Experimental Validation of an Upper Limb Benchmarking Framework in Healthy and Post-Stroke Individuals: A Pilot Study.

In the context of neurorehabilitation, there have been rapid and continuous improvements in sensors-based clinical tools to quantify limb performance. As a result of the increasing integration of technologies in the assessment procedure, the need to integrate evidence-based medicine with benchmarking has emerged in the scientific community. In this work, we present the experimental validation of our previously proposed benchmarking scheme for upper limb capabilities in terms of repeatability, reproducibility, and clinical meaningfulness. We performed a prospective multicenter study on neurologically intact young and elderly subjects and post-stroke patients while recording kinematics and electromyography. 60 subjects (30 young healthy, 15 elderly healthy, and 15 post-stroke) completed the benchmarking protocol. The framework was repeatable among different assessors and instrumentation. Age did not significantly impact the performance indicators of the scheme for healthy subjects. In post-stroke subjects, the movements presented decreased smoothness and speed, the movement amplitude was reduced, and the muscular activation showed lower power and lower intra-limb coordination. We revised the original framework reducing it to three motor skills, and we extracted 14 significant performance indicators with a good correlation with the ARAT clinical scale. The applicability of the scheme is wide, and it may be considered a valuable tool for upper limb functional evaluation in the clinical routine.

Instrumented Upper Limb Functional Assessment Using a Robotic Exoskeleton: Normative References Intervals.

Upper-limb rehabilitation exoskeletons offer a valuable solution to support and enhance the rehabilitation path of neural-injured patients. Such devices are usually equipped with a network of sensors that can be exploited to evaluate and monitor the performances of the users. In this work, we assess the normality ranges of different motor-performance indicators on a group of 15 healthy participants, computed with the benchmark toolbox of AGREE, an upper limb motorized exoskeleton. The toolbox implements a benchmarking scheme for the evaluation of the upper limb, used to test anterior reaching at rest position height and hand-to-mouth motor skills. We selected kinematic and electromyography performance indicators to assess the different motor abilities. We performed a pilot evaluation on three neurological patients, to verify if the AGREE benchmark toolbox was able to distinguish patients from healthy subjects on the basis of the selected performance indicators. Through a comparison between results obtained by the healthy and the small group of motor-impaired users, we successfully calculated the normality ranges for the selected performance indicators, and we pilot-showed how data gathered from AGREE can be used to evaluate the current status of the patients.

A unified scheme for the benchmarking of upper limb functions in neurological disorders.

BACKGROUND: In neurorehabilitation, we are witnessing a growing awareness of the importance of standardized quantitative assessment of limb functions. Detailed assessments of the sensorimotor deficits following neurological disorders are crucial. So far, this assessment has relied mainly on clinical scales, which showed several drawbacks. Different technologies could provide more objective and repeatable measurements. However, the current literature lacks practical guidelines for this purpose. Nowadays, the integration of available metrics, protocols, and algorithms into one harmonized benchmarking ecosystem for clinical and research practice is necessary. METHODS: This work presents a benchmarking framework for upper limb capacity. The scheme resulted from a multidisciplinary and iterative discussion among several partners with previous experience in benchmarking methodology, robotics, and clinical neurorehabilitation. We merged previous knowledge in benchmarking methodologies for human locomotion and direct clinical and engineering experience in upper limb rehabilitation. The scheme was designed to enable an instrumented evaluation of arm capacity and to assess the effectiveness of rehabilitative interventions with high reproducibility and resolution. It includes four elements: (1) a taxonomy for motor skills and abilities, (2) a list of performance indicators, (3) a list of required sensor modalities, and (4) a set of reproducible experimental protocols. RESULTS: We proposed six motor primitives as building blocks of most upper-limb daily-life activities and combined them into a set of functional motor skills. We identified the main aspects to be considered during clinical evaluation, and grouped them into ten motor abilities categories. For each ability, we proposed a set of performance indicators to quantify the proposed ability on a quantitative and high-resolution scale. Finally, we defined the procedures to be followed to perform the benchmarking assessment in a reproducible and reliable way, including the definition of the kinematic models and the target muscles. CONCLUSIONS: This work represents the first unified scheme for the benchmarking of upper limb capacity. To reach a consensus, this scheme should be validated with real experiments across clinical conditions and motor skills. This validation phase is expected to create a shared database of human performance, necessary to have realistic comparisons of treatments and drive the development of new personalized technologies.

AGREE: an upper-limb robotic platform for personalized rehabilitation, concept and clinical study design.

