The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke - protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab).

BACKGROUND: Body weight unloaded treadmill training has shown limited efficacy in further improving functional capacity after subacute rehabilitation of ischemic stroke patients. Dynamic robot assisted bodyweight unloading is a novel technology that may provide superior training stimuli and continued functional improvements in individuals with residual impairments in the chronic phase after the ischemic insult. The aim of the present study is to investigate the effect of dynamic robot-assisted versus standard training, initiated 6 months post-stroke, on motor function, physical function, fatigue, and quality of life in stroke-affected individuals still suffering from moderate-to-severe disabilities after subacute rehabilitation. METHODS: Stroke-affected individuals with moderate to severe disabilities will be recruited into a prospective cohort with measurements at 3-, 6-, 12- and 18-months post-stroke. A randomised controlled trial (RCT) will be nested in the prospective cohort with measurements pre-intervention (Pre), post-intervention (Post) and at follow-up 6 months following post-intervention testing. The present RCT will be conducted as a multicentre parallel-group superiority of intervention study with assessor-blinding and a stratified block randomisation design. Following pre-intervention testing, participants in the RCT study will be randomised into robot-assisted training (intervention) or standard training (active control). Participants in both groups will train 1:1 with a physiotherapist two times a week for 6 months (groups are matched for time allocated to training). The primary outcome is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment from pre-post intervention on the intention-to-treat population. A per-protocol analysis will be conducted analysing the differences in change scores of the participants demonstrating acceptable adherence. A priori sample size calculation allowing the detection of the minimally clinically important between-group difference of 6 points in the primary outcome (standard deviation 6 point, α = 5% and ß = 80%) resulted in 34 study participants. Allowing for dropout the study will include 40 participants in total. DISCUSSION: For stroke-affected individuals still suffering from moderate to severe disabilities following subacute standard rehabilitation, training interventions based on dynamic robot-assisted body weight unloading may facilitate an appropriate intensity, volume and task-specificity in training leading to superior functional recovery compared to training without the use of body weight unloading. TRIAL REGISTRATION: ClinicalTrials.gov. NCT06273475. TRIAL STATUS: Recruiting. Trial identifier: NCT06273475. Registry name: ClinicalTrials.gov. Date of registration on ClinicalTrials.gov: 22/02/2024.

Assistive technologies, including orthotic devices, for the management of contractures in adults after a stroke.

BACKGROUND: Contractures (reduced range of motion and increased stiffness of a joint) are a frequent complication of stroke. Contractures can interfere with function and cause cosmetic and hygiene problems. Preventing and managing contractures might improve rehabilitation and recovery after stroke. OBJECTIVES: To assess the effects of assistive technologies for the management of contractures in adults after a stroke. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers in May 2022. We also searched for reference lists of relevant studies, contacted experts in the field, and ran forward citation searches. SELECTION CRITERIA: Randomised controlled studies (RCTs) that used electrical, mechanical, or electromechanical devices to manage contractures in adults with stroke were eligible for inclusion in this review. We planned to include studies that compared assistive technologies against no treatment, routine therapy, or another assistive technology. DATA COLLECTION AND ANALYSIS: Three review authors (working in pairs) selected all studies, extracted data, and assessed risk of bias. The primary outcomes were passive joint range of motion (PROM) with and without standardised force, and indirect measures of PROM. The secondary outcomes included hygiene. We also wanted to evaluate the adverse effects of assistive technology. Effects were expressed as mean differences (MDs) or standardised mean differences (SMDs) with 95% confidence intervals (CIs). MAIN RESULTS: Seven studies fulfilled the inclusion criteria. Five of these were meta-analysed; they included 252 adults treated in acute and subacute rehabilitation settings. All studies compared assistive technology with routine therapy; one study also compared assistive technology with no treatment, but we were unable to obtain separate data for stroke participants. The assistive technologies used in the studies were electrical stimulation, splinting, positioning using a hinged board, and active repetitive motor training using a non-robotic device with electrical stimulation. Only one study applied stretching to end range. Treatment duration ranged from four to 12 weeks. The overall risk of bias was high for all studies. We are uncertain whether: • electrical stimulation to wrist extensors improves passive range of wrist extension (MD -7.30°, 95% CI -18.26° to 3.66°; 1 study, 81 participants; very low-certainty evidence); • a non-robotic device with electrical stimulation to shoulder flexors improves passive range of shoulder flexion (MD -9.00°, 95% CI -25.71° to 7.71°; 1 study; 50 participants; very low-certainty evidence); • assistive technology improves passive range of wrist extension with standardised force (SMD -0.05, 95% CI -0.39 to 0.29; four studies, 145 participants; very low-certainty evidence): • a non-robotic device with electrical stimulation to elbow extensors improves passive range of elbow extension (MD 0.41°, 95% CI -0.15° to 0.97°; 1 study, 50 participants; very low-certainty evidence). One study reported the adverse outcome of pain when using a hinged board to apply stretch to wrist and finger flexors, and another study reported skin breakdown when using a thumb splint. No studies reported hygiene or indirect measures of PROM. AUTHORS' CONCLUSIONS: Only seven small RCTs met the eligibility criteria of this review, and all provided very low-certainty evidence. Consequently, we cannot draw firm conclusions on the effects of assistive technology compared with routine therapy or no therapy. It was also difficult to confirm whether there is a risk of harm associated with treatment using assistive technology. Future studies should apply adequate treatment intensity (i.e. magnitude and the duration of stretch) and use valid and reliable outcome measures. Such studies might better identify the role of assistive technology in the management of contractures in adults after a stroke.

