加藤 大典

Background Radial extracorporeal shock wave therapy (rESWT) improves lower-limb spasticity after stroke. However, the efficacy of rESWT in individuals with hemiparetic stroke in the subacute phase, in whom neural components of spasticity are thought to predominate, has not been sufficiently investigated. In addition, the effects of different numbers of stimulations on the magnitude and duration of spasticity improvement remain unclear. Objective We aim to explore the effects of different numbers of stimulations during a single rESWT session on lower-limb spasticity in individuals with subacute stroke and assess the feasibility and safety of the evaluation and treatment procedures for future large-scale trials. Methods This single-center, open-label pilot randomized controlled trial will enroll 24 individuals with subacute stroke and spasticity who will be randomly assigned to either the rESWT 3000- or 6000-stimulation group for 1 treatment at the triceps surae muscle, with stimulation applied at 3 locations: the medial and lateral heads of the gastrocnemius muscle and the triceps surae muscle–Achilles tendon junction. The stimulation intensity will be the maximum intensity tolerated by the individual (≤3.0 bar), with a 10-Hz fixed frequency. Evaluations will be performed the day before treatment; immediately before and after completion of treatment; at 1 and 8 hours after treatment; and at 1, 2, 3, 5, 7, and 14 days after treatment. The primary clinical outcome is the intergroup difference in the Modified Ashworth Scale score of the triceps surae immediately after completion of treatment. Secondary clinical outcomes include intergroup differences in Modified Ashworth Scale scores at 1 and 8 hours and on days 1, 2, 3, 5, 7, and 14 after treatment, as well as intragroup differences from baseline to each evaluation point. Additional measures include the range of motion, angle of catch, tendon reflexes, and clonus scores. Feasibility will be assessed using the recruitment, enrollment, adherence, and retention rates. Safety will be assessed by recording the occurrence of serious and treatment-related adverse events. Results This study was approved by the Fujita Health University Institutional Review Board on September 26, 2024 (CR24-033). Participant enrollment commenced on November 19, 2024. By November 25, 2025, a total of 14 participants had been enrolled. Data analysis has not commenced, and the results will be reported in a separate article in 2026. Conclusions This exploratory dose comparison pilot study is designed to explore whether the number of stimulations delivered during a single rESWT session influences the extent of short-term improvement in spasticity following subacute hemiparetic stroke and obtain preliminary clinical outcomes and feasibility and safety data for future large-scale trials. Trial Registration Japan Registry of Clinical Trials jRCTs042240098; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs042240098 International Registered Report Identifier (IRRID) DERR1-10.2196/88443

ABSTRACT Radial extracorporeal shock wave therapy showed immediate spasticity reduction and sustained range of motion improvement in a patient with subacute stroke. However, twice‐weekly sessions were insufficient for lasting spasticity control, suggesting that more frequent treatments may be required. Further research is needed to optimize treatment protocols.

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.

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: The Gait Exercise Assist Robot (GEAR) has been developed to support gait training for stroke patients. The GEAR can assist paretic lower limb swing and stance stability, which make it possible to practice walking without excessive compensation movements. However, there are no studies to-date that investigate the effect of the GEAR on gait pattern.Objectives: The purpose of this study was to clarify the effect of gait training on gait pattern using the GEAR for rehabilitation in stroke patients.Methods: Fifteen hemiplegic patients who received gait training using the GEAR were recruited (GEAR group). As a control group, hemiplegic patients who did not receive gait training using the GEAR were selected for each patient in the GEAR group from 114 cases in our hospital database. Primary outcomes were index values indicating the degree of 10 abnormal gait patterns. Secondary outcomes were spatiotemporal factors and comfortable overground gait velocity.Results: Index values for abnormal gait patterns were significantly lower in the GEAR group compared to the control group for insufficient knee flexion during the swing phase, hip hiking, and excessive lateral shift of the trunk over the unaffected-side (p < .05). The comfortable overground gait velocity, stride length, and unaffected-step length in the GEAR group were significantly better than in the control group (p < .05).Conclusions: Gait training using the GEAR had effects on reducing abnormal gait patterns and improving gait velocity, stride, and unaffected-side step length compared to conventional gait training alone in individuals recovering from stroke-induced hemiplegia.