Rehabilitation exoskeletons can supplement therapist-based training allowing post-stroke patients to perform functional, high-dosage, repetitive exercises. The use of robotic devices allows providing intense rehabilitation sessions and permits clinicians to personalize the therapy according to the patient's need. In this work, we propose an upper-limb rehabilitation system developed within the AGREE project. The platform relies on a four degrees-of-freedom arm exoskeleton, capable of assisting state-of-the-art rehabilitation exercises under different training modalities while behaving transparently to user-generated and therapist-applied forces. The system is provided with a LEDs-matrix mat to guide patients during reaching tasks with visual feedback, an EMG reader to evaluate the patient's involvement during the therapy, and several software tools to help clinicians customize the treatment and monitor the patient's progress. A randomized controlled pilot study aimed at evaluating the usability and the effectiveness of the AGREE rehabilitation platform to improve arm impairment after stroke is currently ongoing.

Robotic Exoskeleton Gait Training in Stroke: An Electromyography-Based Evaluation.

The recovery of symmetric and efficient walking is one of the key goals of a rehabilitation program in patients with stroke. The use of overground exoskeletons alongside conventional gait training might help foster rhythmic muscle activation in the gait cycle toward a more efficient gait. About twenty-nine patients with subacute stroke have been recruited and underwent either conventional gait training or experimental training, including overground gait training using a wearable powered exoskeleton alongside conventional therapy. Before and after the rehabilitation treatment, we assessed: (i) gait functionality by means of clinical scales combined to obtain a Capacity Score, and (ii) gait neuromuscular lower limbs pattern using superficial EMG signals. Both groups improved their ability to walk in terms of functional gait, as detected by the Capacity Score. However, only the group treated with the robotic exoskeleton regained a controlled rhythmic neuromuscular pattern in the proximal lower limb muscles, as observed by the muscular activation analysis. Coherence analysis suggested that the control group (CG) improvement was mediated mainly by spinal cord control, while experimental group improvements were mediated by cortical-driven control. In subacute stroke patients, we hypothesize that exoskeleton multijoint powered fine control overground gait training, alongside conventional care, may lead to a more fine-tuned and efficient gait pattern.

User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study.

BACKGROUND: Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. METHODS: We conducted a cross-over multi-centric randomized controlled trial to assess the functional improvement at the upper limb level of two arms supports on 36 patients with muscular dystrophy. Participants tested a passive device (i.e., Wrex by Jaeco) and a semi-active solution for gravity compensation (i.e., Armon Ayura). We evaluated devices' effectiveness with an externally-assessed scale (i.e., Performance of the Upper Limb-PUL-module), a self-perceived scale (i.e., Abilhand questionnaire), and a usability scale (i.e., System Usability Scale). Friedman's test was used to assess significant functional gain for PUL module and Abilhand questionnaire. Moreover, PUL changes were compared by means of the Friedman's test. RESULTS: Most of the patients improved upper limb function with the use of arm supports (median PUL scores increase of 1-3 points). However, the effectiveness of each device was related to the level of residual ability of the end-user. Slightly impaired patients maintained the same independence without and with assistive devices, even if they reported reduced muscular fatigue for both devices. Moderately impaired patients enhanced their arm functionality with both devices, and they obtained higher improvements with the semi-active one (median PUL scores increase of 9 points). Finally, severely impaired subjects benefited only from the semi-active device (median PUL scores increase of 12 points). Inadequate strength was recognized as a barrier to passive devices. The usability, measured by the System Usability Scale, was evaluated by end-users "good" (70/100 points) for the passive, and "excellent" (80/100 points) for the semi-active device. CONCLUSIONS: This study demonstrated that assistive devices can improve the quality of life of people suffering from muscular dystrophy. The use of passive devices, despite being low cost and easy to use, shows limitations in the efficacy of the assistance to daily tasks, limiting the assistance to a predefined horizontal plane. The addition of one active degree of freedom improves efficacy and usability especially for medium to severe patients. Further investigations are needed to increase the evidence on the effect of arm supports on quality of life and diseases' progression in subjects with degenerative disorders. Trial registration clinicaltrials.gov, NCT03127241, Registered 25th April 2017. The clinical trial was also registered as a post-market study at the Italian Ministry of Health.

Development and Electromyographic Validation of a Compliant Human-Robot Interaction Controller for Cooperative and Personalized Neurorehabilitation.

