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.

Factors affecting the efficiency of walking independence in patients with subacute stroke following robot-assisted gait training with conventional rehabilitation.

Factors affecting the efficiency of walking independence in patients with subacute stroke following robot-assisted gait training (RAGT) and conventional treatment (RAGT-CT) were examined. This retrospective cohort study included 37 patients with stroke [ n  = 11 ischemic; n  = 26 hemorrhagic; median poststroke interval, 28 days (interquartile range, IQR, 24-42)] who underwent RAGT using Welwalk for a median of 3 weeks (IQR, 2-4) followed by conventional training (median, 129 days; IQR, 114-146). The primary outcome was the change in functional independence measure (FIM)-walk item score from before to after RAGT (FIM-walk efficiency). The secondary outcome was the FIM-walk score at discharge. The independent variables included sensorimotor function [lower extremity (LE) motor and sensory scores and trunk function from the Stroke Impairment Assessment Set (SIAS) and Berg Balance Scale (BBS)] and cognitive function (FIM-cognitive, MMSE and Cognitive-related Behavioral Assessment) before RAGT-CT and RAGT dose duration per session, total steps and average treadmill speed at week 1, and number of sessions). We first determined the bivariate associations of each independent variable with the FIM-walk efficiency at the end of the RAGT period as decided by the therapists and with the FIM-walk score at discharge. Hierarchical multiple regression revealed that only the FIM-cognitive score was a significant predictor of the FIM-walk efficiency at the end of the RAGT period ( ß = 0.47; P  < 0.01, adjusted R2  = 0.21) after accounting for age, days post-stroke, SIAS-total lower extremity (SIAS-LE) motor score, and number of RAGT sessions (all nonsignificant). Furthermore, only the SIAS-trunk score was a significant predictor of the FIM-walk score at discharge ( ß = 0.52; P  < 0.01; adjusted R2  = 0.65) after accounting for age, days post-stroke, FIM-cognitive score, SIAS-LE motor score, and average treadmill speed at week 1 (all nonsignificant). Although patients with better cognition at the start of locomotor training achieved the pragmatic targets for terminating RAGT and proceeding with conventional therapy at a faster rate, the outcome at discharge is mainly dependent on early trunk function.

Effect of gait training using Welwalk on gait pattern in individuals with hemiparetic stroke: a cross-sectional study.

Introduction: We aimed to explore the effect of gait training using Welwalk on gait patterns by comparing differences in gait patterns between robotic-assisted gait training using Welwalk and gait training using an orthosis in individuals with hemiparetic stroke. Methods: This study included 23 individuals with hemiparetic stroke who underwent gait training with Welwalk combined with overground gait training using an orthosis. Three-dimensional motion analysis on a treadmill was performed under two conditions for each participant: during gait training with Welwalk and with the ankle-foot orthosis. The spatiotemporal parameters and gait patterns were compared between the two conditions. Results: The affected step length was significantly longer, the step width was significantly wider, and the affected single support phase ratio was significantly higher in the Welwalk condition than in the orthosis condition. The index values of abnormal gait patterns were significantly lower while using Welwalk than in the orthosis condition. The following four indices were lower in the Welwalk condition: contralateral vaulting, insufficient knee flexion, excessive hip external rotation during the paretic swing phase, and paretic forefoot contact. Discussion: Gait training using Welwalk increased the affected step length, step width, and single support phase while suppressing abnormal gait patterns as compared to gait training using the ankle-foot orthosis. This study suggests that gait training using Welwalk may promote a more efficient gait pattern reacquisition that suppresses abnormal gait patterns. Trial registration: Prospectively registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp; jRCTs042180152).

Acquisition Status of Basic Clinical Skills in Japanese Novice Rehabilitation Therapists: A Preliminary Single-Center Study.

The number of post-graduate rehabilitation therapists (novice therapists) is increasing due to the growing demand for rehabilitation services in Japan. This study investigated the acquisition status of Japanese novice therapists' basic clinical skills to clarify their quality and characteristics. Eleven participants' basic clinical skills (eight physical and three occupational therapists) were assessed using an Objective Structured Clinical Examination. Tasks included exercises of joint range of motion, muscle strengthening, getting up, standing up and sitting down, and transferring between wheelchair and bed. Assessment items were subdivided into categories: attitude, preparation, intervention, safety management, and feedback. One-way ANOVA and Friedman test were used for statistical analysis to compare the data between tasks and categories. The scores for each task's achievement rate were not statistically significant. However, the achievement rate of each category including tasks was 92.6% (SD 4.0%) for attitude, 81.4% (SD 11.1%) for preparation, 77.9% (SD 14.7%) for intervention, 87.6% (SD 17.3%) for safety management, and 64.0% (SD 14.2%) for feedback. There were significant differences between attitude and feedback (p < 0.001), and between safety management and feedback (p = 0.012). Post-graduate training programs should focus on improving the quality of clinical skills, especially in skills related to feedback.

Shock-absorbing effect of flooring-adopted mechanical metamaterial technology and its influence on the gait and balance of older adults.

