Feedback control of heart rate during robotics-assisted tilt table exercise in patients after stroke: a clinical feasibility study.

BACKGROUND: Patients with neurological disorders including stroke use rehabilitation to improve cognitive abilities, to regain motor function and to reduce the risk of further complications. Robotics-assisted tilt table technology has been developed to provide early mobilisation and to automate therapy involving the lower limbs. The aim of this study was to evaluate the feasibility of employing a feedback control system for heart rate (HR) during robotics-assisted tilt table exercise in patients after a stroke. METHODS: This feasibility study was designed as a case series with 12 patients ( n = 12 ) with no restriction on the time post-stroke or on the degree of post-stroke impairment severity. A robotics-assisted tilt table was augmented with force sensors, a work rate estimation algorithm, and a biofeedback screen that facilitated volitional control of a target work rate. Dynamic models of HR response to changes in target work rate were estimated in system identification tests; nominal models were used to calculate the parameters of feedback controllers designed to give a specified closed-loop bandwidth; and the accuracy of HR control was assessed quantitatively in feedback control tests. RESULTS: Feedback control tests were successfully conducted in all 12 patients. Dynamic models of heart rate response to imposed work rate were estimated with a mean root-mean-square (RMS) model error of 2.16 beats per minute (bpm), while highly accurate feedback control of heart rate was achieved with a mean RMS tracking error (RMSE) of 2.00 bpm. Control accuracy, i.e. RMSE, was found to be strongly correlated with the magnitude of heart rate variability (HRV): patients with a low magnitude of HRV had low RMSE, i.e. more accurate HR control performance, and vice versa. CONCLUSIONS: Feedback control of heart rate during robotics-assisted tilt table exercise was found to be feasible. Future work should investigate robustness aspects of the feedback control system. Modifications to the exercise modality, or alternative modalities, should be explored that allow higher levels of work rate and heart rate intensity to be achieved.

Automatic rehabilitation exercise task assessment of stroke patients based on wearable sensors with a lightweight multichannel 1D-CNN model.

Approximately 75% of stroke survivors have movement dysfunction. Rehabilitation exercises are capable of improving physical coordination. They are mostly conducted in the home environment without guidance from therapists. It is impossible to provide timely feedback on exercises without suitable devices or therapists. Human action quality assessment in the home setting is a challenging topic for current research. In this paper, a low-cost HREA system in which wearable sensors are used to collect upper limb exercise data and a multichannel 1D-CNN framework is used to automatically assess action quality. The proposed 1D-CNN model is first pretrained on the UCI-HAR dataset, and it achieves a performance of 91.96%. Then, five typical actions were selected from the Fugl-Meyer Assessment Scale for the experiment, wearable sensors were used to collect the participants' exercise data, and experienced therapists were employed to assess participants' exercise at the same time. Following the above process, a dataset was built based on the Fugl-Meyer scale. Based on the 1D-CNN model, a multichannel 1D-CNN model was built, and the model using the Naive Bayes fusion had the best performance (precision: 97.26%, recall: 97.22%, F1-score: 97.23%) on the dataset. This shows that the HREA system provides accurate and timely assessment, which can provide real-time feedback for stroke survivors' home rehabilitation.

Clinical application research of intelligent monitoring system for knee rehabilitation: a randomized controlled trial.

BACKGROUND: This study investigates the effectiveness of a self-developed intelligent monitoring system for home-based knee rehabilitation following total knee arthroplasty (TKA). METHODS: In this randomized controlled trial, 120 patients undergoing TKA were divided using random digit allocation. Preoperative and one-month postoperative assessments of knee function, quality of life, and isometric knee extension strength were conducted with the Intelligent Monitoring System. Patients received group-specific rehabilitation instructions pre-discharge and performed exercises for one month. RESULTS: Changes in isometric knee extensor strength on the affected side within one month post-surgery for the brace-monitored rehabilitation group showed a significant decrease three days after surgery compared to one day before surgery. Subsequent measurements taken at postoperative days 5, 7, 14, and 21 indicated a gradual increase in strength, although these increases did not reach statistical significance when compared with previous measurements. One month post-surgery, all groups demonstrated significant improvements in knee joint function and mobility compared to pre-surgery levels. Notably, the brace-monitored group showed statistically significant improvements in 36-Item Short-Form Health Survey (SF-36) scores over the conventional rehabilitation group. CONCLUSIONS: The Intelligent Monitoring System provides effective real-time monitoring and guidance for home-based knee rehabilitation post-TKA. It significantly enhances knee joint function, isometric knee extension strength, and quality of life shortly after surgery compared to traditional rehabilitation methods. This system offers a promising approach for improving postoperative recovery in TKA patients. TRIAL REGISTRATION: This study was approved by the Medical Ethics Committee of Xiangya Hospital, Central South University (Ethics Approval Number 202209008-2). It was registered with the China Clinical Trial Registry, a primary registry of the World Health Organization's International Clinical Trials Registry Platform (Registration Number ChiCTR2300068852).

