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Abstract 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).

Abstract 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.

Upper-limb spasticity, frequent after central nervous system lesions, is typically treated with botulinum neurotoxin type A (BoNT-A) injections to reduce muscle tone and increase range of motion. However, performing adjunct physical therapy post-BoNT-A can be challenging due to residual weakness or spasticity. This study evaluates the feasibility of hand therapy using a robotic hand orthosis (RELab tenoexo) with a mobile phone application as an adjunct to BoNT-A injections. Five chronic spastic patients participated in a two-session pilot study. Functional (Box and Block Test (BBT), Action Research Arm Test (ARAT)), and muscle tone (Modified Ashworth Scale (MAS)) assessments were conducted to assess functional abilities and impairment, along with usability evaluations. In the first session, subjects received BoNT-A injections, and then they performed a simulated unsupervised therapy session with the RELab tenoexo in a second session a month later. Results showed that BoNT-A reduced muscle tone (from 12.2 to 7.4 MAS points). The addition of RELab tenoexo therapy was safe, led to functional improvements in four subjects (two-cube increase in BBT as well as 2.8 points in grasp and 1.3 points in grip on ARAT). Usability results indicate that, with minor improvements, adjunct RELab tenoexo therapy could enhance therapy doses and, potentially, long-term outcomes.

BackgroundIncreasing the dose of therapy delivered to patients with stroke may improve functional outcomes and quality of life. Unsupervised technology-assisted rehabilitation is a promising way to increase the dose of therapy without dramatically increasing the burden on the health care system. Despite the many existing technologies for unsupervised rehabilitation, active rehabilitation robots have rarely been tested in a fully unsupervised way. Furthermore, the outcomes of unsupervised technology-assisted therapy (eg, feasibility, acceptance, and increase in therapy dose) vary widely. This might be due to the use of different technologies as well as to the broad range of methods applied to teach the patients how to independently train with a technology. ObjectiveThis paper describes the study design of a clinical study investigating the feasibility of unsupervised therapy with an active robot and of a systematic approach for the progressive transition from supervised to unsupervised use of a rehabilitation technology in a clinical setting. The effect of unsupervised therapy on achievable therapy dose, user experience in this therapy setting, and the usability of the rehabilitation technology are also evaluated. MethodsParticipants of the clinical study are inpatients of a rehabilitation clinic with subacute stroke undergoing a 4-week intervention where they train with a hand rehabilitation robot. The first week of the intervention is supervised by a therapist, who teaches participants how to interact and train with the device. The second week consists of minimally supervised therapy, where the therapist is present but intervenes only if needed as participants exercise with the device. If the participants properly learn how to train with the device, they proceed to the unsupervised phase and train without any supervision during the third and fourth weeks. Throughout the duration of the study, data on feasibility and therapy dose (ie, duration and repetitions) are collected. Usability and user experience are evaluated at the end of the second (ie, minimally supervised) and fourth (ie, unsupervised) weeks, allowing us to investigate the effect of therapist absence. ResultsAs of April 2023, 13 patients were recruited and completed the protocol, with no reported adverse events. ConclusionsThis study will inform on the feasibility of fully unsupervised rehabilitation with an active rehabilitation robot in a clinical setting and its effect on therapy dose. Furthermore, if successful, the proposed systematic approach for a progressive transition from supervised to unsupervised technology-assisted rehabilitation could serve as a benchmark to allow for easier comparisons between different technologies. This approach could also be extended to the application of such technologies in the home environment, as the supervised and minimally supervised sessions could be performed in the clinic, followed by unsupervised therapy at home after discharge. Trial RegistrationClinicalTrials.gov NCT04388891; https://clinicaltrials.gov/study/NCT04388891 International Registered Report Identifier (IRRID)DERR1-10.2196/48485

Introduction: Robot-assisted neurorehabilitation is becoming an established method to complement conventional therapy after stroke and provide intensive therapy regimes in unsupervised settings (e.g., home rehabilitation). Intensive therapies may temporarily contribute to increasing muscle tone and spasticity, especially in stroke patients presenting tone alterations. If sustained without supervision, such an increase in muscle tone could have negative effects (e.g., functional disability, pain). We propose an online perturbation-based method that monitors finger muscle tone during unsupervised robot-assisted hand therapy exercises.Methods: We used the ReHandyBot, a novel 2 degrees of freedom (DOF) haptic device to perform robot-assisted therapy exercises training hand grasping (i.e., flexion-extension of the fingers) and forearm pronosupination. The tone estimation method consisted of fast (150 ms) and slow (250 ms) 20 mm ramp-and-hold perturbations on the grasping DOF, which were applied during the exercises to stretch the finger flexors. The perturbation-induced peak force at the finger pads was used to compute tone. In this work, we evaluated the method performance in a stiffness identification experiment with springs (0.97 and 1.57 N/mm), which simulated the stiffness of a human hand, and in a pilot study with subjects with increased muscle tone after stroke and unimpaired, which performed one active sensorimotor exercise embedding the tone monitoring method.Results: The method accurately estimates forces with root mean square percentage errors of 3.8% and 11.3% for the soft and stiff spring, respectively. In the pilot study, six chronic ischemic stroke patients [141.8 (56.7) months after stroke, 64.3 (9.5) years old, expressed as mean (std)] and ten unimpaired subjects [59.9 (6.1) years old] were tested without adverse events. The average reaction force at the level of the fingertip during slow and fast perturbations in the exercise were respectively 10.7 (5.6) N and 13.7 (5.6) N for the patients and 5.8 (4.2) N and 6.8 (5.1) N for the unimpaired subjects.Discussion: The proposed method estimates reaction forces of physical springs accurately, and captures online increased reaction forces in persons with stroke compared to unimpaired subjects within unsupervised human-robot interactions. In the future, the identified range of muscle tone increase after stroke could be used to customize therapy for each subject and maintain safety during intensive robot-assisted rehabilitation.