OBJECTIVE: To elucidate the performance of a shock-absorbing floor material with a mechanical metamaterial (MM-flooring) structure and its effect on the gait and balance of older adults. METHODS: The drop-weight impact was applied to evaluate the shock-absorbing performance. The falling weight was adjusted equivalent to the energy exerted on the femur of an older woman when she falls, which was evaluated on the MM-flooring and six other flooring materials.Nineteen healthy people over the age of 65 years participated in the gait and balance evaluations. The timed up and go and two-step tests were adopted as gait performance tests, and the sway-during-quiet-balance test with force plates and the functional reach test (FRT) were adopted as balance tests. All the participants underwent these tests on the MM-flooring, shock-absorbing mat and rigid flooring. RESULTS: The shock-absorbing performance test revealed that MM-flooring has sufficient shock-absorbing performance, and suggesting that it may reduce the probability of fractures in the older people when they fall. The results of the gait performance test showed that the participants demonstrated the same gait performance on the MM-flooring and the rigid floor. In the quiet standing test, MM-flooring did not affect the balance function of the participants to the same extent as the rigid floor, compared with the shock-absorbing mat. In the FRT, no significant differences were found for any of the flooring conditions. CONCLUSIONS: MM-flooring has the potential to prevent fractures attributed to falls and does not affect the gait or balance of older adults.

Robot-assisted Gait Training Using Welwalk in Hemiparetic Stroke Patients: An Effectiveness Study with Matched Control.

OBJECTIVE: Although studies on the efficacy of the rehabilitation robot are increasing, there are few reports using the robot for gait training in the actual clinical setting. This study aimed to investigate the effectiveness of gait training using Welwalk in hemiparetic stroke patients in a real clinical setting. MATERIALS AND METHODS: This prospective study included 36 hemiparetic stroke patients who underwent gait training using Welwalk. We examined the walking ability improvement efficiency using Functional Independence Measure (FIM)-walk as the primary outcome, which was compared with that of 36 patients (matched control group) who underwent conventional rehabilitation. Other outcomes were the actual gait training period using Welwalk, raw FIM-walk score, lower extremity motor functions score in Stroke Impairment Assessment Set at discharge, and duration from stroke onset until discharge. RESULTS: The improvement efficiency of the FIM-walk was significantly higher in the Welwalk group than in the matched control group (control 0.48 ± 0.31, Welwalk 0.80 ± 0.38, p-value < 0.001). The mean gait training period using Welwalk was 5 weeks. No significant differences were found in other outcomes between the Welwalk group and the matched control group. CONCLUSION: This study demonstrated the effectiveness of gait training using Welwalk on the improvement efficiency of the FIM-walk in hemiparetic stroke patients in an actual clinical setting.

Persistent Effect of Gait Exercise Assist Robot Training on Gait Ability and Lower Limb Function of Patients With Subacute Stroke: A Matched Case-Control Study With Three-Dimensional Gait Analysis.

INTRODUCTION: Gait exercise assist robot (GEAR), a gait rehabilitation robot developed for poststroke gait disorder, has been shown to improve walking speed and to improve the poststroke gait pattern. However, the persistence of its beneficial effect has not been clarified. In this matched case-control study, we assessed the durability of the effectiveness of GEAR training in patients with subacute stroke on the basis of clinical evaluation and three-dimensional (3D) gait analysis. METHODS: Gait data of 10 patients who underwent GEAR intervention program and 10 patients matched for age, height, sex, affected side, type of stroke, and initial gait ability who underwent conventional therapy were extracted from database. The outcome measures were walk score of Functional Independence Measure (FIM-walk), Stroke Impairment Assessment Set total lower limb motor function score (SIAS-L/E), and 3D gait analysis data (spatiotemporal factors and abnormal gait patter indices) at three time points: baseline, at the end of intervention, and within 1 week before discharge. RESULTS: In the GEAR group, the FIM-walk score, SIAS-L/E score, cadence, and single stance time of paretic side at discharge were significantly higher than those at post-training (p < 0.05), whereas the stance time and double support time of the unaffected side, knee extensor thrust, insufficient knee flexion, and external rotated hip of the affected side were significantly lower (p < 005). However, no significant differences in these respects were observed in the control group between the corresponding evaluation time points. CONCLUSION: The results indicated significant improvement in the GEAR group after the training period, with respect to both clinical parameters and the gait pattern indices. This improvement was not evident in the control group after the training period. The results possibly support the effectiveness of GEAR training in conferring persistently efficient gait patterns in patients with poststroke gait disorder. Further studies should investigate the long-term effects of GEAR training in a larger sample.

Reliability and validity of a force-instrumented treadmill for evaluating balance: A preliminary study of feasibility in healthy young adults.

BACKGROUND: With the development of computer technology, computerized dynamic posturography provides objective assessments of balance and posture control under static and dynamic conditions. Although a force-instrumented treadmill-based balance assessment is feasible for balance evaluations, currently no data exists. OBJECTIVE: This study was undertaken to assess the reliability and validity of balance evaluations using a force-instrumented treadmill. METHODS: Ten healthy adults participated in evaluations using both the treadmill and the EquiTest. Four balance evaluations were conducted: Modified Clinical Test of Sensory Interaction on Balance, Unilateral Stance, Weight Bearing Squat, and Motor Control Test. RESULTS: All balance evaluations using the force-instrumented treadmill method shared good reliability (intraclass correlation coefficient ≥0.6). The Modified Clinical Test of Sensory Interaction on Balance, Unilateral Stance, and Weight Bearing Squat evaluations had a correlation of r < 0.5 with EquiTest, whereas the Motor Control Test balance evaluation had moderate correlations (r > 0.5) with the EquiTest. CONCLUSION: The results demonstrated that all balance evaluations using the force-instrumented treadmill were reliable, and that the Motor Control Test evaluation was moderately correlated with the EquiTest. Therefore, the use of a force-instrumented treadmill in balance evaluations might provide a certain level of value to clinical practice.