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.

Turning and sit-to-walk measures from the instrumented Timed Up and Go test return valid and responsive measures of dynamic balance in Parkinson's disease.

BACKGROUND: Balance impairment is a hallmark of Parkinson's disease with dramatic effects for patients (e.g. falls). Its assessment is thus of paramount importance. The aim of this work is to assess which measures from the instrumented Timed Up and Go test (recorded with inertial sensors) are valid balance measures in Parkinson's disease and evaluate their responsiveness to rehabilitation. METHODS: The Mini-BESTest (a criterion-standard balance measure) and the instrumented Timed Up and Go test (with inertial sensors secured to the trunk) were administered to 20 Parkinson's disease patients before and after inpatient rehabilitation (median [IQR]; 76.5 [8.25] years; 5 females; Hoehn and Yahr stage: 2.5 [0.5]). 81 parameters from the instrumented Timed Up and Go test were evaluated. Multiple factor analysis (a variant of principal component analysis for repeated measurements) and effect sizes were used to assess validity and responsiveness, respectively. FINDINGS: Only the first component of the multiple factor analysis correlated with the Mini-BESTest, and 21 measures from the instrumented Timed Up and Go test had large loadings on this component. However, only three of these 21 measures also directly correlated with the Mini-BESTest (trunk angular velocities from sit-to-walk and turning; r = 0.46 to 0.50, P = 0.021 to 0.038). Sit-to-walk angular velocity showed greater responsiveness than the Mini-BESTest, while turning showed slightly less. INTERPRETATION: Angular velocities from the turning and sit-to-walk phases of the Timed Up and Go test are valid balance measures in Parkinson's disease and are also responsive to rehabilitation.

Bringing spatiotemporal gait analysis into clinical practice: Instrument validation and pilot study of a commercial sensorized carpet.

BACKGROUND AND OBJECTIVE: We illustrate a low-cost platform easing the estimation of spatio-temporal parameters (GA-STP) ready for large-scale deployment in fall prevention. METHODS: We used a commercial sensorized carpet with a limited cost and a very coarse resolution. An instrument validation test was accomplished: the Wilcoxon test for paired samples and the correlation test with Spearman method were used to compare the values computed by the platform with reference ones. Hierarchical clustering using Ward's method and ROC curves have been used to assess the performance in a pilot study enrolling patients. RESULTS: Validation shows no significant difference between computed and reference values of gait speed (ρ-value:0.99; p-value:2.2E-16), step number (ρ-value:0.91; p-value:5.8E-16) and stride-length (ρ-value:0.92; p-value:7.5E-9). The clinical pilot study confirms that the platform may also be used to track the improvements occurring during a rehabilitation program. CONCLUSIONS: We believe that the use of a commercial carpet makes the solution proposed ready to be deployed on a large scale for effectively bringing GA into the clinical practice.

A Novel Virtual Coaching System Based on Personalized Clinical Pathways for Rehabilitation of Older Adults-Requirements and Implementation Plan of the vCare Project.

Home-based rehabilitation after an acute episode or following an exacerbation of a chronic disease is often problematic with a clear lack of continuity of care between hospital and home care. Secondary prevention is an essential element of long-term rehabilitation where strategies oriented toward risk reduction, treatment adherence, and optimization of quality of life need to be applied. Frail and sometimes isolated, the patient fails to adhere to the proposed post-discharge clinical pathway due to lack of appropriate clinical, emotional, and informational support. Providing a suitable rehabilitation after an acute episode or a chronic disease is a major issue, as it helps people to live independently and enhance their quality of life. However, as the rehabilitation period usually lasts some months, the continuity of care is often interrupted in the transition from hospital to home. Virtual coaches could help these patients to engage in a personalized rehabilitation program that complies with age-related conditions. These coaches could be a key technology for empowering patients toward increasing their adherence to the care plan and to improve their secondary prevention measures. In this paper, we are presenting a novel virtual coaching system that will address these challenges by combining recent technological advances with clinical pathways, based on joint research and validation activities from researchers from the medical and information and communication technology (ICT) domains.

Rehabilitation, the Great Absentee of Virtual Coaching in Medical Care: Scoping Review.

