Robot-assisted Gait Training Research Articles

Response: Use of the WISCI-II score in assessing outcome of intensive robot-assisted gait training in spinal cord injury.

Response: Use of the WISCI-II score in assessing outcome of intensive robot-assisted gait training in spinal cord injury.

New protocol for early robot-assisted gait training after spinal surgery.

Early rehabilitation post-spinal surgery is vital for patients' recovery. Robot-assisted gait training (RAGT) shows promise but requires further study to establish a specific protocol and gauge its effects on both patients and physical therapists. This study aimed to determine the impact of a newly developed protocol for early RAGT on patients' functional enhancement and satisfaction levels after spinal surgery, as well as on the physical therapists who implemented the therapy. First, we developed the protocol in collaboration with three physiatrists and two physical therapists with extensive experience in musculoskeletal rehabilitation. The protocol was updated three times, each after three rounds of face-to-face meetings. Afterward, we conducted a cross-sectional study involving five physical therapists and 32 post-spinal surgery patients at a tertiary hospital rehabilitation center. The intervention consisted of five sessions of RAGT. Main outcome measures included the Functional Ambulation Category (FAC), the ambulation item of the Modified Barthel Index (MBI ambulation), and satisfaction surveys for both patients and physical therapists. RAGT typically started 17.91 ± 9.76 days postoperatively and was successfully applied with no remarkable adverse effects. The FAC scores increased from 2.65 ± 1.21 to 3.78 ± 0.71 (p = 0.006), and MBI ambulation increased from 7.69 ± 2.71 to 10.66 ± 2.90 (p < 0.001) between transfer and discharge. Satisfaction with the robot, RAGT, and treatment, assessed using a 5-point Likert scale, were 3.30 ± 0.79, 3.72 ± 0.85, and 3.08 ± 0.84, respectively. Satisfaction was notably the highest for alleviating fear of falling, whereas managing pain and discomfort during position changes scored the lowest. Physical therapists rated RAGT satisfaction, impact on the working environment, and treatment stability at 3.0 ± 0.65, 2.80 ± 0.67, and 3.50 ± 0.61, respectively. Early spinal surgery rehabilitation with RAGT improved patients' functionality and gait satisfaction. While physical therapists considered RAGT safe, its impact on their work environment was limited. Integrating RAGT into post-spinal surgery rehabilitation demands ongoing protocol refinement, custom robot development, and efficacy evaluations.

Effectiveness of robotic rehabilitation for gait and balance in people with multiple sclerosis: a systematic review.

This review investigated the effectiveness of robotic-assisted gait training (RAGT) in improving gait and balance performance in adults with multiple sclerosis (MS). Databases and registers were searched from inception to December 2023 to identify randomized controlled trials (RCTs) that analyzed the effects of RAGT on gait speed, function, balance, fatigue, and adverse events. Three reviewers screened studies for eligibility and extracted key information such as participants and intervention characteristics, as well as outcomes of interest. The reviewers assessed the risk of bias of included studies using Cochrane Risk of Bias tool. From the 948 records identified, 8 RCTs were included, involving 335 participants. The studies have demonstrated significant heterogeneity in patient characteristics, intervention protocols, and outcomes measured. The risk of bias assessment revealed concerns, mainly in terms of performance and detection bias. The evidence is uncertain on the effectiveness of RAGT on balance and gait in people with MS, but a multimodal rehabilitation approach, including RAGT, should be encouraged. No serious adverse events seem to be associated with RAGT, suggesting that these interventions are generally safe for use in people with MS. Further studies of higher methodological quality should be led to confirm these positive results.

Clinical Feasibility of Applying Immersive Virtual Reality during Robot-Assisted Gait Training for Individuals with Neurological Diseases: A Pilot Study.

Immersive virtual reality has the potential to motivate and challenge patients who need and want to relearn movements in the process of neurorehabilitation. The aim of this study was to evaluate the feasibility and user acceptance of an innovative immersive virtual reality system (head-mounted display) used in combination with robot-assisted gait training in subjects suffering from neurological diseases. Fifteen participants suffering from cerebrovascular accident or spinal cord injury completed a single session of immersive virtual reality using a head-mounted display during a Lokomat® gait session. Training parameters and safety indicators were collected, and acceptance was investigated among participants and therapists. The results suggest that an immersive virtual reality system is feasible in terms of safety and tolerance. Furthermore, the very positive overall acceptance of the system suggests that it has the potential to be included in a robot-assisted gait training session using Lokomat®. Overall, this study demonstrates that a fully immersive virtual reality system based on a head-mounted display is both feasible and well received by cerebrovascular accident and spinal cord injury patients and their therapists during robot-assisted gait training. This study suggests that such a virtual reality system could be a viable alternative to the screen-based training games currently used in neurorehabilitation. It may be especially suitable for enhancing patient motivation and adherence to training, particularly if the application is enjoyable and not mentally taxing.