Implementation and Evaluation of a Gait Training Assistant for the Use of Crutches: Usability Study.

BACKGROUND: Surgical procedures on the lower extremities often require weight-bearing on crutches as part of the rehabilitation process. Orthopedic elective procedures enable patients to learn the correct use of crutches in a controlled preoperative setting. Digital assistance systems can safely circumvent a shortage of skilled staff and any contact restrictions that may be necessary. OBJECTIVE: The usability of a newly developed gait training assistant (GTA) for the use of crutches will be evaluated. An intervention group trained to use crutches by the digital trainer will be compared with a control group trained to use crutches conventionally by a physiotherapist. METHODS: As part of the development and implementation of a novel GTA, 14 patients learned to walk with crutches by completing specific exercises while receiving live feedback. Their movements were detected by a depth sensor and evaluated in real time. Specific parameters (step length, synchronous movement, crutch angle, and crutch distance to the feet) were compared with a control group (n=14) trained to use crutches by physiotherapists. The intervention group was also assessed by a physiotherapist. At the end of the study, the patients completed questionnaires to evaluate the usability of the system (Brooke's System Usability Scale score) and patient satisfaction. RESULTS: All patients trained by the novel GTA were able to use crutches correctly. The intervention group showed significantly better values for crutch angle (mean -6.3°, SD 3.5° vs mean -12.4°, SD 4.5°; P<.001) and crutch position (mean 3.3, SD 5.1 cm vs mean -8.5, SD 4.9 cm; P=.02). Both groups reported that they felt confident in the use of crutches, were able to follow the instructions, and enjoyed the training. Even though the majority (12/14, 86%) preferred physical therapy over a purely digital approach, most participants enjoyed using the system (13/14, 93%) and were interested in trying out other digital assistants (11/14, 79%). The usability of the GTA was rated above average by the majority (9/14, 64%) of the patients. CONCLUSIONS: The newly designed GTA is a safe method of teaching the use of crutches and is statistically superior to training by a physiotherapist. Even if patients prefer interaction with a physiotherapist over a purely digital approach, digital devices provide a safe and motivating opportunity to learn the essential locomotor skills for rehabilitation.

A Digital Platform for Home-Based Exercise Prescription for Older People with Sarcopenia.

Digital therapeutics refers to smartphone applications, software, and wearable devices that provide digital solutions to improve healthcare delivery. We developed a digital platform to support the GYM (Grow Your Muscle) study, an ongoing 48-week randomized, controlled trial on reduction of sarcopenia through a home-based, app-monitored physical exercise intervention. The GYM platform consists of a smartphone application including the exercise program and video tutorials of body-weight exercises, a wearable device to monitor heart rate during training, and a website for downloading training data to remotely monitor the exercise. The aim of this paper is to describe the platform in detail and to discuss the technical issues emerging during the study and those related to usability of the smartphone application through a retrospective survey. The main technical issue concerned the API level 33 upgrade, which did not enable participants using the Android operating systems to use the wearable device. The survey revealed some problems with viewing the video tutorials and with internet or smartphone connection. On the other hand, the smartphone application was reported to be easy to use and helpful to guide home exercising. Despite the issues encountered during the study, this digital-supported physical exercise intervention could provide useful to improve muscle measures of sarcopenia.

Evaluating the efficacy of wearable biofeedback on the outcomes of exercise interventions in people with chronic non-specific spinal pain: protocol for a systematic review and meta-analysis.