BACKGROUND: In the last few years, several studies have focused on describing and understanding how virtual coaches (ie, coaching program or smart device aiming to provide coaching support through a variety of application contexts) could be key drivers for health promotion in home care settings. As there has been enormous technological progress in the field of artificial intelligence and data processing in the past decade, the use of virtual coaches gains an augmented attention in the considerations of medical innovations. OBJECTIVE: This scoping review aimed at providing an overview of the applications of a virtual coach in the clinical field. In particular, the review focused on the papers that provide tangible information for coaching activities with an active implication for engaging and guiding patients who have an ongoing plan of care. METHODS: We aimed to investigate the use of the term virtual coach in the clinical field performing a methodical review of the relevant literature indexed on PubMed, Scopus, and Embase databases to find virtual coach papers focused on specific activities dealing with clinical or medical contexts, excluding those aimed at surgical settings or electronic learning purposes. RESULTS: After a careful revision of the inclusion and exclusion criteria, 46 records were selected for the full-text review. Most of the identified articles directly or indirectly addressed the topic of physical activity. Some papers were focused on the use of virtual coaching (VC) to manage overweight or nutritional issues. Other papers dealt with technological interfaces to facilitate interactions with patients suffering from different chronic clinical conditions such as heart failure, chronic obstructive pulmonary disease, depression, and chronic pain. CONCLUSIONS: Although physical activity is a healthy practice that is most encouraged by a virtual coach system, in the current scenario, rehabilitation is the great absentee. This paper gives an overview of the tangible applications of this tool in the medical field and may inspire new ideas for future research on VC.

Responsiveness to rehabilitation of balance and gait impairment in elderly with peripheral neuropathy.

Elderly people with peripheral neuropathy of the lower limbs (PNLL) demonstrate a typical balance and gait impairment because of sensory ataxia. There is evidence that rehabilitation produces important gains on balance and gait. However, responsiveness to rehabilitation of balance and gait measures is unknown in PNLL. Aim of the current work is to evaluate the responsiveness to rehabilitation of balance, gait and sensory ataxia measures in elderly with PNLL. Twenty-five elderly with PNLL attending physiotherapy and occupational therapy during inpatient rehabilitation were recruited. Balance and gait measures (including static posturography, TUG test and the 10 m walking test) were administered on admission and discharge. An accelerometer secured to the trunk was used for TUG recording and static balance assessment. Static balance was tested with open and closed eyes, so as to assess sensory ataxia. Following rehabilitation, patients improved gait [admission vs discharge, mean(SD): 0.86(0.33) vs 0.98(0.32) m/s], TUG [18.7(7.8) vs 15.1(5.2) s] and turning [46.2(15.3) vs 53.3(15.3) °/s]. However, none of 12 static balance parameters derived from trunk acceleration significantly changed. Principal component analysis showed that before training, eyes closed and eyes open balance correlated with orthogonal components (one and two vs. three and four). After training, eyes open and eyes closed balance were more similar to each other being both correlated with component one. Responsiveness to rehabilitation is larger for gait than static balance measured by trunk acceleration. However, exercise can also have a beneficial effect on sensory ataxia by making eyes closed balance more similar to eyes open balance.

How do patients improve their timed up and go test? Responsiveness to rehabilitation of the TUG test in elderly neurological patients.

BACKGROUND: The timed up and go (TUG) test is widely used for assessing treatments effectiveness on elderly mobility. Although the TUG test consists of different tasks (e.g. walking and turning), the total TUG duration (TTD) is usually the only outcome measure, with TTD shortening indicating the patient's improvement. RESEARCH QUESTION: Does TTD shortening reflect the improvement of each TUG tasks or does it reflect the improvement of only some of them? METHODS: This retrospective study recruited 120 elderly patients (mean, SD: 76.9, 6.6 years) admitted to inpatient rehabilitation because of an acute or chronic neurological disease (acute patients, AP; chronic patients, CP). TTD and TUG tasks duration was measured on admission and discharge (five trials/session) by means of the instrumental TUG test (ITUG). Likelihood ratios (LRs) were used for inferring TUG tasks improvement from TTD improvement. TTD and TUG tasks have improved if at least four measurements on discharge were shorter than the shortest measurement on admission. RESULTS: TTD improvement per se is not enough to claim that all the TUG tasks have improved (LR+AP = 1.32; LR+CP = 1.85). Conversely, if TTD has not improved, not even a single TUG task has improved (LR-AP = 0.13; LR-CP = 0.19). If TTD has improved, there is at least one TUG task that actually improved (LR+AP = 3.17; LR+CP = 9.54). The improvement of all TUG tasks can be only inferred in the (unusual) event of a large TTD shortening (AP: >39%, LR+AP = 6.26; CP: >30%, LR+CP = 9.0). SIGNIFICANCE: In most cases, TTD improvement is not associated with the improvement of all TUG tasks. Moreover, when TTD has improved there is at least a TUG task that has improved, but that remains unknown. To actually understand how treatments ameliorate patients' mobility, ITUG with TUG task duration measurement should be preferred to TTD.

