So no real difference.
Gait training with a wearable powered robot during stroke rehabilitation: a randomized parallel-group trial
Journal of NeuroEngineering and Rehabilitation volume 20, Article number: 54 (2023)
Abstract
Background
We have developed a wearable 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 this device 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 participants assigned to group A received RAGT with curara® type 4, whereas those in group B received conventional therapist-assisted gait training. The clinical trial period was 15 days. The participants performed 10 sessions of gait training (5 times per week) each lasting 30 ± 5 min per day. The 10-m walking time (10mWT), and 6-minute walking distance (6MWD) were evaluated as the main outcomes. Timed up and go and Berg Balance Scale (BBS) were also examined. 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®. The items other than BBS were measured on days 0, 7, and 14, whereas BBS was measured on days 0 and 14. 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 at the end of gait training. As for intragroup changes, gait speed, stride length, stride duration, and cadence were improved significantly between days 0 and 14 in each group. When examining the interaction effect between the day of measurement and group, stride duration (p = 0.006) and cadence (p = 0.012) were more significantly improved in group A than in group B.
Conclusions
This novel wearable powered robot may have the potential to improve gait speed of individuals in stroke rehabilitation.
Trial registration
Japan Registry of Clinical Trials (jRCTs032180163). Registered on February 22, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs032180163.
UMIN Clinical Trials Registry (UMIN000034237)
Registered on September 22, 2018; https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000038939.
Background
Recently, robot-assisted gait training (RAGT) has been applied widely to individuals with stroke to regain and improve walking ability [1]. In the 1990s, body weight-supported treadmill training was introduced in the clinical setting [2]. Currently, rehabilitation robots with different assistive forms for lower limb movements have become popular, e.g., Gait Trainer® and Haptic Walker®, which assist with foot movements, and Lokomat®, which assists with lower limb orthosis on a treadmill. These devices enable the joints of the lower limbs to move in a state close to normal during walking without voluntary efforts from the patient [3,4,5].
In addition to stationary rehabilitation robots, wearable rehabilitation robots have been developed recently and used widely in gait training, e.g., Hybrid Assistive Limb (HAL®) and ReWALK® [6]. Generally, wearable rehabilitation robots are smaller and lighter than stationary rehabilitation robots; therefore, a great advantage of these devices is that individuals wearing them can move around freely. This makes it possible for people with a wearable rehabilitation robot to perform overground training in daily life. Systematic reviews have reported that rehabilitation robots improve balance and ankle spasticity in patients with brain diseases including stroke [7, 8]. Concerning the rehabilitative effect of HAL®, the degree of walking independence evaluated by the Functional Ambulation Category was significantly improved in the HAL®-wearing group compared to the non-wearing group [9, 10]. In addition, there are reports that RAGT showed more significant improvement in the time up and go (TUG) test, 10mWT and 6MWD than conventional walking training [11, 12].
We started clinical research in 2017 for the practical application of a wearable rehabilitation robot, “curara®”. We have examined the effect of the device in patients with spinocerebellar degeneration [13, 14] and stroke [15]. We have shown that the use of the device improves walking speed, stride length, walking rate, and asymmetry in stroke patients temporarily [15], but we have not yet clarified its rehabilitative effect on gait training. Therefore, the purpose of this study was to examine the effect of the device on gait training in stroke patients.
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