Application of immersive virtual reality mirror therapy for upper limb rehabilitation after stroke: a scoping review.

Mirror therapy is a commonly used rehabilitation intervention in post stroke upper limb rehabilitation. Despite many potential technological developments, mirror therapy is routinely delivered through the use of a static mirror or mirror box. This review aims to synthesise evidence on the application of immersive virtual reality mirror therapy (IVRMT) in poststroke upper limb rehabilitation. A scoping review was performed on relevant English studies published between 2013 to 2023. Literature search was undertaken on APA PsycInfo, CINAHL, Cochrane Library, MEDLINE, PubMed and Web of Science between August 5 and 17, 2023. Additional studies were included from Google Scholar and reference lists of identified articles. A total of 224 records were identified, of which 8 full-text articles were selected for review. All included studies were published between 2019 and 2023, and from high- and upper-middle-income nations. All the studies were experimental (n = 8). The total sample size in the studies was 259, most of whom were stroke patients with upper limb weakness (n = 184). This review identified three major themes and two sub-themes based on the contents of the studies conducted on the application of IVRMT: IVRMT's technical application, feasibility and impact on clinical outcomes (motor recovery and adverse events). IVRMT was concluded to be a safe and feasible approach to post-stroke upper limb rehabilitation, offering enhanced engagement and motor recovery. However, more methodologically robust studies should be conducted to advance this area of practice, and to include a uniform IVRMT intervention protocol, dose, and use of outcome measure.

Clinical validation of automated depth camera-based measurement of the Fugl-Meyer assessment for upper extremity.

OBJECTIVE: Depth camera-based measurement has demonstrated efficacy in automated assessment of upper limb Fugl-Meyer Assessment for paralysis rehabilitation. However, there is a lack of adequately sized studies to provide clinical support. Thus, we developed an automated system utilizing depth camera and machine learning, and assessed its feasibility and validity in a clinical setting. DESIGN: Validation and feasibility study of a measurement instrument based on single cross-sectional data. SETTING: Rehabilitation unit in a general hospital. PARTICIPANTS: Ninety-five patients with hemiparesis admitted for inpatient rehabilitation unit (2021-2023). MAIN MEASURES: Scores for each item, excluding those related to reflexes, were computed utilizing machine learning models trained on participant videos and readouts from force test devices, while the remaining reflex scores were derived through regression algorithms. Concurrent criterion validity was evaluated using sensitivity, specificity, percent agreement and Cohen's Kappa coefficient for ordinal scores of individual items, as well as correlations and intraclass correlation coefficients for total scores. Video-based manual assessment was also conducted and compared to the automated tools. RESULT: The majority of patients completed the assessment without therapist intervention. The automated scoring models demonstrated superior validity compared to video-based manual assessment across most items. The total scores derived from the automated assessment exhibited a high coefficient of 0.960. However, the validity of force test items utilizing force sensing resistors was relatively low. CONCLUSION: The integration of depth camera technology and machine learning models for automated Fugl-Meyer Assessment demonstrated acceptable validity and feasibility, suggesting its potential as a valuable tool in rehabilitation assessment.

CFI: a VR motor rehabilitation serious game design framework integrating rehabilitation function and game design principles with an upper limb case.

