIMUs. Body CoM was estimated during six postural tasks performed by 15 healthy subjects, using data collected by a single sensor on the pelvis (Strapdown Integration Method, SDI), and seven sensors on the pelvis and lower limbs (Biomechanical Model, BM). The accuracy of the two methods was compared in terms of RMSE and estimation of posturographic parameters, using an OS as reference. The RMSE of the SDI was lower in tasks with little or no oscillations, while the BM outperformed in tasks with greater CoM displacement. Moreover, higher correlation coefficients were obtained between the posturographic parameters obtained with the BM and the OS. Our findings showed that the estimation of CoM displacement based on MIMU was reasonably accurate, and the use of the inertial sensors network methods should be preferred to estimate the kinematic parameters.

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial.

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).

Reliability, validity and discriminant ability of a robotic device for finger training in patients with subacute stroke.

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.

BDNF rs6265 Polymorphism and Its Methylation in Patients with Stroke Undergoing Rehabilitation.

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 (χ2(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.

Prediction of Falls in Subjects Suffering From Parkinson Disease, Multiple Sclerosis, and Stroke.

OBJECTIVE: To compare the risk of falls and fall predictors in patients with Parkinson disease (PD), multiple sclerosis (MS), and stroke using the same study design. DESIGN: Multicenter prospective cohort study. SETTING: Institutions for physical therapy and rehabilitation. PARTICIPANTS: Patients (N=299) with PD (n=94), MS (n=111), and stroke (n=94) seen for rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Functional scales were applied to investigate balance, disability, daily performance, self-confidence with balance, and social integration. Patients were followed for 6 months. Telephone interviews were organized at 2, 4, and 6 months to record falls and fall-related injuries. Incidence ratios, Kaplan-Meier survival curves, and Cox proportional hazards models were used. RESULTS: Of the 299 patients enrolled, 259 had complete follow-up. One hundred and twenty-two patients (47.1%) fell at least once; 82 (31.7%) were recurrent fallers and 44 (17.0%) suffered injuries; and 16%, 32%, and 40% fell at 2, 4, and 6 months. Risk of falls was associated with disease type (PD, MS, and stroke in decreasing order) and confidence with balance (Activities-specific Balance Confidence [ABC] scale). Recurrent fallers were 7%, 15%, and 24% at 2, 4, and 6 months. The risk of recurrent falls was associated with disease type, high educational level, and ABC score. Injured fallers were 3%, 8%, and 12% at 2, 4, and 6 months. The only predictor of falls with injuries was disease type (PD). CONCLUSIONS: PD, MS, and stroke carry a high risk of falls. Other predictors include perceived balance confidence and high educational level.

Reliability, validity and discriminant ability of the instrumental indices provided by a novel planar robotic device for upper limb rehabilitation.

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 .

Does First Ray Amputation in Diabetic Patients Influence Gait and Quality of Life?

It has recently been suggested that first ray amputation in diabetic patients with serious foot complications can prolong bipedal ambulatory status, and reduce morbidity and mortality. However, no data are available on gait analysis and quality of life after this procedure. In the present case-control study (6 amputee and 6 nonamputee diabetics, 6 healthy non-diabetic), a sample of amputee diabetic patients were evaluated and compared with a sample of nonamputee diabetic patients and a group of age-matched healthy subjects. Gait biomechanics, quality of life, and pain were evaluated. Compared with the other 2 groups, amputee patients displayed a lower walking speed and greater variability and lower ankle, knee, and hip range of motion values. They also tended to have a more flexed hip profile. Pain and lower quality of life were related to worsening biomechanical data. Our study results have shown that gait biomechanics in diabetic patients with first ray amputation are abnormal, probably owing to the severity of diabetes and the absence of the push-off phase provided by the hallux. Tailored orthotics and rehabilitation programs and a specific pain management program should be considered to improve the gait and quality of life of diabetic patients with first ray amputation.

An exploratory study of BDNF and oxidative stress marker alterations in subacute and chronic stroke patients affected by neuropathic pain.