Criterion validity of the instrumented Timed Up and Go test: A partial least square regression study.

The Timed Up and Go (TUG) test is a common mobility measure in rehabilitation. With the instrumental TUG test (ITUG; i.e. the TUG measured by inertial measurement units, IMUs), several movement measures are newly available. However, the clinical meaning of these new measures is not totally clear. Aim of the current work is to evaluate the validity of different ITUG parameters as a measure of balance. Neurological patients (n = 122; 52 females; 89 older than 65 years) completed the TUG test with IMUs secured to their back. IMUs signals were used to split the TUG test in five phases (sit-to-stand, walk1, turn1, walk2 and turn-and-sit) and twelve movement parameters were obtained. Experienced clinicians administered the Mini-BESTest (MB) scale, a sound balance measure. The partial least square regression (PLSR) was used to explore the association between the ITUG variables and the MB measure. A PLSR model with twelve ITUG variables had satisfactory fit parameters (RMSEP: 11%; R2: 0.41, 95% CI: 0.28-0.54; regression line: 1, 95% CI: 0.78-1.22). Three ITUG variables (i.e. turn1 vertical angular velocity, turn1 duration and turn2 vertical angular velocity) were found to be the most important predictors of the MB measure. A PLSR model with the turning variables only had fit parameters comparable to that of the twelve variables model. Turning parameters from the TUG test are good predictors of the MB scale. The mean angular velocity during turning and the duration of the turning phase are thus proposed as a valid, ratio-level measures of balance in neurological patients.

Test-retest reliability of robotic assessment measures for the evaluation of upper limb recovery.

Rehabilitation robots have built-in technology and sensors that allow accurate measurement of movement kinematics and kinetics, which can be used to derive measures related to upper limb performance and highlight changes in motor behavior due to rehabilitation. This study aimed to assess the test-retest reliability of some robot-measured parameters by analyzing their intra-session and inter-session (day-by-day) variability. The study was carried out in two groups: 31 patients after stroke and 15 healthy subjects. Both groups practiced two different motor tasks consisting of point-to-point reaching movements in the shape of two geometrical figures that were selected for the assessment of global and directional (eight directions of the workspace) test-retest reliability. The reliability of six parameters measuring movement velocity, accuracy, efficiency and smoothness was assessed intra-session and inter-session by the ICC, SEM, and CV. Healthy subjects exhibited very high ICC values (> 0.85) and low SEM for all parameters. Patients had high ICC values and low SEM but their global reliability was generally lower compared to healthy subjects. In addition, their inter-session reliability showed very high ICC values (> 0.91) and low SEM for all parameters. Direction analysis showed that in some parameters the reliability was generally high but not homogeneous in all directions. In addition, some directions showed systematic error. This study demonstrates that robot-measured parameters are reliable and can be considered ideal candidates for use in combination with impairment and functional clinical scales to evaluate motor improvement during robot-assisted neurorehabilitation.

Robotic assessment of upper limb motor function after stroke.

Traditional assessment of a stroke subject's motor ability, carried out by a therapist who observes and rates the subject's motor behavior using ordinal measurements scales, is subjective, time consuming and lacks sensitivity. Rehabilitation robots, which have been the subject of intense inquiry over the last decade, are equipped with sensors that are used to develop objective measures of motor behaviors in a semiautomated way during therapy. This article reviews the current contributions of robot-assisted motor assessment of the upper limb. It summarizes the various measures related to movement performance, the models of motor recovery in stroke subjects and the relationship of robotic measures to standard clinical measures. It analyses the possibilities offered by current robotic assessment techniques and the aspects to address to make robotic assessment a mainstream motor assessment method.