Virtual reality (VR) Rehabilitation holds the potential to address the challenge that patients feel bored and give up long-term rehabilitation training. Despite the introduction of gaming elements by some researchers in rehabilitation training to enhance engagement, there remains a notable lack of in-depth research on VR rehabilitation serious game design methods, particularly the absence of a concrete design framework for VR rehabilitation serious games. Hence, we introduce the Clinical-Function-Interesting (CFI): a VR rehabilitation serious game design framework, harmonizing rehabilitation function and game design theories. The framework initiates with clinic information, defining game functions through the functional decomposition of rehabilitation training. Subsequently, it integrates gaming elements identified through the analysis and comparison of related literature to provide enduring support for long-term training. Furthermore, VR side-effect and enhancement are considered. Building upon this design framework, we have developed an upper limb VR rehabilitation serious game tailored for mild to moderate stroke patients and aligned our framework with another developed VR rehabilitation serious game to validate its practical feasibility. Overall, the proposed design framework offers a systematic VR rehabilitation serious game design methodology for the VR rehabilitation field, assisting developers in more accurately designing VR rehabilitation serious games that are tailored to specific rehabilitation goals.

Enhancing stroke rehabilitation with whole-hand haptic rendering: development and clinical usability evaluation of a novel upper-limb rehabilitation device.

INTRODUCTION: There is currently a lack of easy-to-use and effective robotic devices for upper-limb rehabilitation after stroke. Importantly, most current systems lack the provision of somatosensory information that is congruent with the virtual training task. This paper introduces a novel haptic robotic system designed for upper-limb rehabilitation, focusing on enhancing sensorimotor rehabilitation through comprehensive haptic rendering. METHODS: We developed a novel haptic rehabilitation device with a unique combination of degrees of freedom that allows the virtual training of functional reach and grasp tasks, where we use a physics engine-based haptic rendering method to render whole-hand interactions between the patients' hands and virtual tangible objects. To evaluate the feasibility of our system, we performed a clinical mixed-method usability study with seven patients and seven therapists working in neurorehabilitation. We employed standardized questionnaires to gather quantitative data and performed semi-structured interviews with all participants to gain qualitative insights into the perceived usability and usefulness of our technological solution. RESULTS: The device demonstrated ease of use and adaptability to various hand sizes without extensive setup. Therapists and patients reported high satisfaction levels, with the system facilitating engaging and meaningful rehabilitation exercises. Participants provided notably positive feedback, particularly emphasizing the system's available degrees of freedom and its haptic rendering capabilities. Therapists expressed confidence in the transferability of sensorimotor skills learned with our system to activities of daily living, although further investigation is needed to confirm this. CONCLUSION: The novel haptic robotic system effectively supports upper-limb rehabilitation post-stroke, offering high-fidelity haptic feedback and engaging training tasks. Its clinical usability, combined with positive feedback from both therapists and patients, underscores its potential to enhance robotic neurorehabilitation.

Cross-step detection using center-of-pressure based algorithm for real-time applications.

BACKGROUND: Gait event detection is crucial for assessment, evaluation and provision of biofeedback during rehabilitation of walking. Existing online gait event detection algorithms mostly rely on add-on sensors, limiting their practicality. Instrumented treadmills offer a promising alternative by utilizing the Center of Pressure (CoP) signal for real-time gait event detection. However, current methods have limitations, particularly in detecting cross-step events during perturbed walking conditions. METHODS: We present and validate a CoP-based algorithm to detect gait events and cross-steps in real-time, which combines thresholding and logic techniques. The algorithm was evaluated on CoP datasets from healthy participants (age range 21-61 years), stroke survivors (age range 20-67 years), and people with unilateral transtibial amputation (age range 28-63 years) that underwent perturbation-based balance assessments, encompassing different walking speeds. Detected gait events from a simulated real-time processing operation were compared to offline identified counterparts in order to present related temporal absolute mean errors (AME) and success rate. RESULTS: The proposed algorithm demonstrated high accuracy in detecting gait events during native gait, as well as cross-step events during perturbed walking conditions. It successfully recognized the majority of cross-steps, with a detection success rate of 94%. However, some misclassifications or missed events occurred, mainly due to the complexity of cross-step events. AME for heel strikes (HS) during native gait and cross-step events averaged at 78 ms and 64 ms respectively, while toe off (TO) AME were 126 ms and 111 ms respectively. A statistically significant difference in the algorithm's success rate score in detecting gait events during cross-step intervals was observed across various walking speeds in a sample of 12 healthy participants, while there was no significant difference among groups. CONCLUSION: The proposed algorithm represents an advancement in gait event detection on instrumented treadmills. By leveraging the CoP signal, it successfully identifies gait events and cross-steps in the simulated real-time processing operation, providing valuable insights into human locomotion. The algorithm's ability to accommodate diverse CoP patterns enhance its applicability to a wide range of individuals and gait characteristics. The algorithm's performance was consistent across different populations, suggesting its potential for diverse clinical and research settings, particularly in the domains of gait analysis and rehabilitation practices.

