井伊 卓真

BACKGROUND: Robot-assisted gait training (RAGT) has proven effective in addressing gait disorders in patients with stroke. However, its efficacy in patients with acute stroke has not yet been demonstrated. This pilot study is designed to evaluate the following: (1) feasibility of conducting a randomized controlled trial on RAGT for enhancing gait postacute stroke and (2) to obtain preliminary estimates regarding the potential efficacy of RAGT for achieving gait independence during the acute phase. METHODS: We will conduct an assessor-blinded, single-center, randomized controlled pilot trial involving 32 patients with acute stroke who are unable to walk. Participants will be randomly assigned to either the RAGT or the conventional gait training (CGT) groups. Each participant will receive 180 min of daily rehabilitation, including 60 min dedicated to gait training. The RAGT group will receive 40 min of RAGT and 20 min of CGT, while the CGT group will engage in 60 min of CGT. Interventions will continue for up to 8 weeks, or until participants achieve gait independence, as indicated by a Functional Ambulation Category score of ≥ 3. Feasibility outcomes will include recruitment, enrollment, protocol adherence, and retention rates. The primary clinical outcome will be the incidence of achieving gait independence during the intervention period. Secondary clinical outcomes will include gait performance measures, assessments of physical function and activity, and intervention dose. Adverse events associated with RAGT and CGT will also be documented to evaluate the safety of both interventions. DISCUSSION: Implementing RAGT during the acute phase of stroke may facilitate earlier attainment of gait independence compared to CGT. We aim to provide valuable insights into the feasibility of the proposed study design and generate preliminary data on the potential effects of RAGT on gait independence in the acute phase of stroke, providing a framework for future larger-scale trials. TRIAL REGISTRATION: This clinical trial was registered with the Japan Clinical Trials Registry (jRCT) on 19 June 2023 (registration number: jRCTs042230040). The study protocol was initially registered as version 1.0 and has since undergone minor amendments-currently on version 4.0. This protocol was written based on the latest version (ver. 4.0) registered with jRCT.

OBJECTIVES: With the recent progression of a super-aging society in Japan, demand for medical and welfare professionals has increased, and occupational therapists are in great demand. Academic performance is important for occupational therapy and rehabilitation students. The current study aimed to determine the influence of self-esteem and psychological factors on academic performance in Japanese occupational therapy students. METHODS: A cross-sectional study was conducted among 60 first-year occupational therapy students (16 male and 44 female) at a private medical university in Japan in June 2022. The State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory Second Edition (BDI-II) were used to assess anxiety and depression symptoms, respectively, and the Rosenberg Self-Esteem Scale (RSES) was used to assess self-esteem. RESULTS: We identified several factors affecting the examination performance of Japanese occupational therapy students. Self-esteem was significantly associated with examination performance in anatomy 1 (p=0.02, β=0.40). RSES-J social work (p=0.07, β=0.31) and anatomy 2 (p=0.08, β=0.30), STAI-JYZ (p=0.09, β=0.38), and STAI-JYZ rehabilitation medicine (p=0.06, β=0.44), and BDI-II (p=0.08, β=-0.43) showed no significant effects but exhibited a trend toward an association. CONCLUSIONS: Understanding the role of psychological aspects and self-esteem is important for constructing systems to support first-year university students. Furthermore, the development of psychological aspects and self-esteem is essential for improving the academic performance of occupational therapy students, and it is crucial to establish educational programs and support systems.

BACKGROUND: Robot-assisted gait training (RAGT) is an effective method for treating gait disorders in individuals with stroke. However, no previous studies have demonstrated the effectiveness of RAGT in individuals with acute stroke. This study aimed to investigate the effects of RAGT initiation within 1 week after onset on degree of gait independence in individuals with hemiparetic stroke. METHODS: This retrospective cohort study used propensity-score matching. Individuals admitted to Fujita Health University Hospital after stroke onset and underwent RAGT between March 2017 and June 2023 were enrolled. Ninety-two individuals were eligible and grouped into the acute (≤ 7 days after the onset) and subacute groups (8-90 days after onset). RAGT was conducted using Welwalk, primarily comprising a knee-ankle-foot orthosis type robot worn on one paralyzed lower extremity, with training sessions lasting approximately 40 min/day, occurring 3-7 days/week. The primary outcome was the gait under supervision within 90 days of onset, which was compared between groups using the log-rank test. RESULTS: After propensity-score matching, 36 individuals were included in the analysis, including 18 each in the acute and subacute groups; the participant demographics were not significantly different between the groups. RAGT was initiated at a median of 6 and 25 days after onset in the acute and subacute groups, respectively. The Kaplan-Meier curves after the log-rank test showed a significantly higher percentage and shorter median days to achieve gait under supervision in the acute group than in the subacute group. The cumulative incidence of gait under supervision events at 90 days after onset was 82.2% and 55.6% in the acute and the subacute groups, respectively. Half of the individuals achieved gait under supervision within 49 days and 75 days in the acute and subacute groups, respectively (p = 0.038). No significant differences were observed in the dose of rehabilitation program and gait training per day from onset to achieving gait under supervision. CONCLUSION: Initiation of RAGT within 1 week after stroke onset in individuals with hemiparesis may reduce the number of days required to achieve gait under supervision and increase the percentage of gait under supervision.

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.

脳卒中後の片麻痺者における歩行障害はリハビリテーション治療の重要なテーマである．これまでに歩行練習の方法が多く提案され，効果が検証されているが，身体機能や歩行能力，発症後の時期に応じて練習目的や適応は異なり，対象に応じた内容の選定が必要である．本稿では，脳卒中治療ガイドラインで推奨されている下肢装具やトレッドミル，機能的電気刺激を用いた歩行練習の有用性について紹介する．また，近年注目されているロボットを用いた歩行練習についても臨床効果や作用機序を解説し，活用方法についても紹介する．

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).

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.

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.

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.