Towards a validated glossary of usability attributes for the evaluation of wearable robotic devices.

BACKGROUND: Despite technical advances in the field of wearable robotic devices (WRD), there is still limited user acceptance of these technologies. While usability often comes as a key factor influencing acceptance, there is a scattered landscape of definitions and scopes for the term. To advance usability evaluation, and to integrate usability features as design requirements during technology development, there is a need for benchmarks and shared terminology. These should be easily accessible and implementable by developers. METHODS: An initial set of usability attributes (UA) was extracted from a literature survey on usability evaluation in WRD. The initial set of attributes was enriched and locally validated with seven developers of WRD through an online survey and a focus group. The locally validated glossary was then externally validated through a globally distributed online survey. RESULTS: The result is the Robotics Usability Glossary (RUG), a comprehensive glossary of 41 UA validated by 70 WRD developers from 17 countries, ensuring its generalizability. 31 of the UA had high agreement scores among respondents and 27 were considered highly relevant in the field, but only 11 of them had been included as design criteria by the respondents. CONCLUSIONS: Multiple UA ought to be considered for a comprehensive usability assessment. Usability remains inadequately incorporated into device development, indicating a need for increased awareness and end-user perspective. The RUG can be readily accessed through an online platform, the Interactive Usability Toolbox (IUT), developed to provide context-specific outcome measures and usability evaluation methods. Overall, this effort is an important step towards improving and promoting usability evaluation practices within WRD. It has the potential to pave the way for establishing usability evaluation benchmarks that further endorse the acceptance of WRD.

Unsupervised robot-assisted rehabilitation after stroke: feasibility, effect on therapy dose, and user experience.

BACKGROUND: Unsupervised robot-assisted rehabilitation is a promising approach to increase the dose of therapy after stroke, which may help promote sensorimotor recovery without requiring significant additional resources and manpower. However, the unsupervised use of robotic technologies is not yet a standard, as rehabilitation robots often show low usability or are considered unsafe to be used by patients independently. In this paper we explore the feasibility of unsupervised therapy with an upper limb rehabilitation robot in a clinical setting, evaluate the effect on the overall therapy dose, and assess user experience during unsupervised use of the robot and its usability. METHODS: Subacute stroke patients underwent a four-week protocol composed of daily 45 min-sessions of robot-assisted therapy. The first week consisted of supervised therapy, where a therapist explained how to interact with the device. The second week was minimally supervised, i.e., the therapist was present but intervened only if needed. After this phase, if participants learnt how to use the device, they proceeded to two weeks of fully unsupervised training. Feasibility, dose of robot-assisted therapy achieved during unsupervised use, user experience, and usability of the device were evaluated. Questionnaires to evaluate usability and user experience were performed after the minimally supervised week and at the end of the study, to evaluate the impact of therapists' absence. RESULTS: Unsupervised robot-assisted therapy was found to be feasible, as 12 out of the 13 recruited participants could progress to unsupervised training. During the two weeks of unsupervised therapy participants on average performed an additional 360 min of robot-assisted rehabilitation. Participants were satisfied with the device usability (mean System Usability Scale scores > 79), and no adverse events or device deficiencies occurred. CONCLUSIONS: We demonstrated that unsupervised robot-assisted therapy in a clinical setting with an actuated device for the upper limb was feasible and can lead to a meaningful increase in therapy dose. These results support the application of unsupervised robot-assisted therapy as a complement to usual care in clinical settings and pave the way to its application in home settings. TRIAL REGISTRATION: Registered on 13.05.2020 on clinicaltrials.gov (NCT04388891).

Hypothalamic Control of Forelimb Motor Adaptation.

The ability to perform skilled arm movements is central to everyday life, as limb impairments in common neurologic disorders such as stroke demonstrate. Skilled arm movements require adaptation of motor commands based on discrepancies between desired and actual movements, called sensory errors. Studies in humans show that this involves predictive and reactive movement adaptations to the errors, and also requires a general motivation to move. How these distinct aspects map onto defined neural signals remains unclear, because of a shortage of equivalent studies in experimental animal models that permit neural-level insights. Therefore, we adapted robotic technology used in human studies to mice, enabling insights into the neural underpinnings of motivational, reactive, and predictive aspects of motor adaptation. Here, we show that forelimb motor adaptation is regulated by neurons previously implicated in motivation and arousal, but not in forelimb motor control: the hypothalamic orexin/hypocretin neurons (HONs). By studying goal-oriented mouse-robot interactions in male mice, we found distinct HON signals occur during forelimb movements and motor adaptation. Temporally-delimited optosilencing of these movement-associated HON signals impaired sensory error-based motor adaptation. Unexpectedly, optosilencing affected neither task reward or execution rates, nor motor performance in tasks that did not require adaptation, indicating that the temporally-defined HON signals studied here were distinct from signals governing general task engagement or sensorimotor control. Collectively, these results reveal a hypothalamic neural substrate regulating forelimb motor adaptation.SIGNIFICANCE STATEMENT The ability to perform skilled, adaptable movements is a fundamental part of daily life, and is impaired in common neurologic diseases such as stroke. Maintaining motor adaptation is thus of great interest, but the necessary brain components remain incompletely identified. We found that impaired motor adaptation results from disruption of cells not previously implicated in this pathology: hypothalamic orexin/hypocretin neurons (HONs). We show that temporally confined HON signals are associated with skilled movements. Without these newly-identified signals, a resistance to movement that is normally rapidly overcome leads to prolonged movement impairment. These results identify natural brain signals that enable rapid and effective motor adaptation.