Home-based guidance training system with interactive visual feedback using kinect on stroke survivors with moderate to severe motor impairment.

The home-based training approach benefits stroke survivors by providing them with an increased amount of training time and greater feasibility in terms of their training schedule, particularly for those with severe motor impairment. Computer-guided training systems provide visual feedback with correct movement patterns during home-based training. This study aimed to investigate the improvement in motor performance among stroke survivors with moderate to severe motor impairment after 800 min of training using a home-based guidance training system with interactive visual feedback. Twelve patients with moderate to severe stroke underwent home-based training, totaling 800 min (20-40 min per session, with a frequency of 3 sessions per week). The home-based guidance training system uses Kinect to reconstruct the 3D human body skeletal model and provides real-time motor feedback during training. The training exercises consisted of six core exercises and eleven optional exercises, including joint exercises, balance control, and coordination. Pre-training and post-training assessments were conducted using the Fugl-Meyer Assessment-Upper Limb (FMA-UE), Fugl-Meyer Assessment-Lower Limb (FMA-LE), Functional Ambulation Categories (FAC), Berg Balance Scale (BBS), Barthel Index (BI), Modified Ashworth Scale (MAS), as well as kinematic data of joint angles and center of mass (COM). The results indicated that motor training led to the attainment of the upper limit of functional range of motion (FROM) in hip abduction, shoulder flexion, and shoulder abduction. However, there was no improvement in the active range of motion (AROM) in the upper extremity (U/E) and lower extremity (L/E) joints, reaching the level of the older healthy population. Significant improvements were observed in both left/right and superior/inferior displacements, as well as body sway in the mediolateral axis of the COM, after 800 min of training. In conclusion, the home-based guidance system using Kinect aids in improving joint kinematics performance at the level of FROM and balance control, accompanied by increased mediolateral body sway of the COM for stroke survivors with moderate to severe stroke. Additionally, spasticity was reduced in both the upper and lower extremities after 800 min of home-based training.

The use of accelerometer bracelets to evaluate arm motor function over a stroke rehabilitation period - an explorative observational study.

BACKGROUND: Assessments of arm motor function are usually based on clinical examinations or self-reported rating scales. Wrist-worn accelerometers can be a good complement to measure movement patterns after stroke. Currently there is limited knowledge of how accelerometry correlate to clinically used scales. The purpose of this study was therefore to evaluate the relationship between intermittent measurements of wrist-worn accelerometers and the patient's progression of arm motor function assessed by routine clinical outcome measures during a rehabilitation period. METHODS: Patients enrolled in in-hospital rehabilitation following a stroke were invited. Included patients were asked to wear wrist accelerometers for 24 h at the start (T1) and end (T2) of their rehabilitation period. On both occasions arm motor function was assessed by the modified Motor Assessment Scale (M_MAS) and the Motor Activity Log (MAL). The recorded accelerometry was compared to M_MAS and MAL. RESULTS: 20 patients were included, of which 18 completed all measurements and were therefore included in the final analysis. The resulting Spearman's rank correlation coefficient showed a strong positive correlation between measured wrist acceleration in the affected arm and M-MAS and MAL values at T1, 0.94 (p < 0.05) for M_MAS and 0.74 (p < 0.05) for the MAL values, and a slightly weaker positive correlation at T2, 0.57 (p < 0.05) for M_MAS and 0.46 - 0.45 (p = 0.06) for the MAL values. However, no correlation was seen for the difference between the two sessions. CONCLUSIONS: The results confirm that the wrist acceleration can differentiate between the affected and non-affected arm, and that there is a positive correlation between accelerometry and clinical measures. Many of the patients did not change their M-MAS or MAL scores during the rehabilitation period, which may explain why no correlation was seen for the difference between measurements during the rehabilitation period. Further studies should include continuous accelerometry throughout the rehabilitation period to reduce the impact of day-to-day variability.

Post-stroke hand gesture recognition via one-shot transfer learning using prototypical networks.

