With no significant difference in the main outcomes I don't see the validity of the conclusion that the potential exists to improve gait function. The mentors and senior researchers didn't catch that discrepancy?
Gait training with a wearable curara ® robot duringstroke rehabilitation: a randomized parallel-group trial
Daichi Miyagawa
JA Nagano Koseiren Kakeyu-Misayama Rehabilitation Center Kakeyu Hospital
Akira Matsushima
JA Nagano Koseiren Kakeyu-Misayama Rehabilitation Center Kakeyu Hospital
Yoichi Maruyama
JA Nagano Koseiren Kakeyu-Misayama Rehabilitation Center Kakeyu Hospital
Noriaki Mizukami
International Professional University of Technology in Tokyo
Mikio Tetsuya
AssistMotion Inc
Minoru Hashimoto
Shinshu University
Kunihiro Yoshida ( kyoshida@shinshu-u.ac.jp )
Shinshu University School of Medicine
Posted Date: May 3rd, 2022
DOI: https://doi.org/10.21203/rs.3.rs-1592253/v1
License:
This work is licensed under a Creative Commons Attribution 4.0 International License.
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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/jRCTs032180163
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