Action Observation Treatment for Upper Limb Rehabilitation in Patients With Stroke: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: In the last few years, new noninvasive strategies have emerged as rehabilitative treatments for patients with stroke. Action observation treatment (AOT) is a rehabilitation approach based on the properties of the mirror neuron system with a positive impact on modifying cortical activation patterns and improving the upper limb kinematics. AOT involves the dynamic process of observing purposeful actions with the intention of imitating and then practicing those actions. In recent years, several clinical studies suggested the effectiveness of AOT in patients with stroke to improve motor recovery and autonomy in activities of daily living. However, a deeper knowledge of the behavior of the sensorimotor cortex during AOT seems to be essential. OBJECTIVE: The aim of this clinical trial, conducted in 2 neurorehabilitation centers and in patients' homes, is to investigate the effectiveness of AOT in patients with stroke, confirming the translational power of a tailored treatment. Particular emphasis will be placed on the predictive value of neurophysiological biomarkers. In addition, the feasibility and impact of a home-based AOT program will be investigated. METHODS: A 3-arm, assessor-blinded, randomized controlled trial will be performed by enrolling patients with stroke in the chronic stage. A total of 60 participants will be randomly allocated to receive 15 sessions of AOT with different protocols (AOT at the hospital, AOT at home, and sham AOT), 3 sessions per week. The primary outcome will be assessed using the Fugl-Meyer Assessment-Upper Extremity scores. Secondary outcomes will be clinical, biomechanical, and neurophysiological assessment. RESULTS: The study protocol is part of a project (project code GR-2016-02361678) approved and funded by the Italian Ministry of Health. The study began with the recruitment phase in January 2022, and enrollment was expected to end in October 2022. Recruitment is now closed (December 2022). The results of this study are expected to be published in spring 2023. Upon completion of the analyses, we will examine the preliminary effectiveness of the intervention and neurophysiological outcomes. CONCLUSIONS: This study will be used to evaluate the effectiveness of 2 different AOT scenarios (ie, AOT at the hospital and AOT at home) in patients with chronic stroke and to assess the predictive value of neurophysiological biomarkers. Specifically, we will attempt to induce the functional modification of the cortical components by exploiting the features of the mirror neuron system, demonstrating relevant clinical, kinematic, and neurophysiological changes after AOT. With our study, we also want to provide, for the first time in Italy, the AOT home-based program while assessing its feasibility and impact. TRIAL REGISTRATION: ClinicalTrials.gov NCT04047134; https://clinicaltrials.gov/ct2/show/NCT04047134. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42094.

The Reaching Phase of Feeding and Self-Care Actions Optimizes Action Observation Effects in Chronic Stroke Subjects.

BACKGROUND: The Action Observation Therapy (AOT) is a well-established post-stroke rehabilitation treatment based on the theoretical framework of the Mirror Neuron System (MNS) activation. However, AOT protocols are still heterogeneous in terms of video contents of observed actions. OBJECTIVE: The aim of this study was to analyze electroencephalographic (EEG) recordings in stroke patients during the observation of different videos of task-specific upper limb movements, and to define which category of actions can elicit a stronger cortical activation in the observer's brain. METHODS: Signals were analyzed from 19 chronic stroke subjects observing customized videos that represented 3 different categories of upper limb actions: Finalized Actions, Non-Finalized Actions, and Control Videos. The Event-Related Desynchronization in the µ and ß bands was chosen to identify the involvement of the cerebral cortex: the area of the normalized power spectral density was calculated for each category and, deepening, for the reaching and completion sub-phases of Finalized Actions. For descriptive purposes, the time course of averaged signal power was described. The Kruskal-Wallis test (P < .05) was applied. RESULTS: The analysis showed a greater desynchronization when subjects observed Finalized Actions with respect to Non-Finalized in all recorded areas; Control videos provoked a synchronization in the same areas and frequency bands. The reaching phase of feeding and self-care actions evoked a greater suppression both in µ and ß bands. CONCLUSIONS: The observation of finalized arm movements seems to elicit the strongest activation of the MNS in chronic stroke patients. This finding may help the clinicians to design future AOT-based stroke rehabilitation protocols. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT04047134.

Kinematic Analysis of Exoskeleton-Assisted Community Ambulation: An Observational Study in Outdoor Real-Life Scenarios.