BACKGROUND: In-home rehabilitation systems are a promising, potential alternative to conventional therapy for stroke survivors. Unfortunately, physiological differences between participants and sensor displacement in wearable sensors pose a significant challenge to classifier performance, particularly for people with stroke who may encounter difficulties repeatedly performing trials. This makes it challenging to create reliable in-home rehabilitation systems that can accurately classify gestures. METHODS: Twenty individuals who suffered a stroke performed seven different gestures (mass flexion, mass extension, wrist volar flexion, wrist dorsiflexion, forearm pronation, forearm supination, and rest) related to activities of daily living. They performed these gestures while wearing EMG sensors on the forearm, as well as FMG sensors and an IMU on the wrist. We developed a model based on prototypical networks for one-shot transfer learning, K-Best feature selection, and increased window size to improve model accuracy. Our model was evaluated against conventional transfer learning with neural networks, as well as subject-dependent and subject-independent classifiers: neural networks, LGBM, LDA, and SVM. RESULTS: Our proposed model achieved 82.2% hand-gesture classification accuracy, which was better (P<0.05) than one-shot transfer learning with neural networks (63.17%), neural networks (59.72%), LGBM (65.09%), LDA (63.35%), and SVM (54.5%). In addition, our model performed similarly to subject-dependent classifiers, slightly lower than SVM (83.84%) but higher than neural networks (81.62%), LGBM (80.79%), and LDA (74.89%). Using K-Best features improved the accuracy in 3 of the 6 classifiers used for evaluation, while not affecting the accuracy in the other classifiers. Increasing the window size improved the accuracy of all the classifiers by an average of 4.28%. CONCLUSION: Our proposed model showed significant improvements in hand-gesture recognition accuracy in individuals who have had a stroke as compared with conventional transfer learning, neural networks and traditional machine learning approaches. In addition, K-Best feature selection and increased window size can further improve the accuracy. This approach could help to alleviate the impact of physiological differences and create a subject-independent model for stroke survivors that improves the classification accuracy of wearable sensors. TRIAL REGISTRATION NUMBER: The study was registered in Chinese Clinical Trial Registry with registration number CHiCTR1800017568 in 2018/08/04.

Utility and usability of a wearable system and progressive-challenge cued exercise program for encouraging use of the more involved arm at-home after stroke-a feasibility study with case reports.

BACKGROUND: Understanding the role of adherence to home exercise programs for survivors of stroke is critical to ensure patients perform prescribed exercises and maximize effectiveness of recovery. METHODS: Survivors of hemiparetic stroke with impaired motor function were recruited into a 7-day study designed to test the utility and usability of a low-cost wearable system and progressive-challenge cued exercise program for encouraging graded-challenge exercise at-home. The wearable system comprised two wrist-worn MetaMotionR+ activity monitors and a custom smartphone app. The progressive-challenge cued exercise program included high-intensity activities (one repetition every 30 s) dosed at 1.5 h per day, embedded within 8 h of passive activity monitoring per day. Utility was assessed using measures of system uptime and cue response rate. Usability and user experience were assessed using well-validated quantitative surveys of system usability and user experience. Self-efficacy was assessed at the end of each day on a visual analog scale that ranged from 0 to 100. RESULTS: The system and exercise program had objective utility: system uptime was 92 ± 6.9% of intended hours and the rate of successful cue delivery was 99 ± 2.7%. The system and program also were effective in motivating cued exercise: activity was detected within 5-s of the cue 98 ± 3.1% of the time. As shown via two case studies, accelerometry data can accurately reflect graded-challenge exercise instructions and reveal differentiable activity levels across exercise stages. User experience surveys indicated positive overall usability in the home settings, strong levels of personal motivation to use the system, and high degrees of satisfaction with the devices and provided training. Self-efficacy assessments indicated a strong perception of proficiency across participants (95 ± 5.0). CONCLUSIONS: This study demonstrates that a low-cost wearable system providing frequent haptic cues to encourage graded-challenge exercise after stroke can have utility and can provide an overall positive user experience in home settings. The study also demonstrates how combining a graded exercise program with all-day activity monitoring can provide insight into the potential for wearable systems to assess adherence to-and effectiveness of-home-based exercise programs on an individualized basis.

Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation.

OBJECTIVE: The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., Korea, called the Gait Enhancing and Motivating System-Hip (GEMS-H), in assistance mode only with the poststroke population in an outpatient-rehabilitation setting. METHODS: Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6-8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation. RESULTS: By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device. CONCLUSIONS: Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov (NCT04285060).

Implementation of a unilateral hip flexion exosuit to aid paretic limb advancement during inpatient gait retraining for individuals post-stroke: a feasibility study.