Introduction: There is evidence that increasing therapy dose after stroke might promote recovery. Unfortunately, in clinical practice, therapy dose is limited by financial and organizational constraints. Simple robotic devices could be used without supervision in the clinic or at home to increase dose without requiring additional resources. For this purpose, we developed HandyBot, a portable three-degrees-of-freedom end-effector haptic device to perform sensorimotor task-oriented therapy of hand function (i.e., grasping, forearm pronosupination, wrist flexion-extension) in different environments.Methods: We present the mechatronic design of the device and its technical evaluation in terms of workspace, dynamics (i.e., max end-effector velocity, acceleration and force), sensing (i.e., position, velocity and force resolution) and haptic performance (i.e., transparency, maximum stable impedance range, rigid contact rendering accuracy). In addition, its feasibility and usability (in terms of System Usability Scale (SUS)) were assessed in a single-session experiment with four subjects with chronic stroke that tested the HandyBot therapy platform (i.e., haptic device with a graphical/physical user interface and a set of therapy exercises) while simulating unsupervised use (i.e., the subject used the device independently while a therapist was only observing the session).Results: HandyBot showed hardware and control performances comparable to other less portable therapy devices for hand function (e.g., 94% accuracy in stiffness rendering, low apparent mass of 0.2 kg in transparency mode), making it a suitable platform for the implementation of sensorimotor therapy exercises. HandyBot showed good platform usability in terms of SUS (i.e., above 75 out of 100 for device and graphical user interfaces, above 65 out of 100 for the exercises) when tested in simulated unsupervised settings. These tests underlined minor design improvements that should be considered to allow using such a device in uncontrolled settings.Discussion: HandyBot is a novel robot for hand rehabilitation after stroke that revealed high-quality hardware and haptic performance. HandyBot was usable for stroke patients at first exposure for (simulated) unsupervised robot-assisted sensorimotor therapy of hand function. This therapy approach combined with this novel portable robotic device has the potential to help increase therapy dose and decrease therapy-associated costs (e.g., therapist time to therapy time ratio) in different environments.

Abstract 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

BackgroundRobot-assisted therapy can increase therapy dose after stroke, which is often considered insufficient in clinical practice and after discharge, especially with respect to hand function. Thus far, there has been a focus on rather complex systems that require therapist supervision. To better exploit the potential of robot-assisted therapy, we propose a platform designed for minimal therapist supervision, and present the preliminary evaluation of its immediate usability, one of the main and frequently neglected challenges for real-world application. Such an approach could help increase therapy dose by allowing the training of multiple patients in parallel by a single therapist, as well as independent training in the clinic or at home.MethodsWe implemented design changes on a hand rehabilitation robot, considering aspects relevant to enabling minimally-supervised therapy, such as new physical/graphical user interfaces and two functional therapy exercises to train hand motor coordination, somatosensation and memory. Ten participants with chronic stroke assessed the usability of the platform and reported the perceived workload during a single therapy session with minimal supervision. The ability to independently use the platform was evaluated with a checklist.ResultsParticipants were able to independently perform the therapy session after a short familiarization period, requiring assistance in only 13.46 (7.69–19.23)% of the tasks. They assigned good-to-excellent scores on the System Usability Scale to the user-interface and the exercises [85.00 (75.63–86.88) and 73.75 (63.13–83.75) out of 100, respectively]. Nine participants stated that they would use the platform frequently. Perceived workloads lay within desired workload bands. Object grasping with simultaneous control of forearm pronosupination and stiffness discrimination were identified as the most difficult tasks.DiscussionOur findings demonstrate that a robot-assisted therapy device can be rendered safely and intuitively usable upon first exposure with minimal supervision through compliance with usability and perceived workload requirements. The preliminary usability evaluation identified usability challenges that should be solved to allow real-world minimally-supervised use. Such a platform could complement conventional therapy, allowing to provide increased dose with the available resources, and establish a continuum of care that progressively increases therapy lead of the patient from the clinic to the home.