Patients affected by stroke, particularly subacute stroke patients, often complain of neuropathic pain (NP), which may severely impair their quality of life. The aim of this exploratory study was to characterize NP and to investigate whether there is a correlation between NP and serum brain-derived neurotrophic factor (BDNF) and serum markers of oxidative stress. We enrolled 50 patients divided in subacute (< 90 days from stroke onset) and chronic (> 90 and 180 < days from stroke onset). The Barthel Index, Deambulation Index, and Short Form 36 were used to assess the patients' degree of disability and quality of life. Pain-specific tools, namely the Numeric Rating Scale (NRS), Neuropathic Pain Diagnostic questionnaire (DN4), and Neuropathic Pain Symptom Inventory (NPSI), were also used. Serum levels of BDNF and markers of oxidative stress and of metal status were evaluated: copper, iron, transferrin, ferritin, ceruloplasmin concentration (iCp) and activity (eCp), Total Antioxidant status (TAS), Cp/Tf ratio, eCp/iCp ratio, and non-ceruloplasmin bound copper (Non-Cp Cu). We found the highest value of BDNF in subacute with NP (DN4 score ≥ 4). The TAS, Cp/Tf ratio, and eCp/iCp not only fell outside the normal reference range in a high percentage of subacute and chronic patients, but were also found to be related to specific NP symptoms. These preliminary results reveal altered BDNF and oxidative stress indices in subacute stroke patients who complain of NP. These investigative findings may shed more light on the mechanisms underlying NP and consequently lead to a more tailored therapeutic and/or rehabilitation procedure of subacute stroke patients.

Muscle focal vibration in healthy subjects: evaluation of the effects on upper limb motor performance measured using a robotic device.

PURPOSE: Muscle vibration is a technique that applies a low-amplitude/high-frequency vibratory stimulus to a specific muscle using a mechanical device. The aim of this study was to evaluate, using robot-based outcomes, the effects of focal muscle vibration, at different frequencies, on the motor performance of the upper limb in healthy subjects. METHODS: Forty-eight volunteer healthy subjects (age: 31 ± 8 years) were enrolled. Subjects were assigned to three different groups: the first group, in which subjects underwent muscle vibration treatment with a frequency of 100 Hz; the second group of subjects underwent the same treatment protocol, but using a frequency of vibration of 200 Hz; finally, the control group did not undergo any treatment. The robot-based evaluation session consisted of visually guided reaching task, performed in the sagittal plane. RESULTS: Our results showed that the vibration treatment improved upper limb motor performance of healthy subjects from the baseline (T0) to 10 days after the end of the treatment (T2), but only the group treated with a frequency of 200 Hz reached statistical significance. Specifically, in this group we found an increase of the number of repetitions (T0: 51.4 ± 22.7; T2: 66.3 ± 11.8), and the smoothness of the movement, as showed by a decrease of the Normalized Jerk (T0: 10.5 ± 2.8; T2: 7.7 ± 0.5). CONCLUSION: The results of our study support the use of focal muscle vibration protocols in healthy subjects, to improve motor performance.

Occurrence and predictors of the fatigue in high-grade glioma patients.

A better knowledge of the fatigue could be of the greatest importance for the high-grade glioma (HGG) patients, who are a unique and vulnerable population. The aim of this study was to evaluate the occurrence and the predictors of the fatigue in HGG patients, using a specific fatigue scale. The study was designed as a cross-sectional study. The study population included sixty-seven consecutive outpatients with HGG. We used these measures: Brief Fatigue Inventory, Karnofsky Performance Scale, Functional Independence Measure, Brief Psychiatric Rating Scale and Psychological Distress Inventory and SF-36, EORTC QLQ-30 and EORTC QLQ-BN20 for quality of life (QoL). Sixteen out of sixty-seven (23.9 %) patients were affected by Anaplastic Astrocytoma and 51/67 (76.1 %) by Glioblastoma Multiforme. About one-third (36.2 %) of patients had a clinically relevant fatigue (Brief Fatigue Inventory ≥3). In regression analysis, physical and mental aspects of QoL were statistically significant related with fatigue (p < 0.01 and p < 0.02, respectively). Our data underlined the relevant occurrence of fatigue in HGG patients and support the development of further studies exploring a tailored rehabilitation program.

