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New developments, based on the concept of wearable soft-robotic devices, make it possible to support impaired hand function during the performance of daily activities and intensive task-specific training. The wearable soft-robotic ironHand glove is such a system that supports grip strength during the performance of daily activities and hand training exercises at home. This pilot randomized controlled clinical study explored the effect of prolonged use of the assistive ironHand glove during daily activities at home, in comparison to its use as a trainings tool at home, on functional performance of the hand. In total, 91 older adults with self-perceived decline of hand function participated in this study. They were randomly assigned to a 4-weeks intervention of either assistive or therapeutic ironHand use, or control group (received no additional exercise or treatment). All participants performed a maximal pinch grip test, Box and Blocks test (BBT), Jebsen-Taylor Hand Function Test (JTHFT) at baseline and after 4-weeks of intervention. Only participants of the assistive and therapeutic group completed the System Usability Scale (SUS) after the intervention period. Participants of the assistive and therapeutic group reported high scores on the SUS (mean = 73, SEM = 2). The therapeutic group showed improvements in unsupported handgrip strength (mean Δ = 3) and pinch strength (mean Δ = 0.5) after 4 weeks of ironHand use (p≤0.039). Scores on the BBT and JTHFT improved not only after 4 weeks of ironHand use (assistive and therapeutic), but also in the control group. Only handgrip strength improved more in the therapeutic group compared to the assistive and control group. No significant correlations were found between changes in performance and assistive or therapeutic ironHand use (p≥0.062). This study showed that support of the wearable soft-robotic ironHand system either as assistive device or as training tool may be a promising way to counter functional hand function decline associated with ageing.

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

Robot-assisted isokinetic training has been widely adopted for knee rehabilitation. However, existing rehabilitation facilities are often heavy, bulky, and extremely energy-consuming, which limits the rehabilitation opportunities only at designated hospitals. In this study, we introduce a highly integrated and lightweight (52 kg) knee rehabilitation robot that can provide home-based isokinetic training without external power. By integrating a motor, torque/angle sensors, control circuit, and energy regeneration circuit into a single driver module, our robot can provide power-free isokinetic training by recycling mechanical work from the trainee. Ten postsurgical subjects were involved in an interventional randomized trial (ChiCTR2300076715, Part I) and the cross-sectional area of trained legs (experimental group) was significantly higher than that of untrained legs (control group). The primary outcomes, muscle growth (quadriceps: 5.93%, hamstrings: 10.27%) and strength improvements (quadriceps: 70%, hamstrings: 84%), achieved with our robots surpass those of existing commercial rehabilitation devices. These findings indicate that our robot presents a viable option for home-based knee rehabilitation, significantly enhancing the accessibility of effective treatment. Existing isokinetic training devices are often heavy, bulky, and energy-consuming, which limits the rehabilitation opportunities only at designated hospitals. Here, the authors show a highly integrated and power-free knee rehabilitation robot that can provide home-based isokinetic training

The aim of this study is to present a robot-assisted therapy protocol for children with ASD based on the current state-of-the-art in both ASD intervention research and robotics research, and critically evaluate its adherence and acceptability based on child as well as parent ratings. The robot-assisted therapy was designed based on motivational components of Pivotal Response Treatment (PRT), a highly promising and feasible intervention focused at training “pivotal” (key) areas such as motivation for social interaction and self-initiations, with the goal of establishing collateral gains in untargeted areas of functioning and development, affected by autism spectrum disorders. Overall, children (3–8 y) could adhere to the robot-assisted therapy protocol (Mean percentage of treatment adherence 85.5%), showed positive affect ratings after therapy sessions (positive in 86.6% of sessions) and high robot likability scores (high in 79.4% of sessions). Positive likability ratings were mainly given by school-aged children ( H (1) = 7.91, p  = .005) and related to the movements, speech and game scenarios of the robot. Parent ratings on the added value of the robot were mainly positive (Mean of 84.8 on 0–100 scale), while lower parent ratings were related to inflexibility of robot behaviour.

Building on the notion that people respond to media as if they were real, switching off a robot which exhibits lifelike behavior implies an interesting situation. In an experimental lab study with a 2x2 between-subjects-design (N = 85), people were given the choice to switch off a robot with which they had just interacted. The style of the interaction was either social (mimicking human behavior) or functional (displaying machinelike behavior). Additionally, the robot either voiced an objection against being switched off or it remained silent. Results show that participants rather let the robot stay switched on when the robot objected. After the functional interaction, people evaluated the robot as less likeable, which in turn led to a reduced stress experience after the switching off situation. Furthermore, individuals hesitated longest when they had experienced a functional interaction in combination with an objecting robot. This unexpected result might be due to the fact that the impression people had formed based on the task-focused behavior of the robot conflicted with the emotional nature of the objection.