INTRODUCTION: Wearable neuromuscular and biomechanical biofeedback technology has the potential to improve patient outcomes by facilitating exercise interventions. We will conduct a systematic review to examine whether the addition of wearable biofeedback to exercise interventions improves pain, disability and quality of life beyond exercise alone for adults with chronic non-specific spinal pain. Specific effects on clinical, physiological, psychological, exercise adherence and safety outcomes will also be examined. METHODS AND ANALYSIS: A systematic search will be conducted from inception to February 2024. Full articles in the English language will be included. MEDLINE, PubMed, CINAHL, EMBASE, Web of Science, PsycINFO, AMED, SPORTDiscus, CENTRAL databases, clinical trial registries and ProQuest (PQDT) will be used to search for eligible studies. Grey literature and conference proceedings (2022-2024) will be searched for relevant reports. Randomised controlled trials using wearable neuromuscular or kinematic biofeedback devices as an adjunct to exercise interventions for the treatment of chronic spinal pain will be included in this systematic review. The comparators will be wearable biofeedback with exercise versus exercise alone, or wearable biofeedback with exercise versus placebo and exercise. Risk of bias will be assessed using Cochrane Back Review Group criteria and the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation recommendations. ETHICS AND DISSEMINATION: The systematic review will be based on published studies, and therefore, does not require ethical approval. The study results will be submitted for publication in an international, open-access, peer-reviewed journal and shared through conferences and public engagement. PROSPERO REGISTRATION NUMBER: CRD42023481393.

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.

The effect of balance training using touch controller-based fully immersive virtual reality devices on balance and walking ability in patients with stroke: A pilot randomized controlled trial.

BACKGROUND: Fully immersive virtual reality (FIVR) removes information from the real world and replaces it with computer-generated data, creating the impression of being in a genuine virtual world. OBJECTIVE: To evaluate the effects of balance training using touch controller-based FIVR devices on balance and walking abilities in patients with stroke. METHODS: The participants were randomly categorized into the FIVR group (n = 18) and control group (n = 18). The control group received conventional therapy for 5 sessions, 30 minutes per week, for 5 weeks. The FIVR group practiced additional touch controller-based FIVR balance training for 3 sessions of 30 minutes per week for 5 weeks and changes in balance and walking ability were measured for both groups. RESULTS: Touch controller-based FIVR balance training significantly improved the Berg Balance Scale (BBS) and, timed up-and-go (TUG) test results (P < .01). There was also significant improvement in gait abilities, including gait velocity, step length of the affected side, stride length, and single limb support of the affected side (P < .01). CONCLUSION: Touch controller-based FIVR balance training improved balance and gait in patients with stroke. These results indicate that touch controller-based FIVR balance training is feasible and suitable for patients with stroke, providing a promising avenue for rehabilitation.

A randomized cross-over study protocol to evaluate long-term gait training with a pediatric robotic exoskeleton outside the clinical setting in children with movement disorders.

Individuals with neuromuscular disorders display a combination of motor control deficits and lower limb weakness contributing to knee extension deficiency characterized by exaggerated stance phase knee flexion. There is a lack of evidence for long-term improvement of knee extension deficiency with currently available clinical treatment programs. Our previous work testing a wearable robotic exoskeleton with precisely timed assistive torque applied at the knee showed immediate increases in knee extension during walking for children with cerebral palsy, which continued to improve over an acute practice period. When we applied interleaved assistance and resistance to knee extension, we observed improvements in knee extension and increased muscle activation indicating the potential for muscle strengthening when used over time. There is a need for additional, high-quality trials to assess the impact of dosage, intensity and volume of training necessary to see persistent improvement in lower limb function for these patient populations. This randomized crossover study (ClinicalTrials.gov: NCT05726591) was designed to determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting, following an initial in clinic accommodation period, has a beneficial effect on walking ability, muscle activity and overall motor function. Participants will be randomized to either complete the exoskeleton intervention or continue their standard therapy for 12 weeks first, followed by a crossover to the other study component. The primary outcome measure is change in peak knee extension angle during walking; secondary outcome measures include gait speed, strength, and validated clinical scales of motor function and mobility. Assessments will be completed before and after the intervention and at 6 weeks post-intervention, and safety and compliance will be monitored throughout. We hypothesize that the 12-week exoskeleton intervention outside the clinical setting will show greater improvements in study outcome measures than the standard therapy.