Neuromotor recovery of walking in post-stroke individuals using TWIN-Acta-based robotic assisted gait training

Neuromotor recovery of walking in post-stroke individuals using TWIN-Acta-based robotic assisted gait training

Effect and optimal exercise prescription of robot-assisted gait training on lower extremity motor function in stroke patients: a network meta-analysis

Effect and optimal exercise prescription of robot-assisted gait training on lower extremity motor function in stroke patients: a network meta-analysis

Effects of high-intensity interval robot-assisted gait training on cardiopulmonary function and walking ability in chronic stroke survivors: A multicenter single-blind randomized controlled trial.

Chronic stroke can impair cardiopulmonary function, mobility, and daily activities. This study assessed the impact of robot-assisted gait training (RAGT) on such impairments. To investigate the effects of robot-assisted gait training on cardiopulmonary function, walking ability, lower extremity function and strength, activities of daily living (ADLs), and blood test results among individuals with chronic stroke. A multicenter, prospective, single-blinded, randomized controlled trial with 22 chronic stroke participants compared RAGT against a control exercise regimen. RAGT involved three days weekly sessions of high-intensity interval training for 8 weeks (24 sessions) with a Morning Walk® device. The control group also performed home exercises. (24 sessions) Measures included VO2max, Functional Ambulatory Category, 2-minute walk test, 10-meter walk test, Motricity Index-Lower, Korean version of the Fugl-Meyer Assessment Scale, Modified Barthel Index, Berg Balance Scale, muscle strength, InBody body composition, and blood tests (cholesterol, lipid, glucose). RAGT significantly improved VO2max, gait, balance, and lower limb strength compared with controls, with significant improvements in 2-minute walk test, 10-meter walk test, Motricity Index-Lower, and Fugl-Meyer Assessment outcomes. No changes were seen in muscle mass or blood markers. RAGT enhances cardiopulmonary function and ambulatory capacity in chronic stroke patients, underscoring its potential in stroke rehabilitation.

Robot-assisted gait training in patients with various neurological diseases: A mixed methods feasibility study.

Walking impairment represents a relevant symptom in patients with neurological diseases often compromising social participation. Currently, mixed methods studies on robot-assisted gait training (RAGT) in patients with rare neurological diseases are lacking. This study aimed to explore the feasibility, acceptability, goal attainment and preliminary effects of RAGT in patients with common and rare neurological diseases and understand the intervention context and process. A mixed-methods feasibility study was conducted at an Austrian rehabilitation centre. Twenty-eight inpatients after stroke in the subacute and chronic phases, with multiple sclerosis, Parkinson's disease, spinal cord injury, spinocerebellar ataxia, acute/chronic inflammatory demyelinating polyneuropathy and motor neuron disease were included. Patients received RAGT for 45 minutes, 4x/week, for 4 weeks. Baseline and post-intervention assessments included gait parameters, walking and balance, and questionnaires. Semi-structured observations were conducted twice during the intervention period and analysed using thematic analysis. Descriptive statistics within the respective disease groups and calculation of effect sizes for the total sample were performed. Triangulation was employed to develop a deeper understanding of the research topic. Data from 26 patients (mean age 61.6 years [standard deviation 13.2]) were analysed. RAGT was highly accepted by patients and feasible, indicated by recruitment, retention, and adherence rates of 84.8% (95% confidence interval, CI 0.7-0.9), 92.2% (95% CI 0.7-1.0) and 94.0% (95% CI 91.4-96.2), respectively. Goal attainment was high, and only mild adverse events occurred. Improvements in walking speed (10-Metre Walk Test, effect size r = 0.876), walking distance (6-Minute Walk Test, r = 0.877), functional mobility (Timed Up and Go, r = 0.875), gait distance (r = 0.829) and number of steps (r = 0.834) were observed. Four themes were identified: familiarising with RAGT; enjoyment and acceptance through a trusting therapeutic relationship; actively interacting; and minimising dissatisfaction. Sufficiently powered randomised controlled trials are needed to validate our results. German Clinical Trials Register, DRKS00027887.