Effects of wrist posture and stabilization on precision grip force production and muscle activation patterns.

Most of the power for generating forces in the fingers arises from muscles located in the forearm. This configuration maximizes finger joint range of motion while minimizing finger mass and inertia. The resulting multiarticular arrangement of the tendons, however, complicates independent control of the wrist and the digits. Actuating the wrist impacts sensorimotor control of the fingers and vice versa. The goal of this study was to systematically investigate interactions between isometric wrist and digit control. Specifically, we examined how the need to maintain a specified wrist posture influences precision grip. Fifteen healthy adults produced maximum precision grip force at 11 different wrist flexion/extension angles, with the arm supported, under two conditions: 1) the participant maintained the desired wrist angle while performing the precision grip and 2) a robot maintained the specified wrist angle. Wrist flexion/extension posture significantly impacted maximum precision grip force (P < 0.001), with the greatest grip force achieved when the wrist was extended 30° from neutral. External wrist stabilization by the robot led to a 20% increase in precision grip force across wrist postures. Increased force was accompanied by increased muscle activation but with an activation pattern similar to the one used when the participant had to stabilize their wrist. Thus, simultaneous wrist and finger requirements impacted performance of an isometric finger task. External wrist stabilization can promote increased precision grip force resulting from increased muscle activation. These findings have potential clinical significance for individuals with neurologically driven finger weakness, such as stroke survivors.NEW & NOTEWORTHY We explored the interdependence between wrist and fingers by assessing the influence of wrist posture and external stabilization on precision grip force generation. We found that maximum precision grip force occurred at an extended wrist posture and was 20% greater when the wrist was Externally Stabilized. The latter resulted from amplification of muscle activation patterns from the Self-Stabilized condition rather than adoption of new patterns exploiting external wrist stabilization.

Feasibility of force myography for the direct control of an assistive robotic hand orthosis in non-impaired individuals.

BACKGROUND: Assistive robotic hand orthoses can support people with sensorimotor hand impairment in many activities of daily living and therefore help to regain independence. However, in order for the users to fully benefit from the functionalities of such devices, a safe and reliable way to detect their movement intention for device control is crucial. Gesture recognition based on force myography measuring volumetric changes in the muscles during contraction has been previously shown to be a viable and easy to implement strategy to control hand prostheses. Whether this approach could be efficiently applied to intuitively control an assistive robotic hand orthosis remains to be investigated. METHODS: In this work, we assessed the feasibility of using force myography measured from the forearm to control a robotic hand orthosis worn on the hand ipsilateral to the measurement site. In ten neurologically-intact participants wearing a robotic hand orthosis, we collected data for four gestures trained in nine arm configurations, i.e., seven static positions and two dynamic movements, corresponding to typical activities of daily living conditions. In an offline analysis, we determined classification accuracies for two binary classifiers (one for opening and one for closing) and further assessed the impact of individual training arm configurations on the overall performance. RESULTS: We achieved an overall classification accuracy of 92.9% (averaged over two binary classifiers, individual accuracies 95.5% and 90.3%, respectively) but found a large variation in performance between participants, ranging from 75.4 up to 100%. Averaged inference times per sample were measured below 0.15 ms. Further, we found that the number of training arm configurations could be reduced from nine to six without notably decreasing classification performance. CONCLUSION: The results of this work support the general feasibility of using force myography as an intuitive intention detection strategy for a robotic hand orthosis. Further, the findings also generated valuable insights into challenges and potential ways to overcome them in view of applying such technologies for assisting people with sensorimotor hand impairment during activities of daily living.

Mixed methods usability evaluation of an assistive wearable robotic hand orthosis for people with spinal cord injury.

