Background: This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic chronic stroke patients.Methods: Study design was a multi-center, prospective, randomized, parallel-group study comparing three therapist-guided interventions (1-hour sessions, 3×/wk, 10 weeks). We identified 161 prospective patients with chronic, poststroke, upper-limb hemiplegia treated at participating rehabilitation centers. Patients were enrolled between November 29, 2016, and November 12, 2018 in Japan. A blinded web-based allocation system was used to randomly assign 129 qualifying patients into 3 groups: (1) conventional self-training plus conventional therapy (control, N=42); (2) robotic self-training (ReoGo-J) plus conventional therapy (robotic therapy [RT], N=44); or (3) robotic self-training plus constraint-induced movement therapy (N=43). Primary outcome: Fugl-Meyer Assessment for upper-extremity. Secondary outcomes: Motor Activity Log-14 amount of use and quality of movement; Fugl-Meyer Assessment shoulder/elbow/forearm, wrist, finger, and coordination scores; Action Research Arm Test Score; Motricity Index; Modified Ashworth Scale; shoulder, elbow, forearm, wrist, and finger range of motion; and Stroke Impact Scale (the assessors were blinded). Safety outcomes were adverse events.Results: Safety was assessed in 127 patients. An intention-to-treat full analysis set (N=121), and a per-protocol set (N=115) of patients who attended 80% of sessions were assessed. One severe adverse event was recorded, unrelated to the robotic device. No significant differences in Fugl-Meyer Assessment for upper-extremity scores were observed between groups (RT versus control: −1.04 [95% CI, −2.79 to 0.71],P=0.40; RT versus movement therapy: −0.33 [95% CI, −2.02 to 1.36],P=0.90). The RT in the per-protocol set improved significantly in the Fugl-Meyer Assessment for upper-extremity shoulder/elbow/forearm score (RT versus control: −1.46 [95% CI, −2.63 to −0.29];P=0.037).Conclusions: Robotic self-training did not improve upper-limb function versus usual self-training, but may be effective combined with conventional therapy in some populations (per-protocol set).Registration: URL:https://www.umin.ac.jp/ctr; Unique identifier: UMIN000022509.

Background: Robotic therapy has been demonstrated to be effective in treating upper extremity (UE) paresis in stroke survivors. However, it remains unclear whether the level of assistance provided by robotics in UE training could affect the improvement in UE function in stroke survivors. We aimed to exploratorily investigate the impact of robotic assistance level and modes of adjustment on functional improvement in a stroke-affected UE.Methods: We analyzed the data of 30 subacute stroke survivors with mild-to-severe UE hemiplegia who were randomly assigned to the robotic therapy (using ReoGo System) group in our previous randomized clinical trial. A cluster analysis based on the training results (the percentage of each stroke patient’s five assistance modes of robotics used during the training) was performed. The patients were divided into two groups: high and low robotic assistance groups. Additionally, the two groups were sub-categorized into the following classes based on the severity of UE functional impairment: moderate-to-mild [Fugl-Meyer Assessment (FMA) score ≥ 30] and severe-to-moderate class (FMA < 30). The outcomes were assessed using FMA, FMA-proximal, performance-time in the Wolf motor function test (WMFT), and functional assessment scale (FAS) in WMFT. The outcomes of each class in the two groups were analyzed. A two-way analysis of variance (ANOVA) was conducted with robot assistance level and severity of UE function as explanatory factors and the change in each outcome pre- and post-intervention as the objective factor.Results: Overall, significant differences of the group × severity interaction were found in most of the outcomes, including FMA-proximal (p = 0.038, η² = 0.13), WMFT-PT (p = 0.021, η² = 0.17), and WMFT-FAS (p = 0.045, η² = 0.14). However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η² = 0.09).Conclusion: An optimal amount of robotic assistance is a key to maximize improvement in post-stroke UE paralysis. Furthermore, severity of UE paralysis is an important consideration when deciding the amount of assistance in robotic therapy.Trial registrationTrial enrollment was done at UMIN (UMIN 000001619, registration date was January 1, 2009)