Taking a lesson from patients' recovery strategies to optimize training during robot-aided rehabilitation.

In robot-assisted neurorehabilitation, matching the task difficulty level to the patient's needs and abilities, both initially and as the relearning process progresses, can enhance the effectiveness of training and improve patients' motivation and outcome. This study presents a Progressive Task Regulation algorithm implemented in a robot for upper limb rehabilitation. It evaluates the patient's performance during training through the computation of robot-measured parameters, and automatically changes the features of the reaching movements, adapting the difficulty level of the motor task to the patient's abilities. In particular, it can select different types of assistance (time-triggered, activity-triggered, and negative assistance) and implement varied therapy practice to promote generalization processes. The algorithm was tuned by assessing the performance data obtained in 22 chronic stroke patients who underwent robotic rehabilitation, in which the difficulty level of the task was manually adjusted by the therapist. Thus, we could verify the patient's recovery strategies and implement task transition rules to match both the patient's and therapist's behavior. In addition, the algorithm was tested in a sample of five chronic stroke patients. The findings show good agreement with the therapist decisions so indicating that it could be useful for the implementation of training protocols allowing individualized and gradual treatment of upper limb disabilities in patients after stroke. The application of this algorithm during robot-assisted therapy should allow an easier management of the different motor tasks administered during training, thereby facilitating the therapist's activity in the treatment of different pathologic conditions of the neuromuscular system.

Tracking motor improvement at the subtask level during robot-aided neurorehabilitation of stroke patients.

BACKGROUND: Robot-aided neurorehabilitation can provide intensive, repetitious training to improve upper-limb function after stroke. To be more effective, motor therapy ought to be progressive and continuously challenge the patient's ability. Current robotic systems have limited customization capability and require a physiotherapist to assess progress and adapt therapy accordingly. OBJECTIVE: The authors aimed to track motor improvement during robot-assistive training and test a tool to more automatically adjust training. METHODS: A total of 18 participants with chronic stroke were trained using a multicomponent reaching task assisted by a shoulder-elbow robotic assist. The time course of motor gains was assessed for each subtask of the practiced exercise. A statistical algorithm was then tested on simulated data to validate its ability to track improvement and subsequently applied to the recorded data to determine its performance compared with a therapist. RESULTS: Patients' recovery of motor function exhibited a time course dependent on the particular component of the executed task, suggesting that differential training on a subtask level is needed to continuously challenge the neuromuscular system and boost recovery. The proposed algorithm was tested on simulated data and was proven to track overall patient's progress during rehabilitation. CONCLUSIONS: Tuning of the training program at the subtask level may accelerate the process of motor relearning. The algorithm proposed to adjust task difficulty opens new possibilities to automatically customize robotic-assistive training.

Measuring changes of movement dynamics during robot-aided neurorehabilitation of stroke patients.

The aim of this study was to describe in detail a new method, called normalized force control parameter (nFCP), to measure changes in movement dynamics obtained during robot-aided neurorehabilitation, and to evaluate its ability to estimate the clinical scales. The study was conducted in a group of 18 subjects after chronic stroke who underwent robot therapy of the upper limb. We used two different measures of movement dynamics to assess patients' performance during each session of training: the nFCP and force directional error (FDE), both measuring the directional error of the patient-exerted force applied to the end-effector of the robot device. Both metrics exhibited significant changes over the three-week course of treatment. The comparison between nFCP and FDE slopes showed a significant and high correlation ( r = 0.79; p < 0.001), indicating that the two parameters are closely correlated. The FDE informed on the direction of the force error, while the nFCP showed a better performance in predicting the clinical scale values. Assessment of the time course of recovery showed that nFCP, FDE and the movement smoothness improved quickly at first and then plateaued, while steady gains in mean velocity of movement took place over a longer time course. These data may be helpful to the therapist in developing more effective robot-based therapy protocols.