BACKGROUND: Robotic hand orthoses (RHO) aim to provide grasp assistance for people with sensorimotor hand impairment during daily tasks. Many of such devices have been shown to bring a functional benefit to the user. However, assessing functional benefit is not sufficient to evaluate the usability of such technologies for daily life application. A comprehensive and structured evaluation of device usability not only focusing on effectiveness but also efficiency and satisfaction is required, yet often falls short in existing literature. Mixed methods evaluations, i.e., assessing a combination of quantitative and qualitative measures, allow to obtain a more holistic picture of all relevant aspects of device usability. Considering these aspects already in early development stages allows to identify design issues and generate generalizable benchmarks for future developments. METHODS: We evaluated the short-term usability of the RELab tenoexo, a RHO for hand function assistance, in 15 users with tetraplegia after a spinal cord injury through a comprehensive mixed methods approach. We collected quantitative data using the Action Research Arm Test (ARAT), the System Usability Scale (SUS), and timed tasks such as the donning process. In addition, qualitative data were collected through semi-structured interviews and user observations, and analyzed with a thematic analysis to enhance the usability evaluation. All insights were attributed and discussed in relation to specifically defined usability attributes such as comfort, ease of use, functional benefit, and safety. RESULTS: The RELab tenoexo provided an immediate functional benefit to the users, resulting in a mean improvement of the ARAT score by 5.8 points and peaking at 15 points improvement for one user (clinically important difference: 5.7 points). The mean SUS rating of 60.6 represents an adequate usability, however, indicating that especially the RHO donning (average task time = 295 s) was perceived as too long and cumbersome. The participants were generally very satisfied with the ergonomics (size, dimensions, fit) of the RHO. Enhancing the ease of use, specifically in donning, increasing the provided grasping force, as well as the availability of tailoring options and customization were identified as main improvement areas to promote RHO usability. CONCLUSION: The short-term usability of the RELab tenoexo was thoroughly evaluated with a mixed methods approach, which generated valuable data to improve the RHO in future iterations. In addition, learnings that might be transferable to the evaluation and design of other RHO were generated, which have the potential to increase the daily life applicability and acceptance of similar technologies.

A survey on the influence of CYBATHLON on the development and acceptance of advanced assistive technologies.

BACKGROUND: Advanced assistive technologies (AAT) aim to exploit the vast potential of technological developments made in the past decades to improve the quality of life of people with disabilities. Combining complex robotic technologies with the unique needs of people with disabilities requires a strong focus on user-centered design to ensure that the AAT appropriately addresses the daily life struggles of target users. The CYBATHLON aims to promote this mindset by empowering the AAT target users ("pilots") to compete on race tracks that represent approximations of daily life obstacles. The objective of this work was to investigate the AAT technology development, usability, and user involvement (i.e., application of user-centered design) in the context of the CYBATHLON. METHODS: With an online survey targeting the pilots and technical leads of teams preparing for the CYBATHLON 2020 Global Edition, we investigated to what extent the pilots were involved in device development and how this influences the perceived usability of the showcased AAT. Furthermore, the effects of user-centered design variables on the individual race performances were analyzed. RESULTS: A total of 81 responses from 35 pilots and 46 technical leads were collected in the two weeks prior to the event. Of all teams partaking in the included disciplines of the CYBATHLON 2020 Global Edition, 81.8% (36 of 44) were included in the study. User-centered design appeared to be a prevalent practice among the teams, as 85.7% of all pilots reported a certain level of involvement. However, only 25.5% of the pilots reported daily life usage, despite QUEST usability scores of both respondent groups showing moderate to high satisfaction with the respected AAT across all investigated disciplines. An explorative linear mixed model indicated that daily life usage (p < 0.05) and prolonged user involvement (e.g., more than 2 years, p < 0.001) have a significant positive effect on the race performance at the competition. CONCLUSIONS: We conclude that the CYBATHLON positively fulfills its conceptual goals of promoting active participation and inclusion of people with disabilities in the design and evaluation of AAT, thereby stimulating the development of promising novel technological solutions. Also, our data could underline the value of the competition as a benchmark, highlighting remaining usability limitations or technology adoption hurdles.

Clinical utility of a pediatric hand exoskeleton: identifying users, practicability, and acceptance, and recommendations for design improvement.