(1) Background: In neurorehabilitation, Wearable Powered Exoskeletons (WPEs) enable intensive gait training even in individuals who are unable to maintain an upright position. The importance of WPEs is not only related to their impact on walking recovery, but also to the possibility of using them as assistive technology; however, WPE-assisted community ambulation has rarely been studied in terms of walking performance in real-life scenarios. (2) Methods: This study proposes the integration of an Inertial Measurement Unit (IMU) system to analyze gait kinematics during real-life outdoor scenarios (regular, irregular terrains, and slopes) by comparing the ecological gait (no-WPE condition) and WPE-assisted gait in five able-bodied volunteers. The temporal parameters of gait and joint angles were calculated from data collected by a network of seven IMUs. (3) Results: The results showed that the WPE-assisted gait had less knee flexion in the stance phase and greater hip flexion in the swing phase. The different scenarios did not change the human-exoskeleton interaction: only the low-speed WPE-assisted gait was characterized by a longer double support phase. (4) Conclusions: The proposed IMU-based gait assessment protocol enabled quantification of the human-exoskeleton interaction in terms of gait kinematics and paved the way for the study of WPE-assisted community ambulation in stroke patients.

The role of resilience and coping among Italian healthcare workers during the COVID-19 pandemic.

OBJECTIVE: To evaluate the psychological state of healthcare workers (HCWs) in the field of rehabilitation during the COVID-19 pandemic. METHODS: Cross-sectional observational study. Sample of 334 HCWs including: nurses, medical doctors, therapists, scientists, and clerical workers working at the IRCCS San Raffaele Roma rehabilitation hospital during the second wave of the COVID-19 pandemic. Anonymous web-based questionnaire included 14-item Resilience Scale, Brief-COPE, Hospital Anxiety Depression Scale, Fear of COVID-19 Scale. Occupational and sociodemographic characteristics. RESULTS: High levels of resilience, low levels of anxiety, depression, and fear were observed in the study population; the most frequently used coping strategies in the Brief-COPE were acceptance, planning, and active coping. Specifically, 87% of the participants reported a moderate to high level of resilience, with the highest level observed in nurses while physicians show the lowest level. HCWs showed symptoms of anxiety (29%), depressive symptoms (10%), and fear caused by the COVID-19 pandemic (44%). Statistically significant differences were observed between different occupations for fear (p <0.05) and resilience (p <0.01). Levels of anxiety and fear appeared to be higher in female and younger workers. The latter group - who also reported higher levels of depression - showed lower levels of resilience. CONCLUSIONS: In our study hospital and non-hospital workers show different emotional, cognitive, and behavioural resources when facing stressful situations, like in the case of the SARS-CoV-2 pandemics. Our results support the role of resilience and the proper use of problem-focused and emotion-focused coping strategies as protective factors from psychological distress.

Sensor Network for Analyzing Upper Body Strategies in Parkinson's Disease versus Normative Kinematic Patterns.

In rehabilitation, the upper limb function is generally assessed using clinical scales and functional motor tests. Although the Box and Block Test (BBT) is commonly used for its simplicity and ease of execution, it does not provide a quantitative measure of movement quality. This study proposes the integration of an ecological Inertial Measurement Units (IMUs) system for analysis of the upper body kinematics during the execution of a targeted version of BBT, by able-bodied persons with subjects with Parkinson's disease (PD). Joint angle parameters (mean angle and range of execution) and hand trajectory kinematic indices (mean velocity, mean acceleration, and dimensionless jerk) were calculated from the data acquired by a network of seven IMUs. The sensors were applied on the trunk, head, and upper limb in order to characterize the motor strategy used during the execution of BBT. Statistics revealed significant differences (p < 0.05) between the two groups, showing compensatory strategies in subjects with PD. The proposed IMU-based targeted BBT protocol allows to assess the upper limb function during manual dexterity tasks and could be used in the future for assessing the efficacy of rehabilitative treatments.

Functional Gait Recovery after a Combination of Conventional Therapy and Overground Robot-Assisted Gait Training Is Not Associated with Significant Changes in Muscle Activation Pattern: An EMG Preliminary Study on Subjects Subacute Post Stroke.