Purpose This pilot study aimed to investigate the effects of REX exoskeleton rehabilitation robot training on the balance and lower limb function in patients with sub-acute stroke. Methods This was a pilot, single-blind, randomized controlled trial. Twenty-four patients with sub-acute stroke (with the course of disease ranging from 3 weeks to 3 months) were randomized into two groups, including a robot group and a control group. Patients in control group received upright bed rehabilitation ( n  = 12) and those in robot group received exoskeleton rehabilitation robot training ( n  = 12). The frequency of training in both groups was once a day (60 min each) for 5 days a week for a total of 4 weeks. Besides, the two groups were evaluated before, 2 weeks after and 4 weeks after the intervention, respectively. The primary assessment index was the Berg Balance Scale (BBS), whereas the secondary assessment indexes included the Fugl-Meyer Lower Extremity Motor Function Scale (FMA-LE), the Posture Assessment Scale for Stroke Patients (PASS), the Activities of Daily Living Scale (Modified Barthel Index, MBI), the Tecnobody Balance Tester, and lower extremity muscle surface electromyography (sEMG). Results The robot group showed significant improvements ( P  < 0.05) in the primary efficacy index BBS, as well as the secondary efficacy indexes PASS, FMA-LE, MBI, Tecnobody Balance Tester, and sEMG of the lower limb muscles. Besides, there were a significant differences in BBS, PASS, static eye-opening area or dynamic stability limit evaluation indexes between the robotic and control groups ( P  < 0.05). Conclusions This is the first study to investigate the effectiveness of the REX exoskeleton rehabilitation robot in the rehabilitation of patients with stroke. According to our results, the REX exoskeleton rehabilitation robot demonstrated superior potential efficacy in promoting the early recovery of balance and motor functions in patients with sub-acute stroke. Future large-scale randomized controlled studies and follow-up assessments are needed to validate the current findings. Clinical trials registration URL: https://www.chictr.org.cn/index.html.Unique identifier: ChiCTR2300068398.

Background Impaired balance and gait in stroke survivors are associated with decreased functional independence. This study aimed to evaluate the effectiveness of unilateral lower-limb exoskeleton robot-assisted overground gait training compared with conventional treatment and to explore the relationship between neuroplastic changes and motor function recovery in subacute stroke patients. Methods In this randomized, single-blind clinical trial, 40 patients with subacute stroke were recruited and randomly assigned to either a robot-assisted training (RT) group or a conventional training (CT) group. All outcome measures were assessed at the enrollment baseline (T0), 2nd week (T1) and 4th week (T2) of the treatment. The primary outcome was the between-group difference in the change in the Berg balance scale (BBS) score from baseline to T2. The secondary measures included longitudinal changes in the Fugl-Meyer assessment of the lower limb (FMA-LE), modified Barthel index (mBI), functional ambulation category (FAC), and locomotion assessment with gait analysis. In addition, the cortical activation pattern related to robot-assisted training was measured before and after intervention via functional near-infrared spectroscopy. Results A total of 30 patients with complete data were included in this study. Clinical outcomes improved after 4 weeks of training in both groups, with significantly better BBS (F = 6.341, p  = 0.018, partial η2 = 0.185), FMA-LE (F = 5.979, p  = 0.021, partial η2 = 0.176), FAC (F = 7.692, p  = 0.010, partial η2 = 0.216), and mBI scores (F = 7.255, p  = 0.042, partial η2 = 0.140) in the RT group than in the CT group. Both groups showed significant improvement in gait speed and stride cadence on the locomotion assessment. Only the RT group presented a significantly increased stride length (F = 4.913, p  = 0.015, partial η2 = 0.267), support phase (F = 5.335, p  = 0.011, partial η2 = 0.283), and toe-off angle (F = 3.829, p  = 0.035, partial η2 = 0.228) on the affected side after the intervention. The RT group also showed increased neural activity response over the ipsilesional motor area and bilateral prefrontal cortex during robot-assisted weight-shift and gait training following 4 weeks of treatment. Conclusions Overground gait training with a unilateral exoskeleton robot showed improvements in balance and gait functions, resulting in better gait patterns and increased gait stability for stroke patients. The increased cortical response related to the ipsilesional motor areas and their related functional network is crucial in the rehabilitation of lower limb gait in post-stroke patients.

Recent literature emphasizes the importance of comfort in the design of exosuits and other assistive devices that physically augment humans; however, there is little quantitative data to aid designers in determining what level of force makes users uncomfortable. To help close this knowledge gap, we characterized human comfort limits when applying forces to the shoulders, thigh and shank. Our objectives were: (i) characterize the comfort limits for multiple healthy participants, (ii) characterize comfort limits across days, and (iii) determine if comfort limits change when forces are applied at higher vs. lower rates. We performed an experiment (N = 10) to quantify maximum tolerable force pulling down on the shoulders, and axially along the thigh and shank; we termed this force the comfort limit. We applied a series of forces of increasing magnitude, using a robotic actuator, to soft sleeves around their thigh and shank, and to a harness on their shoulders. Participants were instructed to press an off-switch, immediately removing the force, when they felt uncomfortable such that they did not want to feel a higher level of force. On average, participants exhibited comfort limits of ~0.9-1.3 times body weight on each segment: 621±245 N (shoulders), 867±296 N (thigh), 702±220 N (shank), which were above force levels applied by exosuits in prior literature. However, individual participant comfort limits varied greatly (~250-1200 N). Average comfort limits increased over multiple days (p<3e-5), as users habituated, from ~550-700 N on the first day to ~650-950 N on the fourth. Specifically, comfort limits increased 20%, 35% and 22% for the shoulders, thigh and shank, respectively. Finally, participants generally tolerated higher force when it was applied more rapidly. These results provide initial benchmarks for exosuit designers and end-users, and pave the way for exploring comfort limits over larger time scales, within larger samples and in different populations.

