Gait training with a wearable curara ® robot during stroke rehabilitation: a randomized parallel-group trial

Abstract Background: Recently, robot-assisted gait training (RAGT) has been applied widely to individuals with stroke to regain and improve walking ability. We have developed a non-exoskeleton rehabilitation robot, “curara®,” and examined its immediate effect in patients with spinocerebellar degeneration and stroke, but its rehabilitative effect has not been clarified. The purpose of this study was to examine the effect of curara® on gait training in stroke patients.Methods: Forty stroke patients were enrolled in this study. The participants were divided randomly into two groups (groups A and B). The subjects in group A were assigned RAGT with curara® type 4, whereas those in group B received conventional therapist-assisted gait training. The clinical trial period was 15 days. The 10-m walking time (10mWT), 6-min walking distance (6mWD), timed up and go test, and gait parameters (stride duration and length, standard deviation of stride duration and length, cadence, ratio of the stance/swing phases, minimum/maximum knee joint angle, and minimum/maximum hip joint angle) were measured using a RehaGait® analyzer. The Berg Balance Scale was evaluated on days 0 and 14. Gait training was performed for 30 ± 5 min per day through days 2–6 and days 8–13 (total, 12 days) in both groups. The improvement rate was calculated as the difference of values between days 14 and 0 divided by the value on day 0. The improvement rates of the 10mWT and 6mWD were set as the main outcomes.Results: The data of 35 participants were analyzed. There was no significant difference in the main outcomes between both groups. As for intragroup changes, gait speed, stride length, stride duration, and cadence were improved significantly between days 0 and 14 in each group. There was no significant difference between the measured joint angle and the left-right angle ratio of symmetry within or between the groups. When assessing the interaction effect between the day of measurement and group, stride duration and cadence were more significantly improved in group A than in group B.Conclusions: The wearable curara® robot has the potential to improve gait function during stroke rehabilitation.Trial registration: Japan Registry of Clinical Trials (jRCTs032180163). Registered on February 22, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs032180163UMIN Clinical Trials Registry (UMIN000034237). Registered on September 22, 2018; https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000038939