Treatment with robot-assisted gait trainer Walkbot along with physiotherapy vs. isolated physiotherapy in children and adolescents with cerebral palsy. Experimental study.

BACKGROUND: Improving walking ability is a key objective in the treatment of children and adolescents with cerebral palsy, since it directly affects their activity and participation. In recent years, robotic technology has been implemented in gait treatment, which allows training of longer duration and repetition of the movement. To know the effectiveness of a treatment with the robotic-assisted gait trainer Walkbot combined with physiotherapy compared to the isolated physiotherapy treatment in children and adolescents with cerebral palsy, we carried out a clinical trial. METHODS: 23 participants, were divided into two groups: experimental and control. During 5 weeks, both groups received their physiotherapy sessions scheduled, in addition experimental group received 4 sessions per week of 40 min of robot. An evaluation of the participants was carried out before the intervention, at the end of the intervention, and at follow-up (two months after the end of the intervention). Gait was assessed with the Gross Motor Function Measure-88 dimensions D and E, strength was measured with a hydraulic dynamometer, and range of motion was assessed using the goniometer. A mixed ANOVA was performed when the assumptions of normality and homoscedasticity were met, and a robust mixed ANOVA was performed when these assumptions were not met. Statistical significance was stipulated at p < 0.05. For the effect size, η2 was calculated. RESULTS: Significant differences were found regarding the time x group interaction in the Gross Motor Function Measure-88 in dimension D [η2 = 0.016], in the flexion strength of the left [η2 = 0.128] and right [η2 = 0.142] hips, in the extension strength of the right hip [η2 = 0.035], in the abduction strength of the left hip [η2 = 0.179] and right [η2 = 0.196], in the flexion strength of the left knee [η2 = 0.222] and right [η2 = 0.147], and in the range of motion of left [η2 = 0.071] and right [η2 = 0.053] knee flexion. CONCLUSIONS: Compared to treatments without walking robot, physiotherapy treatment including Walkbot improves standing, muscle strength, and knee range of motion in children and adolescents with cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04329793. First posted: April 1, 2020.

Overground Gait Training With a Wearable Robot in Children With Cerebral Palsy: A Randomized Clinical Trial.

Importance: Cerebral palsy (CP) is the most common developmental motor disorder in children. Robot-assisted gait training (RAGT) using a wearable robot can provide intensive overground walking experience. Objective: To investigate the effectiveness of overground RAGT in children with CP using an untethered, torque-assisted, wearable exoskeletal robot. Design, Setting, and Participants: This multicenter, single-blind randomized clinical trial was conducted from September 1, 2021, to March 31, 2023, at 5 rehabilitation institutions in Korea. Ninety children with CP in Gross Motor Function Classification System levels II to IV were randomized. Intervention: The RAGT group underwent 18 sessions of RAGT during 6 weeks, whereas the control group received standard physical therapy for the same number of sessions during the same period. Main Outcome and Measures: The primary outcome measure was the Gross Motor Function Measure 88 (GMFM-88) score. Secondary outcome measures were the GMFM-66, Pediatric Balance Scale, selective control assessment of the lower extremity, Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), 6-minute walking test scores (distance and oxygen consumption), muscle and fat mass via bioelectrical impedance analysis, and gait parameters measured via 3-dimensional analysis. All assessments were performed for all patients at baseline, at the end of the 6-week intervention, and after the 4-week follow-up. Results: Of the 90 children (mean [SD] age, 9.51 [2.48] years; 49 [54.4%] male and 41 [45.6%] female) in the study, 78 (86.7%) completed the intervention, with 37 participants (mean [SD] age, 9.57 [2.38] years; 19 [51.4%] male) and 41 participants (mean [SD] age, 9.32 [2.37] years; 26 [63.4%] male) randomly assigned to the RAGT and control groups, respectively. Changes in the RAGT group significantly exceeded changes in the control group in GMFM-88 total (mean difference, 2.64; 95% CI, 0.50-4.78), GMFM-E (mean difference, 2.70; 95% CI, 0.08-5.33), GMFM-66 (mean difference, 1.31; 95% CI, 0.01-2.60), and PEDI-CAT responsibility domain scores (mean difference, 2.52; 95% CI, 0.42-4.63), indicating independence in daily living at postintervention assessment. At the 4-week follow-up, the RAGT group showed significantly greater improvements in balance control (mean difference, 1.48; 95% CI, 0.03-2.94) and Gait Deviation Index (mean difference, 6.48; 95% CI, 2.77-10.19) compared with the control group. Conclusions and Relevance: In this randomized clinical trial, overground RAGT using a wearable robot significantly improved gross motor function and gait pattern. This new torque-assisted wearable exoskeletal robot, based on assist-as-needed control, may complement standard rehabilitation by providing adequate assistance and therapeutic support to children with CP. Trial Registration: CRIS Identifier: KCT0006273.