BACKGROUND: During inpatient rehabilitation, physical therapists (PTs) often need to manually advance patients' limbs, adding physical burden to PTs and impacting gait retraining quality. Different electromechanical devices alleviate this burden by assisting a patient's limb advancement and supporting their body weight. However, they are less ideal for neuromuscular engagement when patients no longer need body weight support but continue to require assistance with limb advancement as they recover. The objective of this study was to determine the feasibility of using a hip flexion exosuit to aid paretic limb advancement during inpatient rehabilitation post-stroke. METHODS: Fourteen individuals post-stroke received three to seven 1-hour walking sessions with the exosuit over one to two weeks in addition to standard care of inpatient rehabilitation. The exosuit assistance was either triggered by PTs or based on gait events detected by body-worn sensors. We evaluated clinical (distance, speed) and spatiotemporal (cadence, stride length, swing time symmetry) gait measures with and without exosuit assistance during 2-minute and 10-meter walk tests. Sessions were grouped by the assistance required from the PTs (limb advancement and balance support, balance support only, or none) without exosuit assistance. RESULTS: PTs successfully operated the exosuit in 97% of sessions, of which 70% assistance timing was PT-triggered to accommodate atypical gait. Exosuit assistance eliminated the need for manual limb advancement from PTs. In sessions with participants requiring limb advancement and balance support, the average distance and cadence during 2-minute walk test increased with exosuit assistance by 2.2 ± 3.1 m and 3.4 ± 1.9 steps/min, respectively (p < 0.017). In sessions with participants requiring balance support only, the average speed during 10-meter walk test increased with exosuit by 0.07 ± 0.12 m/s (p = 0.042). Clinical and spatiotemporal measures of independent ambulators were similar with and without exosuit (p > 0.339). CONCLUSIONS: We incorporated a unilateral hip flexion exosuit into inpatient stroke rehabilitation in individuals with varying levels of impairments. The exosuit assistance removed the burden of manual limb advancement from the PTs and resulted in improved gait measures in some conditions. Future work will understand how to optimize controller and assistance profiles for this population.

Effect of robot-assisted gait training on improving cardiopulmonary function in stroke patients: a meta-analysis.

OBJECTIVE: Understanding the characteristics related to cardiorespiratory fitness after stroke can provide reference values for patients in clinical rehabilitation exercise. This meta- analysis aimed to investigate the effect of robot-assisted gait training in improving cardiorespiratory fitness in post-stroke patients, compared to conventional rehabilitation training. METHODS: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, CBM, CNKI and Wanfang databases were searched until March 18th, 2024. Randomized controlled trials (RCTs) comparing the effectiveness of robot-assisted gait training versus control group were included. The main outcome variable was peak oxygen uptake. 6-minute walking test, peak heart rate, peak inspiratory expiratory ratio as our secondary indicators. RevMan 5.3 software was used for statistical analysis. RESULTS: A total of 17 articles were included, involving 689 subjects. The results showed a significant effect for robot-assisted gait training to improve VO2peak (MD = 1.85; 95% CI: -0.13 to 3.57; p = 0.04) and 6WMT (MD = 19.26; 95% CI: 10.43 to 28.08; p < 0.0001). However, no significant difference favouring robot-assisted gait training were found in HRpeak (MD = 3.56; 95% CI: -1.90 to 9.02; p = 0.20) and RERpeak (MD = -0.01; 95% CI: -0.04 to 0.01; p = 0.34). CONCLUSION: These results showed that robot-assisted gait training may have a beneficial effect in improving VO2peak and 6WMT, with a moderate recommendation level according to the GRADE guidelines.

Exoskeleton rehabilitation robot training for balance and lower limb function in sub-acute stroke patients: a pilot, randomized controlled trial.

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.

Human-centered design of a novel soft exosuit for post-stroke gait rehabilitation.