Gait Performance and Brain Activity Are Improved by Gait Automatization during Robot-Assisted Gait Training in Patients with Burns: A Prospective, Randomized, Single-Blinded Study.

Background: Patients with lower extremity burn injuries have decreased gait function. Gait dysfunctions are compensated by activation of executive areas such as the prefrontal cortex (PFC). Although robot-assisted gait training (RAGT) can improve gait function, the training mechanisms of RAGT are unknown. We aimed to determine the clinical effects of RAGT in patients with burns and investigate their underlying mechanisms. Methods: This single-blind, randomized controlled trial involved 54 patients with lower extremity burns. The RAGT group underwent RAGT using SUBAR® and conventional training. The control (CON) group underwent only conventional training. The primary outcome was cortical activity measured using a functional near-infrared spectroscopy device before and after 8 weeks of training to confirm the compensatory effect of gait dysfunction. The secondary outcomes were the functional ambulation category (FAC) to evaluate gait performance, 6-min walking test (6 MWT) distance to measure gait speed, isometric force and range of motion (ROM) of lower extremities to evaluate physical function, and the visual analog scale (VAS) score to evaluate subjective pain during gait. Results: PFC activation during the gait phase in the RAGT group decreased significantly compared with that of the CON. The VAS score decreased and FAC score improved after 8 weeks of training in both groups. The 6 MWT scores, isometric strengths (the left knee flexor and bilateral ankle plantar flexors), and the ROMs (the extensions of bilateral hip and bilateral knee) of the RAGT group were significantly improved compared with those of the CON. RAGT improved gait speed, lower extremity ROMs, and lower extremity muscles strengths in patients with burns. Conclusions: The improvement in gait speed and cerebral blood flow evaluation results suggests that the automatization of gait is related to the treatment mechanism during RAGT.

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

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. To investigate the effectiveness of overground RAGT in children with CP using an untethered, torque-assisted, wearable exoskeletal robot. 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. 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. 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. 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. 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. CRIS Identifier: KCT0006273.

Surface electromyography vs clinical outcome measures after robot-assisted gait training in patients with spinal cord injury after post-acute phase of rehabilitation

Surface electromyography vs clinical outcome measures after robot-assisted gait training in patients with spinal cord injury after post-acute phase of rehabilitation

Evidence that robot-assisted gait training modulates neuroplasticity after stroke: An fMRI pilot study based on graph theory analysis

ObjectivesTo investigate alterations of whole-brain network after stroke and therapeutic mechanisms of robot-assisted gait training (RAGT). Methods21 stroke patients and 20 healthy subjects were enrolled, with the stroke patients randomized to either control group (n = 11) or robot group (n = 10), and resting-state functional magnetic resonance imaging data were collected. The global network metrics were obtained using graph theory analysis and compared between stroke patients and healthy subjects, and the effect of the RAGT on the whole-brain networks was explored. ResultsCompared to healthy subjects, area under the curve (AUC) for small-worldness (σ), clustering coefficient (Cp), global efficiency (Eg) and mean local efficiency (Eloc) were significantly lower in stroke patients, whereas AUC for characteristic path length (Lp) were significantly higher. Compared with the control group, patients in robot group showed significant improvement in lower limb motor function, balance function and walking function after intervention, with a significant reduction in the AUC of Cp. Moreover, the improvement of walking function was positively correlated with the changes of AUC of σ and Eg, and negatively correlated with the changes of AUC of Cp. ConclusionsSmall-worldness and network efficiency were significantly reduced after stroke, whereas RAGT decreased characteristic path length and promoted normalization of the whole-brain network, and this change was associated with improvement in walking function. Our findings reveal the mechanism by which RAGT regulates network reorganization and neuroplasticity after stroke.