Background: Stroke patients experience chronic hemiparesis in their upper extremities leaving negative effects on quality of life. Robotic therapy is one method to recover arm function, but its research is still in its infancy. Research questions of this study is to investigate how to maximize the benefit of robotic therapy using ReoGo-J for arm hemiplegia in chronic stroke patients. Methods: Design of this study is a multi-center parallel group trial following the prospective, randomized, open-label, blinded endpoint (PROBE) study model. Participants and setting will be 120 chronic stroke patients (over 6 months post-stroke) will be randomly allocated to three different rehabilitation protocols. In this study, the control group will receive 20 min of standard rehabilitation (conventional occupational therapy) and 40 min of self-training (i.e., sanding, placing and stretching). The robotic therapy group will receive 20 min of standard rehabilitation and 40 min of robotic therapy using ReoGo^®-J device. The combined therapy group will receive 40 min of robotic therapy and 20 min of constraint-induced movement therapy (protocol to improve upper-limb use in ADL suggests). This study employs the Fugl-Meyer Assessment upper-limb score (primary outcome), other arm function measures and the Stroke Impact Scale score will be measured at baseline, 5 and 10 weeks of the treatment phase. In analysis of this study, we use the mixed effects model for repeated measures to compare changes in outcomes between groups at 5 and 10 Weeks. The registration number of this study is UMIN000022509. Conclusions: This study is a feasible, multi-site randomized controlled trial to examine our hypothesis that combined training protocol could maximize the benefit of robotic therapy and best effective therapeutic strategy for patients with upper-limb hemiparesis.

Purpose: To test whether diffusion tensor imaging could evaluate potential motor capability of patients with chronic cerebral infarction. Methods: We used constraint-induced movement therapy (CIMT) as a rehabilitation, which reveals potential motor capability. We also investigated the relationship between the outcome of CIMT and the ratio between fractional anisotropy values (rFA) in affected and unaffected sites of the corticospinal tract before CIMT. Imaging was performed in cerebral infarction patients (n = 14) and the rFA of the posterior limb of internal capsule (PLIC) was measured before CIMT. Patients were evaluated before and after CIMT using the Fugl-Meyer (F-M) assessment, Wolf Motor Function Test, Action Research Arm Test, and Motor Activity Log and association between PLIC- rFA and these scores was determined. Results: All patients showed an improvement in mobility following the 10-day CIMT session. Strong positive correlation was found only between F-M after CIMT and PLIC-rFA (r = 0.8098, p = 0.0004). A strong linear relationship was observed after CIMT. Conclusion: These data support PLIC-rFA as a new marker of the CIMT-induced improvement in motor function (F-M).

The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) has been used in many clinical studies and in stroke rehabilitation. In studies evaluating psychometric properties, confirmatory factor ana...

This review investigated the effectiveness of adjuvant therapy combined with constraint-induced movement therapy (CIMT) in improving the paretic upper limb functionality in adults with stroke sequelae during the subacute to chronic rehabilitation phase. In this systematic review and meta-analysis of randomized controlled trials (RCT), electronic databases, including PubMed, Web of Science, CINAHL, and MEDLINE, were searched. We included RCTs that investigated the outcomes of adjuvant therapy (i.e. other therapies) added to CIMT compared with CIMT alone. Key trial findings were qualitatively synthesized and analyzed. This meta-analysis examined variables, such as mean scores and standard deviations, using the following outcome measures: Fugl-Meyer Assessment (FMA) upper limb items, Action Research Arm Test (ARAT), Amount of Use (AOU) of Motor Activity Log (MAL), and Quality of Movement (QOM) of MAL. Eighteen eligible RCTs were included in the analysis. Adding CIMT to adjunctive therapy significantly improved FMA compared with CIMT alone (mean difference [MD] 4.02, 95% confidence interval [CI] 2.60-5.44; I² = 85%; 15 studies; 330 participants). Similarly, the ARAT and MAL-AOU scores improved significantly. CIMT combined with several adjunctive therapies effectively improved upper limb function.