BACKGROUND: Stroke remains a major cause of long-term adult disability in the United States, necessitating the need for effective rehabilitation strategies for post-stroke gait impairments. Despite advancements in post-stroke care, existing rehabilitation often falls short, prompting the development of devices like robots and exoskeletons. However, these technologies often lack crucial input from end-users, such as clinicians, patients, and caregivers, hindering their clinical utility. Employing a human-centered design approach can enhance the design process and address user-specific needs. OBJECTIVE: To establish a proof-of-concept of the human-centered design approach by refining the NewGait® exosuit device for post-stroke gait rehabilitation. METHODS: Using iterative design sprints, the research focused on understanding the perspectives of clinicians, stroke survivors, and caregivers. Two design sprints were conducted, including empathy interviews at the beginning of the design sprint to integrate end-users' insights. After each design sprint, the NewGait device underwent refinements based on emerging issues and recommendations. The final prototype underwent mechanical testing for durability, biomechanical simulation testing for clinical feasibility, and a system usability evaluation, where the new stroke-specific NewGait device was compared with the original NewGait device and a commercial product, Theratogs®. RESULTS: Affinity mapping from the design sprints identified crucial categories for stakeholder adoption, including fit for females, ease of donning and doffing, and usability during barefoot walking. To address these issues, a system redesign was implemented within weeks, incorporating features like a loop-backed neoprene, a novel closure mechanism for the shoulder harness, and a hook-and-loop design for the waist belt. Additional improvements included reconstructing anchors with rigid hook materials and replacing latex elastic bands with non-latex silicone-based bands for enhanced durability. Further, changes to the dorsiflexion anchor were made to allow for barefoot walking. Mechanical testing revealed a remarkable 10-fold increase in durability, enduring 500,000 cycles without notable degradation. Biomechanical simulation established the modularity of the NewGait device and indicated that it could be configured to assist or resist different muscles during walking. Usability testing indicated superior performance of the stroke-specific NewGait device, scoring 84.3 on the system usability scale compared to 62.7 for the original NewGait device and 46.9 for Theratogs. CONCLUSION: This study successfully establishes the proof-of-concept for a human-centered design approach using design sprints to rapidly develop a stroke-specific gait rehabilitation system. Future research should focus on evaluating the clinical efficacy and effectiveness of the NewGait device for post-stroke rehabilitation.

A new modular neuroprosthesis suitable for hybrid FES-robot applications and tailored assistance.

BACKGROUND: To overcome the application limitations of functional electrical stimulation (FES), such as fatigue or nonlinear muscle response, the combination of neuroprosthetic systems with robotic devices has been evaluated, resulting in hybrid systems that have promising potential. However, current technology shows a lack of flexibility to adapt to the needs of any application, context or individual. The main objective of this study is the development of a new modular neuroprosthetic system suitable for hybrid FES-robot applications to meet these needs. METHODS: In this study, we conducted an analysis of the requirements for developing hybrid FES-robot systems and reviewed existing literature on similar systems. Building upon these insights, we developed a novel modular neuroprosthetic system tailored for hybrid applications. The system was specifically adapted for gait assistance, and a technological personalization process based on clinical criteria was devised. This process was used to generate different system configurations adjusted to four individuals with spinal cord injury or stroke. The effect of each system configuration on gait kinematic metrics was analyzed by using repeated measures ANOVA or Friedman's test. RESULTS: A modular NP system has been developed that is distinguished by its flexibility, scalability and personalization capabilities. With excellent connection characteristics, it can be effectively integrated with robotic devices. Its 3D design facilitates fitting both as a stand-alone system and in combination with other robotic devices. In addition, it meets rigorous requirements for safe use by incorporating appropriate safety protocols, and features appropriate battery autonomy, weight and dimensions. Different technological configurations adapted to the needs of each patient were obtained, which demonstrated an impact on the kinematic gait pattern comparable to that of other devices reported in the literature. CONCLUSIONS: The system met the identified technical requirements, showcasing advancements compared to systems reported in the literature. In addition, it demonstrated its versatility and capacity to be combined with robotic devices forming hybrids, adapting well to the gait application. Moreover, the personalization procedure proved to be useful in obtaining various system configurations tailored to the diverse needs of individuals.

Customized passive-dynamic ankle-foot orthoses can improve walking economy and speed for many individuals post-stroke.

BACKGROUND: Passive-dynamic ankle-foot orthoses (PD-AFOs) are often prescribed to address plantar flexor weakness during gait, which is commonly observed after stroke. However, limited evidence is available to inform the prescription guidelines of PD-AFO bending stiffness. This study assessed the extent to which PD-AFOs customized to match an individual's level of plantar flexor weakness influence walking function, as compared to No AFO and their standard of care (SOC) AFO. METHODS: Mechanical cost-of-transport, self-selected walking speed, and key biomechanical variables were measured while individuals greater than six months post-stroke walked with No AFO, with their SOC AFO, and with a stiffness-customized PD-AFO. Outcomes were compared across these conditions using a repeated measures ANOVA or Friedman test (depending on normality) for group-level analysis and simulation modeling analysis for individual-level analysis. RESULTS: Twenty participants completed study activities. Mechanical cost-of-transport and self-selected walking speed improved with the stiffness-customized PD-AFOs compared to No AFO and SOC AFO. However, this did not result in a consistent improvement in other biomechanical variables toward typical values. In line with the heterogeneous nature of the post-stroke population, the response to the PD-AFO was highly variable. CONCLUSIONS: Stiffness-customized PD-AFOs can improve the mechanical cost-of-transport and self-selected walking speed in many individuals post-stroke, as compared to No AFO and participants' standard of care AFO. This work provides initial efficacy data for stiffness-customized PD-AFOs in individuals post-stroke and lays the foundation for future studies to enable consistently effective prescription of PD-AFOs for patients post-stroke in clinical practice. TRIAL REGISTRATION: NCT04619043.