BACKGROUND: Overground Robot-Assisted Gait Training (o-RAGT) appears to be a promising stroke rehabilitation in terms of clinical outcomes. The literature on surface ElectroMyoGraphy (sEMG) assessment in o-RAGT is limited. This paper aimed to assess muscle activation patterns with sEMG in subjects subacute post stroke after training with o-RAGT and conventional therapy. METHODS: An observational preliminary study was carried out with subjects subacute post stroke who received 15 sessions of o-RAGT (5 sessions/week; 60 min) in combination with conventional therapy. The subjects were assessed with both clinical and instrumental evaluations. Gait kinematics and sEMG data were acquired before (T1) and after (T2) the period of treatment (during ecological gait), and during the first session of o-RAGT (o-RAGT1). An eight-channel wireless sEMG device acquired in sEMG signals. Significant differences in sEMG outcomes were found in the BS of TA between T1 and T2. There were no other significant correlations between the sEMG outcomes and the clinical results between T1 and T2. CONCLUSIONS: There were significant functional gains in gait after complex intensive clinical rehabilitation with o-RAGT and conventional therapy. In addition, there was a significant increase in bilateral symmetry of the Tibialis Anterior muscles. At this stage of the signals from the tibialis anterior (TA), gastrocnemius medialis (GM), rectus femoris (RF), and biceps femoris caput longus (BF) muscles of each lower extremity. sEMG data processing extracted the Bilateral Symmetry (BS), the Co-Contraction (CC), and the Root Mean Square (RMS) coefficients. RESULTS: Eight of 22 subjects in the subacute stage post stroke agreed to participate in this sEMG study. This subsample demonstrated a significant improvement in the motricity index of the affected lower limb and functional ambulation. The heterogeneity of the subjects' characteristics and the small number of subjects was associated with high variability research, functional gait recovery was associated with minimal change in muscle activation patterns.

Barriers to sEMG Assessment During Overground Robot-Assisted Gait Training in Subacute Stroke Patients.

Background: The limitation to the use of ElectroMyoGraphy (sEMG) in rehabilitation services is in contrast with its potential diagnostic capacity for rational planning and monitoring of the rehabilitation treatments, especially the overground Robot-Assisted Gait Training (o-RAGT). Objective: To assess the barriers to the implementation of a sEMG-based assessment protocol in a clinical context for evaluating the effects of o-RAGT in subacute stroke patients. Methods: An observational study was conducted in a rehabilitation hospital. The primary outcome was the success rate of the implementation of the sEMG-based assessment. The number of dropouts and the motivations have been registered. A detailed report on difficulties in implementing the sEMG protocol has been edited for each patient. The educational level and the working status of the staff have been registered. Each member of staff completed a brief survey indicating their level of knowledge of sEMG, using a five-point Likert scale. Results: The sEMG protocol was carried out by a multidisciplinary team composed of Physical Therapists (PTs) and Biomedical Engineers (BEs). Indeed, the educational level and the expertise of the members of staff influenced the fulfillment of the implementation of the study. The PTs involved in the study did not receive any formal education on sEMG during their course of study. The low success rate (22.7%) of the protocol was caused by several factors which could be grouped in: patient-related barriers; cultural barriers; technical barriers; and administrative barriers. Conclusions: Since a series of barriers limited the use of sEMG in the clinical rehabilitative environment, concrete actions are needed for disseminating sEMG in rehabilitation services. The sEMG assessment should be included in health systems regulations and specific education should be part of the rehabilitation professionals' curriculum. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03395717.

Acceptance and Potential Impact of the eWALL Platform for Health Monitoring and Promotion in Persons with a Chronic Disease or Age-Related Impairment.

Pervasive health technologies can increase the effectiveness of personal health monitoring and training, but more user studies are necessary to understand the interest for these technologies, and how they should be designed and implemented. In the present study, we evaluated eWALL, a user-centered pervasive health technology consisting of a platform that monitors users' physical and cognitive behavior, providing feedback and motivation via an easy-to-use, touch-based user interface. The eWALL was placed for one month in the home of 48 subjects with a chronic condition (chronic obstructive pulmonary disease-COPD or mild cognitive impairment-MCI) or with an age-related impairment. User acceptance, platform use, and potential clinical effects were evaluated using surveys, data logs, and clinical scales. Although some features of the platform need to be improved before reaching technical maturity and making a difference in patients' lives, the real-life evaluation of eWALL has shown how some features may influence patients' intention to use this promising technology. Furthermore, this study made it clear how the free use of different health apps is modulated by the real needs of the patient and by their usefulness in the context of the patient's clinical status.

P-hacking in clinical trials and how incentives shape the distribution of results across phases.

Clinical research should conform to high standards of ethical and scientific integrity, given that human lives are at stake. However, economic incentives can generate conflicts of interest for investigators, who may be inclined to withhold unfavorable results or even tamper with data in order to achieve desired outcomes. To shed light on the integrity of clinical trial results, this paper systematically analyzes the distribution of P values of primary outcomes for phase II and phase III drug trials reported to the ClinicalTrials.gov registry. First, we detect no bunching of results just above the classical 5% threshold for statistical significance. Second, a density-discontinuity test reveals an upward jump at the 5% threshold for phase III results by small industry sponsors. Third, we document a larger fraction of significant results in phase III compared to phase II. Linking trials across phases, we find that early favorable results increase the likelihood of continuing into the next phase. Once we take into account this selective continuation, we can explain almost completely the excess of significant results in phase III for trials conducted by large industry sponsors. For small industry sponsors, instead, part of the excess remains unexplained.