Discussion
®, stroke, knee joints, hemiparesis
ADVERSE EVENTS, STROKE
Seventeen out of 20 participants tolerated and coped well with a 15-day clinical trial with the device without any adverse events. The primary outcome measures in this study showed significant improvements (10–20% of the baseline value) in both groups; however, contrary to our expectations, there were no significant differences between the groups. The same outcome was found for the BBS and TUG.When analyzing the RehaGait® data, significant intragroup differences in several parameters between days 0 and 14 were found in both groups. In particular, stride duration and cadence showed a more significant improvement in group A compared to the group B (interaction effect: In this study, all the participants were rather mild in the severity of hemiparesis at baseline because they had to train with the device (~ 5 kg) burdened when they were randomized to group A. In fact, the averaged gait speed was 0.90 m/sec at baseline (Another concern was whether or not the assistance provided by the device was best for each participant. We did not set synchronization gain at the hip and knee joints according to individual gait performance. Synchronization gain may be related to error learning that involves the trial and error required for motor learning [During the study, we felt that the affinity of the participants to the robot varied from individual to individual. Roughly speaking, the more elderly individuals tended to have less affinity for the device than the younger ones, and individuals with better walking ability had lower motivation to practice with the robot. One factor influencing affinity to the robot was that RAGT is still being developed as a method for stroke rehabilitation throughout Japan. For RAGT to become more popular, high-quality evidence should be acquired in future randomized case-control studies.At least, we can say that RAGT with curara® had a rehabilitative effect identical to that of therapist-assisted gait training. Our initial motive was to develop a wearable robot that elderly or handicapped people can use for gait rehabilitation in daily life. The results shown above are encouraging for us to improve the devise further. First, we need to improve its operability and user friendliness so that anybody can use it easily. At the present time, we are creating an advanced type of robot using the experience and knowledge acquired in this study. Furthermore, we need to identify the best application timing and assist conditions for the device in stroke patients.