Effectiveness of mixed reality-based rehabilitation on hands and fingers by individual finger-movement tracking in patients with stroke.

BACKGROUND: Mixed reality (MR) is helpful in hand training for patients with stroke, allowing them to fully submerge in a virtual space while interacting with real objects. The recognition of individual finger movements is required for MR rehabilitation. This study aimed to assess the effectiveness of updated MR-board 2, adding finger training for patients with stroke. METHODS: Twenty-one participants with hemiplegic stroke (10 with left hemiplegia and 11 with right hemiplegia; nine female patients; 56.7 ± 14.2 years of age; and onset of stroke 32.7 ± 34.8 months) participated in this study. MR-board 2 comprised a board plate, a depth camera, plastic-shaped objects, a monitor, a palm-worn camera, and seven gamified training programs. All participants performed 20 self-training sessions involving 30-min training using MR-board 2. The outcome measurements for upper extremity function were the Fugl-Meyer assessment (FMA) upper extremity score, repeated number of finger flexion and extension (Repeat-FE), the thumb opposition test (TOT), Box and Block Test score (BBT), Wolf Motor Function Test score (WMFT), and Stroke Impact Scale (SIS). One-way repeated measures analysis of variance and the post hoc test were applied for the measurements. MR-board 2 recorded the fingers' active range of motion (AROM) and Dunnett's test was used for pairwise comparisons. RESULTS: Except for the FMA-proximal score (p = 0.617) and TOT (p = 0.005), other FMA scores, BBT score, Repeat-FE, WMFT score, and SIS stroke recovery improved significantly (p < 0.001) during MR-board 2 training and were maintained until follow-up. All AROM values of the finger joints changed significantly during training (p < 0.001). CONCLUSIONS: MR-board 2 self-training, which includes natural interactions between humans and computers using a tangible user interface and real-time tracking of the fingers, improved upper limb function across impairment, activity, and participation. MR-board 2 could be used as a self-training tool for patients with stroke, improving their quality of life. TRIAL REGISTRATION NUMBER: This study was registered with the Clinical Research Information Service (CRIS: KCT0004167).

Efficacy of robot-assisted gait training on lower extremity function in subacute stroke patients: a systematic review and meta-analysis.

BACKGROUND: Robot-Assisted Gait Training (RAGT) is a novel technology widely employed in the field of neurological rehabilitation for patients with subacute stroke. However, the effectiveness of RAGT compared to conventional gait training (CGT) in improving lower extremity function remains a topic of debate. This study aimed to investigate and compare the effects of RAGT and CGT on lower extremity movement in patients with subacute stroke. METHODS: Comprehensive search was conducted across multiple databases, including PubMed, Web of Science, Cochrane Library, EBSCO, Embase, Scopus, China National Knowledge Infrastructure, Wan Fang, SinoMed and Vip Journal Integration Platform. The database retrieval was performed up until July 9, 2024. Meta-analysis was conducted using RevMan 5.4 software. RESULTS: A total of 24 RCTs were included in the analysis. The results indicate that, compared with CGT, RAGT led to significant improvements in the Fugl-Meyer Assessment for Lower Extremity [MD = 2.10, 95%CI (0.62, 3.59), P = 0.005], Functional Ambulation Category[MD = 0.44, 95%CI (0.23, 0.65), P < 0.001], Berg Balance Scale [MD = 4.55, 95%CI (3.00, 6.11), P < 0.001], Timed Up and Go test [MD = -4.05, 95%CI (-5.12, -2.98), P < 0.001], and 6-Minute Walk Test [MD = 30.66, 95%CI (22.36, 38.97), P < 0.001] for patients with subacute stroke. However, it did not show a significant effect on the 10-Meter Walk Test [MD = 0.06, 95%CI (-0.01, 0.14), P = 0.08]. CONCLUSIONS: This study provides evidence that RAGT can enhance lower extremity function, balance function, walking ability, and endurance levels compared to CGT. However, the quality of evidence for improvements in gait speed remains low.