BACKGROUND: Appropriate training modalities for post-stroke upper-limb rehabilitation are key features for effective recovery after the acute event. This study presents a cooperative control framework that promotes compliant motion and implements a variety of high-level rehabilitation modalities with a unified low-level explicit impedance control law. The core idea is that we can change the haptic behavior perceived by a human when interacting with the rehabilitation robot by tuning three impedance control parameters. METHODS: The presented control law is based on an impedance controller with direct torque measurement, provided with positive-feedback compensation terms for disturbances rejection and gravity compensation. We developed an elbow flexion-extension experimental setup as a platform to validate the performance of the proposed controller to promote the desired high-level behavior. The controller was first characterized through experimental trials regarding joint transparency, torque, and impedance tracking accuracy. Then, to validate if the controller could effectively render different physical human-robot interaction according to the selected rehabilitation modalities, we conducted tests on 14 healthy volunteers and measured their muscular voluntary effort through surface electromyography (sEMG). The experiments consisted of one degree-of-freedom elbow flexion/extension movements, executed under six high-level modalities, characterized by different levels of (i) corrective assistance, (ii) weight counterbalance assistance, and (iii) resistance. RESULTS: The unified controller demonstrated suitability to promote good transparency and render both compliant and stiff behavior at the joint. We demonstrated through electromyographic monitoring that a proper combination of stiffness, damping, and weight assistance could induce different user participation levels, render different physical human-robot interaction, and potentially promote different rehabilitation training modalities. CONCLUSION: We proved that the proposed control framework could render a wide variety of physical human-robot interaction, helping the user to accomplish the task while exploiting physiological muscular activation patterns. The reported results confirmed that the control scheme could induce different levels of the subject's participation, potentially applicable to the clinical practice to adapt the rehabilitation treatment to the subject's progress. Further investigation is needed to validate the presented approach to neurological patients.

Test-retest reliability of the Performance of Upper Limb (PUL) module for muscular dystrophy patients.

The Performance of the Upper Limb (PUL) module is an externally-assessed clinical scale, initially designed for the Duchenne muscular dystrophy population. It provides an upper extremity functional score suitable for both weaker ambulatory and non-ambulatory phases up to the severely impaired patients. It is capable of characterizing overall progression and severity of disease and of tracking the stereotypical proximal-to-distal progressive loss of upper limb function in muscular dystrophy. Since the PUL module has been validated only with Duchenne patients, its use also for Becker and Limb-Girdle muscular dystrophy patients has been here evaluated, to verify its reliability and extend its use. In particular, two different assessors performed this scale on 32 dystrophic subjects in two consecutive days. The results showed that the PUL module has high reliability, both absolute and relative, based on the calculation of Pearson's r (0.9942), Intraclass Correlation Coefficient (0.9943), Standard Error of Measurement (1.36), Minimum Detectable Change (3.77), and Coefficient of Variation (3%). The Minimum Detectable Change, in particular, can be used in clinical trials to perform a comprehensive longitudinal evaluation of the effects of interventions with the lapse of time. According to this analysis, an intervention is effective if the difference in the PUL score between subsequent evaluation points is equal or higher than 4 points; otherwise, the observed effect is not relevant. Inter-rater reliability with ten different assessors was evaluated, and it has been demonstrated that deviation from the mean is lower than calculated Minimum Detectable Change. The present work provides evidence that the PUL module is a reliable and valid instrument for measuring upper limb ability in people with different forms of muscular dystrophy. Therefore, the PUL module might be extended to other pathologies and reliably used in multicenter settings.

The Effectiveness of Wearable Upper Limb Assistive Devices in Degenerative Neuromuscular Diseases: A Systematic Review and Meta-Analysis.

Background: This systematic review summarizes the current evidence about the effectiveness of wearable assistive technologies for upper limbs support during activities of daily living for individuals with neuromuscular diseases. Methods: Fourteen studies have been included in the meta-analysis, involving 184 participants. All included studies compared patients ability to perform functional tasks with and without assistive devices. Results: An overall effect size of 1.06 (95% CI = 0.76-1.36, p < 0.00001) was obtained, demonstrating that upper limbs assistive devices significantly improve the performance in activities of daily living in people with neuromuscular diseases. A significant interaction between studies evaluating functional improvement with externally-assessed outcome measures or self-perceived outcome measures has been detected. In particular, the effect size of the sub-group considering self-perceived scales was 1.38 (95% CI = 1.08-1.68), while the effect size of the other group was 0.77 (95% CI = 0.41-1.11), meaning that patients' perceived functional gain is often higher than the functional gain detectable through clinical scales. Conclusion: Overall, the quality of the evidence ranged from low to moderate, due to low number of studies and participants, limitations in the selection of participants and in the blindness of outcome assessors, and risk of publication bias. Significance: A large magnitude effect and a clear dose-response gradient were found, therefore, a strong recommendation, in favor of the use of assistive devices could be suggested.