平野 哲

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.

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).