Implementation of a robot-mediated upper limb rehabilitation protocol for a customized treatment after stroke: A retrospective analysis.

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.

Muscle quality improvement in subacute post-stroke patients after rehabilitation: Usefulness of segmental phase angle from bioelectrical impedance analysis.

BACKGROUND & AIMS: During stroke rehabilitation, the whole-body Phase Angle (PhA) from Bioelectrical Impedance Analysis (BIA) is measured to assess whole-body muscle quality, which reflects cellular integrity and function. The segmental BIA is a valuable method for assessing the body composition of specific body segments, such as the arms, legs, and hemisoma. After a stroke insult, patients frequently experience hemiparesis, and segmental PhA from segmental BIA appears to be an appropriate parameter for examining the muscle quality of affected and unaffected limbs separately. This study aims to investigate whether segmental PhA is more informative than whole-body PhA in (a) assessing the deterioration of muscle quality in post-stroke patients and (b) monitoring its recovery following rehabilitative treatment. METHODS: This longitudinal study recruited subacute post-stroke patients who were admitted to our rehabilitation center. At admission, demographic, anamnestic, and clinical information, such as the presence of comorbidities, were recorded. BIA was used to evaluate the whole-body PhA and segmental PhA of the affected and unaffected hemisoma, arms, and legs at admission (T0) and after a six-week rehabilitation program (T1). The modified Barthel Index (mBI), Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), and Motricity Index of the Upper (MI-UE) and Lower (MI-LE) Extremities were evaluated at T0 and T1 to determine the patient's Activity of Daily Living (ADL) performance, upper limb motor performance, and upper and lower limb muscle strength, respectively. RESULTS: We evaluated segmental and whole-body BIA in 70 subacute post-stroke patients (women n = 34, ischemic n = 56, mean age 70 ± 11) at T0 and T1. Whole-body PhA values of the patients were below the normal range. Considering segmental data, the affected hemisoma, arm, and leg had considerably lower PhA values as compared to the unaffected body segments. Furthermore, at T1, the PhA values of all affected body segments improved, while those of the unaffected ones and whole-body PhA did not. At both T0 and T1, the segmental PhA values of the affected body segments showed to be related with all clinical outcome measures, while whole-body PhA correlated only with mBI. CONCLUSIONS: This study emphasizes the significance of measuring segmental PhA in hemiparetic subacute stroke patients undergoing rehabilitation treatment. Segmental PhA is a more accurate parameter to evaluate rehabilitation treatment in patients with hemiparesis because it can distinguish affected from unaffected body segments, hence facilitating accurate monitoring of muscle quality improvements resulting from a rehabilitation program.

Efficacy of telerehabilitation with digital and robotic tools for the continuity of care of people with chronic neurological disorders: The TELENEURO@REHAB protocol for a randomized controlled trial.

Context: Chronic Neurological Disorders (CNDs) are among the leading causes of disability worldwide, and their contribution to the overall need for rehabilitation is increasing. Therefore, the identification of new digital solutions to ensure early and continuous care is mandatory. Objective: This protocol proposes to test the usability, acceptability, safety, and efficacy of Telerehabilitation (TR) protocols with digital and robotic tools in reducing the perceived level of disability in CNDs including Parkinson's Disease (PD), Multiple Sclerosis (MS), and post-stroke patients. Design Setting and Subjects: This single-blinded, multi-site, randomized, two-treatment arms controlled clinical trial will involve PD (N = 30), MS (N = 30), and post-stroke (N = 30). Each participant will be randomized (1:1) to the experimental group (20 sessions of motor telerehabilitation with digital and robotic tools) or the active control group (20 home-based motor rehabilitation sessions according to the usual care treatment). Primary and secondary outcome measures will be obtained at the baseline (T0), post-intervention (T1, 5 weeks after baseline), and at follow-up (T2, 2 months after treatment). Main Outcome Measures: a multifaceted evaluation including quality of life, motor, and clinical/functional measures will be conducted at each time-point of assessment. The primary outcome measures will be the change in the perceived level of disability as measured by the World Health Organization Disability Assessment Schedule 2.0. Conclusion: The implementation of TR protocols will enable a more targeted and effective response to the growing need for rehabilitation linked to CNDs, ensuring accessibility to rehabilitation services from the initial stages of the disease.