A gamified virtual environment intervention for gait rehabilitation in Parkinson's Disease: co-creation and feasibility study.

BACKGROUND: Treadmill gait training has been shown to improve gait performance in People with Parkinson's Disease (PwPD), and in combination with Virtual Reality, it can be an effective tool for gait rehabilitation. The addition of gamification elements can create a more stimulating and adherent intervention. However, implementation of new technologies in healthcare can be challenging. This study aimed to develop and evaluate the feasibility of a treadmill rehabilitation program in a Gamified Virtual Reality Environment (GVRE) for PwPD. METHODS: The GVRE was developed following a user-centered design approach, involving both PwPD and physiotherapists in the development and evaluation of the intervention. The intervention consisted of a walking simulation in three different environments (countryside, city, and park), which had a progressive increase in difficulty. To test its feasibility, three sessions were carried out with four PwPD and four physiotherapists. To assess the usability, the System Usability Scale (SUS), Assistive Technology Usability Questionnaire for people with Neurological diseases (NATU Quest) and Simulator Sickness Questionnaire (SSQ) were used. To assess the intervention's acceptability, feedback and in-game performance was collected from participants. RESULTS: Results showed the feasibility of the intervention, with a SUS score of 74.82 ± 12.62, and a NATU Quest score of 4.49 ± 0.62, and positive acceptability feedback. Participants showed clear preferences for naturalistic environments, and gamification elements were seen as positive. Difficulty settings worked as intended, but lowered enjoyment of the experience in some cases. CONCLUSIONS: This intervention was successfully shown as a feasible option for the training of gait under Dual Task conditions for PwPD. It offers a safe and replicable environment in which complex situations can be trained. However, further iterations of the intervention need to be improved in order to guarantee accurate tracking and a more realistic training progression. TRIAL REGISTRATION NUMBER: NCT05243394-01/20/2022.

Effectiveness of Ultrasound Therapy, TheraBite Device, Masticatory Muscle Exercises, and Stabilization Splint for the Treatment of Masticatory Myofascial Pain: A Randomized Controlled Trial.

BACKGROUND: Myofascial pain syndrome (MPS) is a particular type of temporomandibular joint disorder. Research findings comparing various treatment approaches are scarce and controversial. Therefore, this study aimed to compare the effectiveness of ultrasound therapy, stabilization splint, TheraBite device, and masticatory muscle exercises in reducing pain intensity and improving mandibular mobility in patients with MPS. METHODS: It was a single-blind, randomized, parallel-group, active-controlled trial that took place between April 2023 and October 2023 at the Department of Fixed Prosthodontics, Damascus University. Patients older than 18 years old with myofascial pain accompanied by limited jaw opening and pain lasting for at least 6 months were included. Eighty patients were randomly assigned into four groups using online randomization software: ultrasound therapy, stabilization splint, TheraBite device, and masticatory muscle exercises. Only outcome assessors were masked to treatment allocation. The exercise regimen was the exercise program for patients with TMD. The following primary outcome measures were considered at the baseline (t0), at the first (t1), second (t2), and fourth (t3) week of treatment, and at the second (t4) and fifth (t5) month of follow-up: pain intensity using the visual analogue scale, maximum interincisal opening, right lateral movement, and left lateral movement measured in millimeters. RESULTS: The pain level changed from severe to mild at t3 in ultrasound therapy, stabilization splint, and TheraBite device groups. In the masticatory muscle exercises group, it changed to moderate, with a significant difference between ultrasound therapy (p = 0.012) and stabilization splint (p = 0.013) groups. In addition, the mandibular mobility continued to improve at the subsequent follow-up periods (t4 and t5). CONCLUSIONS: All therapies are equally effective after 5-month follow-up. However, ultrasound therapy and stabilization splints have the benefit of achieving rapid improvement. TRIAL REGISTRATION: ISRCTN20833186.

