井伊 卓真

Background/Objectives: Clinical trials have investigated the efficacy of rehabilitation robotics for various pathological conditions, but the overall impact on rehabilitation practice remains unclear. We comprehensively examined and analyzed systematic reviews (SRs) of randomized controlled trials (RCTs) investigating rehabilitative interventions with robotic devices. Methods: Four databases were searched using term combinations of keywords related to robotic devices, rehabilitation, and SRs. The SR meta-analyses were categorized into “convincing”, “highly suggestive”, “suggestive”, “weak”, or “non-significant” depending on evidence strength and validity. Results: Overall, 62 SRs of 341 RCTs involving 14,522 participants were identified. Stroke was most frequently reported (40 SRs), followed by spinal cord injury (eight SRs), multiple sclerosis (four SRs), cerebral palsy (four SRs), Parkinson’s disease (three SRs), and neurological disease (any disease causing limited upper- and lower-limb functioning; three SRs). Furthermore, 38, 21, and 3 SRs focused on lower-limb devices, upper-limb devices, and both upper- and lower-limb devices, respectively. Quantitative synthesis of robotic intervention effects was performed by 51 of 62 SRs. Robot-assisted training was effective for various outcome measures per disease. Meta-analyses offering suggestive evidence were limited to studies on stroke. Upper-limb devices were effective for motor control and activities of daily living, and lower-limb devices for walking independence in stroke. Conclusions: Robotic devices are useful for improving impairments and disabilities in several diseases. Further high-quality SRs including RCTs with large sample sizes and meta-analyses of these RCTs, particularly on non-stroke-related diseases, are required. Further research should also ascertain which type of robotic device is the most effective for improving each specific impairment or disability.

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.