Background Over 80% of patients with stroke experience finger grasping dysfunction, affecting independence in activities of daily living and quality of life. In routine training, task-oriented training is usually used for functional hand training, which may improve finger grasping performance after stroke, while augmented therapy may lead to a better treatment outcome. As a new technology-supported training, the hand rehabilitation robot provides opportunities to improve the therapeutic effect by increasing the training intensity. However, most hand rehabilitation robots commonly applied in clinics are based on a passive training mode and lack the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. A force feedback hand rehabilitation robot can compensate for these defects. However, its clinical efficacy in patients with stroke remains unknown. This study aimed to investigate the effectiveness and added value of a force feedback hand rehabilitation robot combined with task-oriented training in stroke patients with hemiplegia. Methods In this single-blinded randomised controlled trial, 44 stroke patients with hemiplegia were randomly divided into experimental ( n  = 22) and control ( n  = 22) groups. Both groups received 40 min/day of conventional upper limb rehabilitation training. The experimental group received 20 min/day of task-oriented training assisted by a force feedback rehabilitation robot, and the control group received 20 min/day of task-oriented training assisted by therapists. Training was provided for 4 weeks, 5 times/week. The Fugl-Meyer motor function assessment of the hand part (FMA-Hand), Action Research Arm Test (ARAT), grip strength, Modified Ashworth scale (MAS), range of motion (ROM), Brunnstrom recovery stages of the hand (BRS-H), and Barthel index (BI) were used to evaluate the effect of two groups before and after treatment. Results Intra-group comparison: In both groups, the FMA-Hand, ARAT, grip strength, AROM, BRS-H, and BI scores after 4 weeks of treatment were significantly higher than those before treatment ( p  < 0.05), whereas there was no significant difference in finger flexor MAS scores before and after treatment ( p  > 0.05). Inter-group comparison: After 4 weeks of treatment, the experimental group’s FMA-Hand total score, ARAT, grip strength, and AROM were significantly better than those of the control group ( p  < 0.05). However, there were no statistically significant differences in the scores of each sub-item of the FMA-Hand after Bonferroni correction ( p  > 0.007). In addition, there were no statistically significant differences in MAS, BRS-H, and BI scores ( p  > 0.05). Conclusion Hand performance improved in patients with stroke after 4 weeks of task-oriented training. The use of a force feedback hand rehabilitation robot to support task-oriented training showed additional value over conventional task-oriented training in stroke patients with hand dysfunction. Clinical trial registration information NCT05841108

Background Gait disorder remains a major challenge for individuals with stroke, affecting their quality of life and increasing the risk of secondary complications. Robot-assisted gait training (RAGT) has emerged as a promising approach for improving gait independence in individuals with stroke. This study aimed to evaluate the effect of RAGT in individuals with subacute hemiparetic stroke using a one-leg assisted gait robot called Welwalk WW-1000. Methods An assessor-blinded, multicenter randomized controlled trial was conducted in the convalescent rehabilitation wards of eight hospitals in Japan. Participants with first-ever hemiparetic stroke who could not walk at pre-intervention assessment were randomized to either the Welwalk group, which underwent RAGT with conventional physical therapy, or the control group, which underwent conventional physical therapy alone. Both groups received 80 min of physical therapy per day, 7 days per week, while the Welwalk group received 40 min of RAGT per day, 6 days per week, as part of their physical therapy. The primary outcome was gait independence, as assessed using the Functional Independence Measure Walk Score. Results A total of 91 participants were enrolled, 85 of whom completed the intervention. As a result, 91 participants, as a full analysis set, and 85, as a per-protocol set, were analyzed. The primary outcome, the cumulative incidence of gait-independent events, was not significantly different between the groups. Subgroup analysis revealed that the interaction between the intervention group and stroke type did not yield significant differences in either the full analysis or per-protocol set. However, although not statistically significant, a discernible trend toward improvement with Welwalk was observed in cases of cerebral infarction for the full analysis and per-protocol sets (HR 4.167 [95%CI 0.914–18.995], p  = 0.065, HR 4.443 [95%CI 0.973–20.279], p  = 0.054, respectively). Conclusions The combination of RAGT using Welwalk and conventional physical therapy was not significantly more effective than conventional physical therapy alone in promoting gait independence in individuals with subacute hemiparetic stroke, although a trend toward earlier gait independence was observed in individuals with cerebral infarction. Trial registration This study was registered with the Japan Registry of Clinical Trials ( https://jrct.niph.go.jp ; jRCT 042180078) on March 3, 2019.