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).

Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study.

BACKGROUND: Increasing 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. OBJECTIVE: This 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. METHODS: Participants 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. RESULTS: As of April 2023, 13 patients were recruited and completed the protocol, with no reported adverse events. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT04388891; https://clinicaltrials.gov/study/NCT04388891. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48485.

Automatic and Personalized Adaptation of Therapy Parameters for Unsupervised Robot-Assisted Rehabilitation: a Pilot Evaluation.

Growing evidence shows that increasing the dose of upper limb therapy after stroke might improve functional outcomes and unsupervised robot-assisted therapy may be a solution to achieve such an increase without adding workload on therapists. However, most of existing robotic devices still need frequent supervision by trained personnel and are currently not designed or ready for unsupervised use. One reason for this is that most rehabilitation devices are not capable of delivering and adapting personalized therapy without external intervention. Here we present a set of clinically-inspired algorithms that automatically adapt therapy parameters in a personalized way and guide the course of robot-assisted therapy sessions. We implemented these algorithms on a robotic device for hand rehabilitation and tested them in a pilot study with 5 subacute stroke subjects over 10 robot-assisted therapy sessions, some of which unsupervised. Results show that our algorithms could adapt the therapy difficulty throughout the whole study without requiring external intervention, maintaining performance around a predefined 70% target value (mean performance for all the subjects over all the sessions: 64.5%). Moreover, the algorithms could guide patients through the therapy sessions, minimizing the number of actions that subjects had to learn and perform. These results open the door to the use of robotic devices in an unsupervised setting to increase therapy dose after stroke.

A Novel Mixed-Method Approach to Identify Needs and Requirements for Upper Limb Assistive Technology for Persons after Stroke.

Following stroke, a significant portion of individuals suffer from upper limb impairments and struggle with activities of daily living. Dedicated assistive technology (AT), such as robotic hand orthoses (RHO), can help facilitate upper limb usage and allow users to regain independence in their daily lives. Often, users' needs and requirements are neglected in AT design, thereby contributing to poor technology acceptance. In this work, we propose and apply a mixed-method focus group combining qualitative and quantitative components to gather user expectations in view of a user-centred redesign of a RHO. Three main themes emerged from a thematic analysis of two focus groups (n=5): Experience after stroke, desired design features, and reflections and realisations. Participants listed device features they would look for in AT and ranked them relative to what they deem important and necessary for a satisfactory device. Participants primarily looked for AT that is effective, intuitive and easy to use. These insights complement traditional technical design requirements for RHO by considering user desires, aspects unfortunately often neglected in the early design process. This work provides guidelines allowing for the optimization of AT design to better match the needs of persons after stroke and improve technology acceptance.

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.

Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot.

BACKGROUND: Selecting and maintaining an engaging and challenging training difficulty level in robot-assisted stroke rehabilitation remains an open challenge. Despite the ability of robotic systems to provide objective and accurate measures of function and performance, the selection and adaptation of exercise difficulty levels is typically left to the experience of the supervising therapist. METHODS: We introduce a patient-tailored and adaptive robot-assisted therapy concept to optimally challenge patients from the very first session and throughout therapy progress. The concept is evaluated within a four-week pilot study in six subacute stroke patients performing robot-assisted rehabilitation of hand function. Robotic assessments of both motor and sensory impairments of hand function conducted prior to the therapy are used to adjust exercise parameters and customize difficulty levels. During therapy progression, an automated routine adapts difficulty levels from session to session to maintain patients' performance around a target level of 70%, to optimally balance motivation and challenge. RESULTS: Robotic assessments suggested large differences in patients' sensorimotor abilities that are not captured by clinical assessments. Exercise customization based on these assessments resulted in an average initial exercise performance around 70% (62% ± 20%, mean ± std), which was maintained throughout the course of the therapy (64% ± 21%). Patients showed reduction in both motor and sensory impairments compared to baseline as measured by clinical and robotic assessments. The progress in difficulty levels correlated with improvements in a clinical impairment scale (Fugl-Meyer Assessment) (r s = 0.70), suggesting that the proposed therapy was effective at reducing sensorimotor impairment. CONCLUSIONS: Initial robotic assessments combined with progressive difficulty adaptation have the potential to automatically tailor robot-assisted rehabilitation to the individual patient. This results in optimal challenge and engagement of the patient, may facilitate sensorimotor recovery after neurological injury, and has implications for unsupervised robot-assisted therapy in the clinic and home environment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02096445.

Pure associative tactile agnosia for the left hand: clinical and anatomo-functional correlations.

Associative tactile agnosia (TA) is defined as the inability to associate information about object sensory properties derived through tactile modality with previously acquired knowledge about object identity. The impairment is often described after a lesion involving the parietal cortex (Caselli, 1997; Platz, 1996). We report the case of SA, a right-handed 61-year-old man affected by first ever right hemispheric hemorrhagic stroke. The neurological examination was normal, excluding major somaesthetic and motor impairment; a brain magnetic resonance imaging (MRI) confirmed the presence of a right subacute hemorrhagic lesion limited to the post-central and supra-marginal gyri. A comprehensive neuropsychological evaluation detected a selective inability to name objects when handled with the left hand in the absence of other cognitive deficits. A series of experiments were conducted in order to assess each stage of tactile recognition processing using the same stimulus sets: materials, 3D geometrical shapes, real objects and letters. SA and seven matched controls underwent the same experimental tasks during four sessions in consecutive days. Tactile discrimination, recognition, pantomime, drawing after haptic exploration out of vision and tactile-visual matching abilities were assessed. In addition, we looked for the presence of a supra-modal impairment of spatial perception and of specific difficulties in programming exploratory movements during recognition. Tactile discrimination was intact for all the stimuli tested. In contrast, SA was able neither to recognize nor to pantomime real objects manipulated with the left hand out of vision, while he identified them with the right hand without hesitations. Tactile-visual matching was intact. Furthermore, SA was able to grossly reproduce the global shape in drawings but failed to extract details of objects after left-hand manipulation, and he could not identify objects after looking at his own drawings. This case confirms the existence of selective associative TA as a left hand-specific deficit in recognizing objects. This deficit is not related to spatial perception or to the programming of exploratory movements. The cross-modal transfer of information via visual perception permits the activation of a partially degraded image, which alone does not allow the proper recognition of the initial tactile stimulus.

Problem in diagnostic radiology.

The case of a 58-year-old woman is described. She presented with what initially seemed to be a transient ischaemic attack. Clinical imaging, however,revealed an intracranial lipoma of the cisterna magna associated with a defect of the occipital bone and spina bifida occulta of the atlas.

Correlation between fatigue and brain atrophy and lesion load in multiple sclerosis patients independent of disability.

BACKGROUND: Fatigue is a major problem in multiple sclerosis (MS), and its association with MRI features is debated. OBJECTIVE: To study the correlation between fatigue and lesion load, white matter (WM), and grey matter (GM), in MS patients independent of disability. METHODS: We studied 222 relapsing remitting MS patients with low disability (scores or=5; n=197) and low-fatigue groups (FSS