BACKGROUND: Children and adolescents with upper limb impairments can experience limited bimanual performance reducing daily-life independence. We have developed a fully wearable pediatric hand exoskeleton (PEXO) to train or compensate for impaired hand function. In this study, we investigated its appropriateness, practicability, and acceptability. METHODS: Children and adolescents aged 6-18 years with functional limitations in at least one hand due to a neurological cause were selected for this cross-sectional evaluation. We characterized participants by various clinical tests and quantified bimanual performance with the Assisting Hand Assessment (AHA). We identified children whose AHA scaled score increased by ≥ 7 points when using the hand exoskeleton and determined clinical predictors to investigate appropriateness. The time needed to don each component and the number of technical issues were recorded to evaluate practicability. For acceptability, the experiences of the patients and the therapist with PEXO were evaluated. We further noted any adverse events. RESULTS: Eleven children (median age 11.4 years) agreed to participate, but data was available for nine participants. The median AHA scaled score was higher with PEXO (68; IQR: 59.5-83) than without (55; IQR: 37.5-80.5; p = 0.035). The Box and Block test, the Selective Control of the Upper Extremity Scale, and finger extensor muscle strength could differentiate well between those participants who improved in AHA scaled scores by ≥ 7 points and those who did not (sensitivity and specificity varied between 0.75 and 1.00). The median times needed to don the back module, the glove, and the hand module were 62, 150, and 160 s, respectively, but all participants needed assistance. The most critical failures were the robustness of the transmission system, the electronics, and the attachment system. Acceptance was generally high, particularly in participants who improved bimanual performance with PEXO. Five participants experienced some pressure points. No adverse events occurred. CONCLUSIONS: PEXO is a safe exoskeleton that can improve bimanual hand performance in young patients with minimal hand function. PEXO receives high acceptance. We formulated recommendations to improve technical issues and the donning before such exoskeletons can be used under daily-life conditions for therapy or as an assistive device. Trial registration Not appropriate.

An analysis of usability evaluation practices and contexts of use in wearable robotics.

BACKGROUND: User-centered design approaches have gained attention over the past decade, aiming to tackle the technology acceptance issues of wearable robotic devices to assist, support or augment human capabilities. While there is a consensus that usability is key to user-centered design, dedicated usability evaluation studies are scarce and clear evaluation guidelines are missing. However, the careful consideration and integration of user needs appears to be essential to successfully develop an effective, efficient, and satisfactory human-robot interaction. It is primarily the responsibility of the developer, to ensure that this users involvement takes place throughout the design process. METHODS: Through an online survey for developers of wearable robotics, we wanted to understand how the design and evaluation in actual daily practice compares to what is reported in literature. With a total of 31 questions, we analyzed the most common wearable robotic device applications and their technology maturity, and how these influence usability evaluation practices. RESULTS: A total of 158 responses from a heterogeneous population were collected and analyzed. The dataset representing contexts of use for augmentation (16.5%), assistance (38.0%), therapy (39.8%), as well as few other specific applications (5.7%), allowed for an insightful analysis of the influence of technology maturity on user involvement and usability evaluation. We identified functionality, ease of use, and performance as the most evaluated usability attributes and could specify which measures are used to assess them. Also, we could underline the frequent use of qualitative measures alongside the expected high prevalence of performance-metrics. In conclusion of the analysis, we derived evaluation recommendations to foster user-centered design and usability evaluation. CONCLUSION: This analysis might serve as state-of-the-art comparison and recommendation for usability studies in wearable robotics. We believe that by motivating for more balanced, comparable and user-oriented evaluation practices, we may support the wearable robotics field in tackling the technology acceptance limitations.

Reliable and valid robot-assisted assessments of hand proprioceptive, motor and sensorimotor impairments after stroke.

BACKGROUND: Neurological injuries such as stroke often differentially impair hand motor and somatosensory function, as well as the interplay between the two, which leads to limitations in performing activities of daily living. However, it is challenging to identify which specific aspects of sensorimotor function are impaired based on conventional clinical assessments that are often insensitive and subjective. In this work we propose and validate a set of robot-assisted assessments aiming at disentangling hand proprioceptive from motor impairments, and capturing their interrelation (sensorimotor impairments). METHODS: A battery of five complementary assessment tasks was implemented on a one degree-of-freedom end-effector robotic platform acting on the index finger metacarpophalangeal joint. Specifically, proprioceptive impairments were assessed using a position matching paradigm. Fast target reaching, range of motion and maximum fingertip force tasks characterized motor function deficits. Finally, sensorimotor impairments were assessed using a dexterous trajectory following task. Clinical feasibility (duration), reliability (intra-class correlation coefficient ICC, smallest real difference SRD) and validity (Kruskal-Wallis test, Spearman correlations [Formula: see text] with Fugl-Meyer Upper Limb Motor Assessment, kinesthetic Up-Down Test, Box & Block Test) of robotic tasks were evaluated with 36 sub-acute stroke subjects and 31 age-matched neurologically intact controls. RESULTS: Eighty-three percent of stroke survivors with varied impairment severity (mild to severe) could complete all robotic tasks (duration: <15 min per tested hand). Further, the study demonstrated good to excellent reliability of the robotic tasks in the stroke population (ICC>0.7, SRD<30%), as well as discriminant validity, as indicated by significant differences (p-value<0.001) between stroke and control subjects. Concurrent validity was shown through moderate to strong correlations ([Formula: see text]=0.4-0.8) between robotic outcome measures and clinical scales. Finally, robotic tasks targeting different deficits (motor, sensory) were not strongly correlated with each other ([Formula: see text]0.32, p-value>0.1), thereby presenting complementary information about a patient's impairment profile. CONCLUSIONS: The proposed robot-assisted assessments provide a clinically feasible, reliable, and valid approach to distinctly characterize impairments in hand proprioceptive and motor function, along with the interaction between the two. This opens new avenues to help unravel the contributions of unique aspects of sensorimotor function in post-stroke recovery, as well as to contribute to future developments towards personalized, assessment-driven therapies.