Current Trends in Effectiveness of Robotic Assisted Gait Training (RAGT) for Gait Recovery in Neuro Rehabilitation - An Evidence-Based Scoping Review

Robotic-assisted gait training plays a pivotal role in the rehabilitation of individuals recovering from post-stroke and post-spinal cord injuries. By employing sophisticated robotics, this therapy facilitates repetitive, task-specific movements essential for relearning walking patterns. The precision and customisation of robotic systems ensure tailored interventions targeting specific impairments. Moreover, these technologies provide real-time feedback, enhancing patient engagement and motivation. In this review, 11 articles were finalized for review, five were for post-stroke rehabilitation and 6 for spinal cord injuries. Results show that there is improvement in Spatiotemporal parameters of gait, functional outcomes and quality of life. In Conclusion, robotic-assisted gait training ultimately accelerates recovery, improves functional outcomes, and restores independence, profoundly impacting rehabilitation effectiveness. KEYWORDS: Assistive technology, Robotics, Gait parameters, Neurorehabilitation, Functional outcome.

The Impact of Botulinum Toxin Combined with Robot-Assisted Gait Training on Spasticity and Gross Motor Function on Children with Spastic Cerebral Palsy

ABSTRACT Objective To evaluate the impact of combining botulinum toxin-A (BoNT-A) injection with robot-assisted gait training (RAGT) on lower limb spasticity and motor function in children with cerebral palsy. Methods A prospective study was conducted from January 2020 to January 2023, including 68 patients. Twenty patients received the combination of BoNT-A injection and RAGT, while 48 received BoNT-A injection alone. Assessments were performed before the intervention and at 1, 3, and 6 months post-injection using the Modified Tardieu Scale (MTS), sections D and E of the Gross Motor Function Measure-88 (GMFM-88), 6-minute walk test (6MWT), and 10-meter walk test (10MWT). Results Compared to the control group receiving BoNT-A alone, the combination of BoNT-A and RAGT did not significantly improve spasticity-related outcomes, including MTS scores, R1, and R2 angles (p > .05). However, the combination group demonstrated significantly improved gross motor function, particularly in walking, running (GMFM-E), short-term walking endurance (6MWT), and walking speed (10MWT) in children with cerebral palsy after the intervention (p < .05). Conclusion While the addition of RAGT did not enhance the anti-spasticity effects of BoNT-A, it significantly improved gross motor function and walking abilities in children with cerebral palsy.

Robot-Assisted Gait Training in Individuals With Spinal Cord Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Spinal cord injury (SCI) rehabilitation emphasizes locomotion. Robotic-assisted gait training (RAGT) is widely used in clinical settings because of its benefits; however, its efficacy remains controversial. We conducted a systematic review and meta-analysis to investigate the efficacy of RAGT in patients with SCI. We searched international and domestic databases for articles published until April 18, 2024. The meta-analysis employed a random effects model to determine the effect size as either mean difference (MD) or standardized MD (SMD). Evidence quality was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Twenty-three studies with a total of 690 participants were included in the final analysis. The overall pooled effect size for improvement in activities of daily living was 0.24, with SMD (95% confidence interval [95% CI], 0.04-0.43; GRADE: high) favoring RAGT over conventional rehabilitation. Muscular strength (MD, 0.23; 95% CI, 0.02-0.44; GRADE: high), walking index for SCI (MD, 0.31; 95% CI, 0.07-0.55; GRADE: moderate) and 6 min walk test distance (MD, 0.38; 95% CI, 0.14-0.63; GRADE: moderate) showed significant improvement in the robot group. Subgroup analysis revealed that subacute patients and intervention periods >2 months were more effective. This meta-analysis revealed that RAGT significantly improved activities of daily living, muscular strength, and walking abilities. Additional studies are needed to identify the optimal treatment protocol and specific patient groups for which the protocol is most effective.

The Cognitive Reserve May Influence Fatigue after Rehabilitation in Progressive Multiple Sclerosis: A Secondary Analysis of the RAGTIME Trial

Cognitive reserve (CR) seems to be an ability to adapt cognitive processes in response to brain disease and may influence rehabilitation outcomes. This is a secondary analysis of the “Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressive MultiplE sclerosis patients” (RAGTIME) trial to investigate the influence of CR on the outcomes after gait rehabilitation in people with multiple sclerosis (PwMS). We included 53 PwMS and severe gait disability (EDSS 6–7). The participants were randomized into two groups to receive either robot-assisted gait training or overground walking (three times/week over four weeks). CR was evaluated by the Cognitive Reserve Index questionnaire (CRIq), which encompasses three sections (CRI Education, CRI Working Activity, and CRI Leisure Time). We stratified the patients using the 115 cut-off CRIq total score of at least a medium-high CR. The outcome measures were Timed 25-Foot Walk, 6 min walking test, Berg Balance Scale, Multiple Sclerosis Impact Scale—29, Multiple Sclerosis Walking Scale—12, Patient Health Questionnaire—9, and Fatigue Severity Scale (FSS). After gait rehabilitation, the FSS was significantly improved in those patients with higher CR compared with the others (F = 4.757, p = 0.015). In our study, CR did not affect the gait, balance, disability perception, and depression. Conversely, it positively influenced the fatigue after gait rehabilitation.