Systemic Oxidative Stress in Subacute Stroke Patients Undergoing Rehabilitation Treatment.

The imbalance in oxidative stress in acute stroke has been extensively studied; on the contrary, its investigation in the subacute phase is limited. The aim of this study was to analyse the variation in the systemic oxidative status in subacute post-stroke patients before (T0) and after a six-week rehabilitation treatment (T1) and to investigate the relationship between systemic oxidative status and rehabilitation outcomes. We enrolled 109 subjects in two different centres, and we analysed their serum hydroperoxide levels (d-ROMs), biological antioxidant power (BAP), thiol antioxidant components (-SHp), and relative antioxidant capacity (OSI and SH-OSI indices). Activity of Daily Living (ADL), hand grip strength, and walking endurance were evaluated using the modified Barthel Index, the Hand Grip test, and the 6-min walk test, respectively. At T0, most of the patients showed very high levels of d-ROMs and suboptimal levels of the BAP, OSI, and SH-OSI indices. Comparing the T1 and T0 data, we observed an improvement in the rehabilitation outcomes and a significant decrease in d-ROMs (549 ± 126 vs. 523 ± 148, p = 0.023), as well as an improvement in the OSI and SH-OSI indices (4.3 ± 1.3 vs. 4.7 ± 1.5, p = 0.001; 11.0 ± 0.4 vs. 1.2 ± 0.4, p < 0.001). In addition, significant correlations were seen between the oxidative stress parameters and the rehabilitation outcomes. These results suggest monitoring the systemic oxidative stress status in post-stroke patients in order to plan a tailored intervention, considering its relationship with functional recovery.

Comprehensive Observational and Longitudinal study on the Outbreak of Stroke-related Spasticity focusing on the Early Onset management with Botulinum NeuroToxin (COLOSSEO-BoNT): protocol for a real-world prospective observational study on upper limb spasticity.

INTRODUCTION: Poststroke spasticity (PSS) affects up to 40% of patients who had a stroke. Botulinum neurotoxin type A (BoNT-A) has been shown to improve spasticity, but the optimal timing of its application remains unclear. While several predictors of upper limb PSS are known, their utility in clinical practice in relation to BoNT-A treatment has yet to be fully elucidated. The COLOSSEO-BoNT study aims to investigate predictors of PSS and the effects of BoNT-A timing on spasticity-related metrics in a real-world setting. METHODS AND ANALYSIS: The recruitment will involve approximately 960 patients who have recently experienced an ischaemic stroke (within 10 days, V0) and will follow them up for 24 months. Parameters will be gathered at specific intervals: (V1) 4, (V2) 8, (V3) 12, (V4) 18 months and (V5) 24 months following enrolment. Patients will be monitored throughout their rehabilitation and outpatient clinic journeys and will be compared based on their BoNT-A treatment status-distinguishing between patients receiving treatment at different timings and those who undergo rehabilitation without treatment. Potential predictors will encompass the Fugl-Meyer assessment, the National Institute of Health Stroke Scale (NIHSS), stroke radiological characteristics, performance status, therapies and access to patient care pathways. Outcomes will evaluate muscle stiffness using the modified Ashworth scale and passive range of motion, along with measures of quality of life, pain, and functionality. ETHICS AND DISSEMINATION: This study underwent review and approval by the Ethics Committee of the Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy. Regardless of the outcome, the findings will be disseminated through publication in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05379413.

Nutrition in Post-Stroke Subjects during Rehabilitation.

Correct and appropriate nutrition after a stroke insult appears to exert an essential influence on, and play a key role in, the recovery of patients [...].