Technology-aided assessment of functionally relevant sensorimotor impairments in arm and hand of post-stroke individuals.

BACKGROUND: Assessing arm and hand sensorimotor impairments that are functionally relevant is essential to optimize the impact of neurorehabilitation interventions. Technology-aided assessments should provide a sensitive and objective characterization of upper limb impairments, but often provide arm weight support and neglect the importance of the hand, thereby questioning their functional relevance. The Virtual Peg Insertion Test (VPIT) addresses these limitations by quantifying arm and hand movements as well as grip forces during a goal-directed manipulation task requiring active lifting of the upper limb against gravity. The aim of this work was to evaluate the ability of the VPIT metrics to characterize arm and hand sensorimotor impairments that are relevant for performing functional tasks. METHODS: Arm and hand sensorimotor impairments were systematically characterized in 30 chronic stroke patients using conventional clinical scales and the VPIT. For the latter, ten previously established kinematic and kinetic core metrics were extracted. The validity and robustness of these metrics was investigated by analyzing their clinimetric properties (test-retest reliability, measurement error, learning effects, concurrent validity). RESULTS: Twenty-three of the participants, the ones with mild to moderate sensorimotor impairments and without strong cognitive deficits, were able to successfully complete the VPIT protocol (duration 16.6 min). The VPIT metrics detected impairments in arm and hand in 90.0% of the participants, and were sensitive to increased muscle tone and pathological joint coupling. Most importantly, significant moderate to high correlations between conventional scales of activity limitations and the VPIT metrics were found, thereby indicating their functional relevance when grasping and transporting objects, and when performing dexterous finger manipulations. Lastly, the robustness of three out of the ten VPIT core metrics in post-stroke individuals was confirmed. CONCLUSIONS: This work provides evidence that technology-aided assessments requiring goal-directed manipulations without arm weight support can provide an objective, robust, and clinically feasible way to assess functionally relevant sensorimotor impairments in arm and hand in chronic post-stroke individuals with mild to moderate deficits. This allows for a better identification of impairments with high functional relevance and can contribute to optimizing the functional benefits of neurorehabilitation interventions.

Characterization and wearability evaluation of a fully portable wrist exoskeleton for unsupervised training after stroke.

BACKGROUND: Chronic hand and wrist impairment are frequently present following stroke and severely limit independence in everyday life. The wrist orientates and stabilizes the hand before and during grasping, and is therefore of critical importance in activities of daily living (ADL). To improve rehabilitation outcomes, classical therapy could be supplemented by novel therapies that can be applied in unsupervised settings. This would enable more distributed practice and could potentially increase overall training dose. Robotic technology offers new possibilities to address this challenge, but it is critical that devices for independent training are easy and appealing to use. Here, we present the development, characterization and wearability evaluation of a fully portable exoskeleton for active wrist extension/flexion support in stroke rehabilitation. METHODS: First we defined the requirements, and based on these, constructed the exoskeleton. We then characterized the device with standardized haptic and human-robot interaction metrics. The exoskeleton is composed of two modules placed on the forearm/hand and the upper arm. These modules weigh 238 g and 224 g, respectively. The forearm module actively supports wrist extension and flexion with a torque up to 3.7 Nm and an angular velocity up to 530 deg/s over a range of 154∘. The upper arm module includes the control electronics and battery, which can power the device for about 125 min in normal use. Special emphasis was put on independent donning and doffing of the device, which was tested via a wearability evaluation in 15 healthy participants and 2 stroke survivors using both qualitative and quantitative methods. RESULTS: All participants were able to independently don and doff the device after only 4 practice trials. For healthy participants the donning and doffing process took 61 ±15 s and 24 ±6 s, respectively. The two stroke survivors donned and doffed the exoskeleton in 54 s/22 s and 113 s/32 s, respectively. Usability questionnaires revealed that despite minor difficulties, all participants were positive regarding the device. CONCLUSIONS: This study describes an actuated wrist exoskeleton which weighs less than 500 g, and which is easy and fast to don and doff with one hand. Our design has put special emphasis on the donning aspect of robotic devices which constitutes the first barrier a user will face in unsupervised settings. The proposed device is a first and intermediate step towards wearable rehabilitation technologies that can be used independently by the patient and in unsupervised settings.

Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke.

BACKGROUND: Hand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke. METHODS: A parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance. RESULTS: Thirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group. CONCLUSIONS: Neurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke. TRIAL REGISTRATION: EUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445.

Systematic Review on Kinematic Assessments of Upper Limb Movements After Stroke.

Background and Purpose- Assessing upper limb movements poststroke is crucial to monitor and understand sensorimotor recovery. Kinematic assessments are expected to enable a sensitive quantification of movement quality and distinguish between restitution and compensation. The nature and practice of these assessments are highly variable and used without knowledge of their clinimetric properties. This presents a challenge when interpreting and comparing results. The purpose of this review was to summarize the state of the art regarding kinematic upper limb assessments poststroke with respect to the assessment task, measurement system, and performance metrics with their clinimetric properties. Subsequently, we aimed to provide evidence-based recommendations for future applications of upper limb kinematics in stroke recovery research. Methods- A systematic search was conducted in PubMed, Embase, CINAHL, and IEEE Xplore. Studies investigating clinimetric properties of applied metrics were assessed for risk of bias using the Consensus-Based Standards for the Selection of Health Measurement Instruments checklist. The quality of evidence for metrics was determined according to the Grading of Recommendations Assessment, Development, and Evaluation approach. Results- A total of 225 studies (N=6197) using 151 different kinematic metrics were identified and allocated to 5 task and 3 measurement system groups. Thirty studies investigated clinimetrics of 62 metrics: reliability (n=8), measurement error (n=5), convergent validity (n=22), and responsiveness (n=2). The metrics task/movement time, number of movement onsets, number of movement ends, path length ratio, peak velocity, number of velocity peaks, trunk displacement, and shoulder flexion/extension received a sufficient evaluation for one clinimetric property. Conclusions- Studies on kinematic assessments of upper limb sensorimotor function are poorly standardized and rarely investigate clinimetrics in an unbiased manner. Based on the available evidence, recommendations on the assessment task, measurement system, and performance metrics were made with the goal to increase standardization. Further high-quality studies evaluating clinimetric properties are needed to validate kinematic assessments, with the long-term goal to elucidate upper limb sensorimotor recovery poststroke. Clinical Trial Registration- URL: https://www.crd.york.ac.uk/prospero/ . Unique identifier: CRD42017064279.

Magnetometer-Based Drift Correction During Rest inIMU Arm Motion Tracking.

Real-time motion capture of the human arm in the home environment has many usecases, such as video game and therapy applications. The required tracking can be based onoff-the-shelf Inertial Measurement Units (IMUs) with integrated three-axis accelerometers, gyroscopes,and magnetometers. However, this usually requires a homogeneous magnetic field to correctfor orientation drift, which is often not available inside buildings. In this paper, RPMC (RestPose Magnetometer-based drift Correction), a novel method that is robust to long term drift inenvironments with inhomogeneous magnetic fields, is presented. The sensor orientation is estimatedby integrating the angular velocity measured by the gyroscope and correcting drift around the pitchand roll axes with the acceleration information. This commonly leads to short term drift aroundthe gravitational axis. Here, during the calibration phase, the local magnetic field direction for eachsensor, and its orientation relative to the inertial frame, are recorded in a rest pose. It is assumed thatarm movements in free space are exhausting and require regular rest. A set of rules is used to detectwhen the user has returned to the rest pose, to then correct for the drift that has occurred with themagnetometer. Optical validations demonstrated accurate (root mean square error RMS = 6.1), lowlatency (61 ms) tracking of the user's wrist orientation, in real time, for a full hour of arm movements.The reduction in error relative to three alternative methods implemented for comparison was between82.5% and 90.7% for the same movement and environment. Therefore, the proposed arm trackingmethod allows for the correction of orientation drift in an inhomogeneous magnetic field by exploitingthe user's need for frequent rest.

Development of VariLeg, an exoskeleton with variable stiffness actuation: first results and user evaluation from the CYBATHLON 2016.