Automated, IMU-based spine angle estimation and IMU location identification for telerehabilitation.

BACKGROUND: Telerehabilitation is a promising avenue for improving patient outcomes and expanding accessibility. However, there is currently no spine-related assessment for telerehabilitation that covers multiple exercises. METHODS: We propose a wearable system with two inertial measurement units (IMUs) to identify IMU locations and estimate spine angles for ten commonly prescribed spinal degeneration rehabilitation exercises (supine chin tuck head lift rotation, dead bug unilateral isometric hold, pilates saw, catcow full spine, wall angel, quadruped neck flexion/extension, adductor open book, side plank hip dip, bird dog hip spinal flexion, and windmill single leg). Twelve healthy subjects performed these spine-related exercises, and wearable IMU data were collected for spine angle estimation and IMU location identification. RESULTS: Results demonstrated average mean absolute spinal angle estimation errors of 2.59 ∘ and average classification accuracy of 92.97%. The proposed system effectively identified IMU locations and assessed spine-related rehabilitation exercises while demonstrating robustness to individual differences and exercise variations. CONCLUSION: This inexpensive, convenient, and user-friendly approach to spine degeneration rehabilitation could potentially be implemented at home or provide remote assessment, offering a promising avenue to enhance patient outcomes and improve accessibility for spine-related rehabilitation. TRIAL REGISTRATION:  No. E2021013P in Shanghai Jiao Tong University.

Effects of training with a rehabilitation device (Rebless®) on upper limb function in patients with chronic stroke: A randomized controlled trial.

BACKGROUND: Upper limb dysfunction is one of the most common sequelae of stroke and robotic therapy is considered one of the promising methods for upper limb rehabilitation. OBJECTIVE: This study aimed to explore the clinical effectiveness of upper limb training using a rehabilitation robotic device (Rebless®) for patients with stroke. METHODS: In this prospective, unblinded, randomized controlled trial, patients were randomly assigned to receive robotic training (experimental group, n = 15) or conventional therapy (control group, n = 15). Both groups received upper limb training lasting for 30 minutes per session with a total of 10 training sessions within 4 weeks. Motor function, functional evaluation, and spasticity were clinically assessed before and after the training. Cortical activation was measured using functional near-infrared spectroscopy at the 1st and 10th training sessions. RESULTS: The experimental group demonstrated a significant improvement in the Fugl-Meyer assessment-upper extremity score and the modified Ashworth scale grade in elbow flexors. The cortical activity of the unaffected hemisphere significantly decreased after 10 training sessions in the experimental group compared with the control group. CONCLUSIONS: The experimental group showed significant improvement in the Fugl-Meyer assessment-upper extremity score and spasticity of elbow flexors and had significantly decreased cortical activity of the unaffected hemisphere. Training with Rebless® may help patients with chronic stroke in restoring upper limb function and recovering the contralateral predominance of activation in motor function.

Exoskeleton-based exercises for overground gait and balance rehabilitation in spinal cord injury: a systematic review of dose and dosage parameters.

BACKGROUND: Exoskeletons are increasingly applied during overground gait and balance rehabilitation following neurological impairment, although optimal parameters for specific indications are yet to be established. OBJECTIVE: This systematic review aimed to identify dose and dosage of exoskeleton-based therapy protocols for overground locomotor training in spinal cord injury/disease. METHODS: A systematic review was conducted in accordance with the Preferred Reporting Items Systematic Reviews and Meta-Analyses guidelines. A literature search was performed using the CINAHL Complete, Embase, Emcare Nursing, Medline ALL, and Web of Science databases. Studies in adults with subacute and/or chronic spinal cord injury/disease were included if they reported (1) dose (e.g., single session duration and total number of sessions) and dosage (e.g., frequency of sessions/week and total duration of intervention) parameters, and (2) at least one gait and/or balance outcome measure. RESULTS: Of 2,108 studies identified, after removing duplicates and filtering for inclusion, 19 were selected and dose, dosage and efficacy were abstracted. Data revealed a great heterogeneity in dose, dosage, and indications, with overall recommendation of 60-min sessions delivered 3 times a week, for 9 weeks in 27 sessions. Specific protocols were also identified for functional restoration (60-min, 3 times a week, for 8 weeks/24 sessions) and cardiorespiratory rehabilitation (60-min, 3 times a week, for 12 weeks/36 sessions). CONCLUSION: This review provides evidence-based best practice recommendations for overground exoskeleton training among individuals with spinal cord injury/disease based on individual therapeutic goals - functional restoration or cardiorespiratory rehabilitation. There is a need for structured exoskeleton clinical translation studies based on standardized methods and common therapeutic outcomes.