Traditional versus progressive robot-assisted gait training in people with multiple sclerosis and severe gait disability: study protocol for the PROGR-EX randomised controlled trial

Gait disorders are the most frequent symptoms associated to multiple sclerosis (MS). Robot-assisted gait training (RAGT) in people with MS (PwMS) has been proposed as a possible effective treatment option...

Robot-assisted gait training improves walking and cerebral connectivity in children with unilateral cerebral palsy.

Robot-assisted gait training (RAGT) is promising to help walking rehabilitation in cerebral palsy, but training-induced neuroplastic effects have little been investigated. Forty unilateral cerebral palsy children aged 4-18 years were randomly allocated in a monocentric study to ten 20-minute RAGT sessions with the G-EO system, five days a week (n = 20) or to a control group (who continued conventional care with six 30-minute physiotherapy sessions, three days a week) (n = 20), two weeks running, from September 2020 to December 2021. Clinical and MRI outcomes were compared before and one month after therapy. The primary outcome was gait speed. Secondary outcomes were a 6-minute walking test distance, Gross Motor Function Measure-88 (GMFM-88) dimensions D and E, Patient Global Impression of Improvement, resting-state functional connectivity within the sensorimotor network, and structural connectivity in the corticospinal tracts. Gait speed and the 6-minute walking test distance improved more after RAGT. Resting-state functional connectivity increased after RAGT but decreased in controls between superior and lateral healthy or lateral injured sensorimotor networks. GMFM-88 and structural connectivity in corticospinal tracts were unchanged. Impression of improvement in children was better after RAGT. Short-term benefit of repetitive RAGT on walking abilities and functional cerebral connectivity was found in unilateral cerebral palsy children. Short-term repetitive robot-assisted gait training improves gait speed and walking resistance and increases cerebral functional connectivity in unilateral cerebral palsy. GMFM dimensions D and E were unchanged after short-term repetitive robot-assisted gait training in unilateral cerebral palsy.

Virtual Reality Applications for Balance Rehabilitation and Efficacy in Addressing Other Symptoms in Multiple Sclerosis—A Review

(1) Background: Since multiple sclerosis (MS) is a neurological pathology known for its disabling effects across many domains, the introduction of virtual reality (VR) usage has been attempted, as it represents a new method of approach to rehabilitation and treatment of chronic neurological pathologies. Encouraging research has explored the use of video game consoles and VR-assisted Robot-Assisted Gait Training (RAGT) to address balance disturbances in this population. (2) Methods: The search involved two databases, Web of Science and PubMed, utilizing a selection of terms including “Virtual reality”, “Multiple sclerosis”, “Balance”, and “Rehabilitation”. Two reviewers initiated and performed the search for articles, subsequently selecting and extracting data from the studies. The PEDro scale was the tool for evaluating the quality of the articles that we introduced in our research. (3) Results: After rigorous scanning, nine articles remained eligible for our study. VR interventions, particularly compared to standard balance training, consistently improved balance in multiple sclerosis. Robotic-assisted technology with 2D VR yielded superior results in balance rehabilitation. VR interventions had varied effects on walking speed. They have shown promise in decreasing the risk of falls and improving patients’ daily lives while reducing fatigue in multiple sclerosis. (4) Conclusions: VR offers comparable or superior benefits to classical exercise and no intervention for balance but does not significantly improve functional mobility. However, it shows the potential to improve quality of life and fatigue in MS patients. Investigation of VR alongside RAGT is important to be performed with larger sample sizes and comprehensive results are needed to fully understand its efficacy in MS rehabilitation.

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

BackgroundGait 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.MethodsAn 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.ResultsA 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).ConclusionsThe 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 registrationThis study was registered with the Japan Registry of Clinical Trials (https://jrct.niph.go.jp; jRCT 042180078) on March 3, 2019.