BACKGROUND: Powered exoskeletons are a promising approach to restore the ability to walk after spinal cord injury (SCI). However, current exoskeletons remain limited in their walking speed and ability to support tasks of daily living, such as stair climbing or overcoming ramps. Moreover, training progress for such advanced mobility tasks is rarely reported in literature. The work presented here aims to demonstrate the basic functionality of the VariLeg exoskeleton and its ability to enable people with motor complete SCI to perform mobility tasks of daily life. METHODS: VariLeg is a novel powered lower limb exoskeleton that enables adjustments to the compliance in the leg, with the objective of improving the robustness of walking on uneven terrain. This is achieved by an actuation system with variable mechanical stiffness in the knee joint, which was validated through test bench experiments. The feasibility and usability of the exoskeleton was tested with two paraplegic users with motor complete thoracic lesions at Th4 and Th12. The users trained three times a week, in 60 min sessions over four months with the aim of participating in the CYBATHLON 2016 competition, which served as a field test for the usability of the exoskeleton. The progress on basic walking skills and on advanced mobility tasks such as incline walking and stair climbing is reported. Within this first study, the exoskeleton was used with a constant knee stiffness. RESULTS: Test bench evaluation of the variable stiffness actuation system demonstrate that the stiffness could be rendered with an error lower than 30 Nm/rad. During training with the exoskeleton, both users acquired proficient skills in basic balancing, walking and slalom walking. In advanced mobility tasks, such as climbing ramps and stairs, only basic (needing support) to intermediate (able to perform task independently in 25% of the attempts) skill levels were achieved. After 4 months of training, one user competed at the CYBATHLON 2016 and was able to perform 3 (stand-sit-stand, slalom and tilted path) out of 6 obstacles of the track. No adverse events occurred during the training or the competition. CONCLUSION: Demonstration of the applicability to restore ambulation for people with motor complete SCI was achieved. The CYBATHLON highlighted the importance of training and gaining experience in piloting an exoskeleton, which were just as important as the technical realization of the robot.

Reliability, validity, and clinical feasibility of a rapid and objective assessment of post-stroke deficits in hand proprioception.

BACKGROUND: Proprioceptive function can be affected after neurological injuries such as stroke. Severe and persistent proprioceptive impairments may be associated with a poor functional recovery after stroke. To better understand their role in the recovery process, and to improve diagnostics, prognostics, and the design of therapeutic interventions, it is essential to quantify proprioceptive deficits accurately and sensitively. However, current clinical assessments lack sensitivity due to ordinal scales and suffer from poor reliability and ceiling effects. Robotic technology offers new possibilities to address some of these limitations. Nevertheless, it is important to investigate the psychometric and clinimetric properties of technology-assisted assessments. METHODS: We present an automated robot-assisted assessment of proprioception at the level of the metacarpophalangeal joint, and evaluate its reliability, validity, and clinical feasibility in a study with 23 participants with stroke and an age-matched group of 29 neurologically intact controls. The assessment uses a two-alternative forced choice paradigm and an adaptive sampling procedure to identify objectively the difference threshold of angular joint position. RESULTS: Results revealed a good reliability (ICC(2,1) = 0.73) for assessing proprioception of the impaired hand of participants with stroke. Assessments showed similar task execution characteristics (e.g., number of trials and duration per trial) between participants with stroke and controls and a short administration time of approximately 12 min. A difference in proprioceptive function could be found between participants with a right hemisphere stroke and control subjects (p<0.001). Furthermore, we observed larger proprioceptive deficits in participants with a right hemisphere stroke compared to a left hemisphere stroke (p=0.028), despite the exclusion of participants with neglect. No meaningful correlation could be established with clinical scales for different modalities of somatosensation. We hypothesize that this is due to their low resolution and ceiling effects. CONCLUSIONS: This study has demonstrated the assessment's applicability in the impaired population and promising integration into clinical routine. In conclusion, the proposed assessment has the potential to become a powerful tool to investigate proprioceptive deficits in longitudinal studies as well as to inform and adjust sensorimotor rehabilitation to the patient's deficits.

Concurrent validity and test-retest reliability of the Virtual Peg Insertion Test to quantify upper limb function in patients with chronic stroke.

BACKGROUND: Measuring arm and hand function of the affected side is vital in stroke rehabilitation. Therefore, the Virtual Peg Insertion Test (VPIT), an assessment combining virtual reality and haptic feedback during a goal-oriented task derived from the Nine Hole Peg Test (NHPT), was developed. This study aimed to evaluate (1) the concurrent validity of key outcome measures of the VPIT, namely the execution time and the number of dropped pegs, with the NHPT and Box and Block Test (BBT), and (2) the test-retest-reliability of these parameters together with the VPIT's additional kinetic and kinematic parameters in patients with chronic stroke. The three tests were administered on 31 chronic patients with stroke in one session (concurrent validity), and the VPIT was retested in a second session 3-7 days later (test-retest reliability). Spearman rank correlation coefficients (ρ) were calculated for assessing concurrent validity, and intraclass correlation coefficients (ICCs) were used to determine relative reliability. Bland-Altman plots were drawn and the smallest detectable difference (SDD) was calculated to examine absolute reliability. RESULTS: For the 31 included patients, 11 were able to perform the VPIT solely via use of their affected arm, whereas 20 patients also had to utilize support from their unaffected arm. For n = 31, the VPIT showed low correlations with the NHPT (ρ = 0.31 for time (Tex[s]); ρ = 0.21 for number of dropped pegs (Ndp)) and BBT (ρ = -0.23 for number of transported cubes (Ntc); ρ = -0.12 for number of dropped cubes (Ndc)). The test-retest reliability for the parameters Tex[s], mean grasping force (Fggo[N]), number of zero-crossings (Nzc[1/sgo/return) and mean collision force (Fcmean[N]) were good to high, with ICCs ranging from 0.83 to 0.94. Fair reliability could be found for Fgreturn (ICC = 0.75) and trajectory error (Etrajgo[cm]) (0.70). Poor reliability was measured for Etrajreturn[cm] (0.67) and Ndp (0.58). The SDDs were: Tex = 70.2 s, Ndp = 0.4 pegs; Fggo/return = 3.5/1.2 Newton; Nzc[1/s]go/return = 0.2/1.8 zero-crossings; Etrajgo/return = 0.5/0.8 cm; Fcmean = 0.7 Newton. CONCLUSIONS: The VPIT is a promising upper limb function assessment for patients with stroke requiring other components of upper limb motor performance than the NHPT and BBT. The high intra-subject variation indicated that it is a demanding test for this stroke sample, which necessitates a thorough introduction to this assessment. Once familiar, the VPIT provides more objective and comprehensive measurements of upper limb function than conventional, non-computerized hand assessments.

Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system.

BACKGROUND: The effect of rehabilitative training after stroke is dose-dependent. Out-patient rehabilitation training is often limited by transport logistics, financial resources and a lack of motivation/compliance. We studied the feasibility of an unsupervised arm therapy for self-directed rehabilitation therapy in patients' homes. METHODS: An open-label, single group study involving eleven patients with hemiparesis due to stroke (27 ± 31.5 months post-stroke) was conducted. The patients trained with an inertial measurement unit (IMU)-based virtual reality system (ArmeoSenso) in their homes for six weeks. The self-selected dose of training with ArmeoSenso was the principal outcome measure whereas the Fugl-Meyer Assessment of the upper extremity (FMA-UE), the Wolf Motor Function Test (WMFT) and IMU-derived kinematic metrics were used to assess arm function, training intensity and trunk movement. Repeated measures one-way ANOVAs were used to assess differences in training duration and clinical scores over time. RESULTS: All subjects were able to use the system independently in their homes and no safety issues were reported. Patients trained on 26.5 ± 11.5 days out of 42 days for a duration of 137 ± 120 min per week. The weekly training duration did not change over the course of six weeks (p = 0.146). The arm function of these patients improved significantly by 4.1 points (p = 0.003) in the FMA-UE. Changes in the WMFT were not significant (p = 0.552). ArmeoSenso based metrics showed an improvement in arm function, a high number of reaching movements (387 per session), and minimal compensatory movements of the trunk while training. CONCLUSIONS: Self-directed home therapy with an IMU-based home therapy system is safe and can provide a high dose of rehabilitative therapy. The assessments integrated into the system allow daily therapy monitoring, difficulty adaptation and detection of maladaptive motor patterns such as trunk movements during reaching. TRIAL REGISTRATION: Unique identifier: NCT02098135 .

Control strategies for active lower extremity prosthetics and orthotics: a review.

: Technological advancements have led to the development of numerous wearable robotic devices for the physical assistance and restoration of human locomotion. While many challenges remain with respect to the mechanical design of such devices, it is at least equally challenging and important to develop strategies to control them in concert with the intentions of the user.This work reviews the state-of-the-art techniques for controlling portable active lower limb prosthetic and orthotic (P/O) devices in the context of locomotive activities of daily living (ADL), and considers how these can be interfaced with the user's sensory-motor control system. This review underscores the practical challenges and opportunities associated with P/O control, which can be used to accelerate future developments in this field. Furthermore, this work provides a classification scheme for the comparison of the various control strategies.As a novel contribution, a general framework for the control of portable gait-assistance devices is proposed. This framework accounts for the physical and informatic interactions between the controller, the user, the environment, and the mechanical device itself. Such a treatment of P/Os--not as independent devices, but as actors within an ecosystem--is suggested to be necessary to structure the next generation of intelligent and multifunctional controllers.Each element of the proposed framework is discussed with respect to the role that it plays in the assistance of locomotion, along with how its states can be sensed as inputs to the controller. The reviewed controllers are shown to fit within different levels of a hierarchical scheme, which loosely resembles the structure and functionality of the nominal human central nervous system (CNS). Active and passive safety mechanisms are considered to be central aspects underlying all of P/O design and control, and are shown to be critical for regulatory approval of such devices for real-world use.The works discussed herein provide evidence that, while we are getting ever closer, significant challenges still exist for the development of controllers for portable powered P/O devices that can seamlessly integrate with the user's neuromusculoskeletal system and are practical for use in locomotive ADL.