Effects of robot-assisted gait training using the Welwalk on gait independence for individuals with hemiparetic stroke: an assessor-blinded, multicenter randomized controlled trial.

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.

Effects of Rehabilitation Robot Training on Physical Function, Functional Recovery, and Daily Living Activities in Patients with Sub-Acute Stroke.

Stroke often results in sensory deficits, muscular weakness, and diminished postural control, thereby restricting mobility and functional capabilities. It is important to promote neuroplasticity by implementing task-oriented exercises that induce changes in patients. Therefore, this study aimed to investigate the effects of rehabilitation robot training on physical function, functional recovery, and activities of daily living (ADLs) in patients with subacute stroke. The study participants were patients with subacute stroke receiving treatment at Hospitals A and B. They were selected as research subjects based on selection and exclusion criteria. The experimental group received rehabilitation robot training in sessions of 30 min, five times weekly, for a total of 20 sessions over four weeks. Conversely, the control group underwent standard rehabilitation equipment training with an identical frequency, duration, and number of sessions. Measurements were taken before and after the training period to assess changes in physical function, functional recovery, and activities of daily living using tools such as the MMT, BBS, FBG, FAC, FIM, and MBI. The results were as follows: in the within-group comparison, the rehabilitation robot training group showed significant differences in MMT, BBS, FBG, FAC, FIM, and MBI (p < 0.05), while the control group showed significant differences in FIM (p < 0.05). Statistically significant differences were observed in the time, group, and time × group interaction effects among the MMT, static seated FBG, dynamic seated FBG, FIM, and MBI (p < 0.05). Based on these results, rehabilitation robotic training resulted in significant improvements in physical function, functional recovery, and activities of daily living in patients with subacute stroke. Based on these findings, providing a basic protocol for a rehabilitation program that applies rehabilitation robot training to patients with subacute stroke may offer more effective treatment and outcomes in the future.

Effects of integrated intrinsic foot muscle exercise with foot core training device on balance and body composition among community-dwelling adults aged 60 and above.

BACKGROUND: Evidence on the effects of plantar intrinsic foot muscle exercise in older adults remains limited. This study aimed to evaluate the effect of an integrated intrinsic foot muscle exercise program with a novel three-dimensional printing foot core training device on balance and body composition in community-dwelling adults aged 60 and above. METHODS: A total of 40 participants aged ≥ 60 years were enrolled in this quasi-experimental, single-group, pretest-posttest design; participants were categorized into two groups, those with balance impairment and those without balance impairment. The participants performed a 4-week integrated intrinsic foot muscle exercise program with a three-dimensional printing foot core training device. The short physical performance battery (SPPB) and timed up and go test were employed to evaluate mobility and balance. A foot pressure distribution analysis was conducted to assess static postural control. The appendicular skeletal muscle mass index and fat mass were measured by a segmental body composition monitor with bioelectrical impedance analysis. The Wilcoxon signed rank test was used to determine the difference before and after the exercise program. RESULTS: Among the 40 enrolled participants (median age, 78.0 years; female, 80.0%; balance-impaired group, 27.5%), the 95% confidence ellipse area of the center of pressure under the eyes-closed condition was significantly decreased (median pretest: 217.3, interquartile range: 238.4; median posttest: 131.7, interquartile range: 199.5; P = 0.001) after the exercise. Female participants without balance impairment demonstrated a significant increase in appendicular skeletal muscle mass index and a decrease in fat mass. Participants in the balance-impaired group exhibited a significant increase in SPPB. CONCLUSIONS: Integrated intrinsic foot muscle exercise with a three-dimensional printing foot core training device may improve balance and body composition in adults aged 60 and above. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05750888 (retrospectively registered 02/03/2023).

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.