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The effects of using a walking assistant robot "RE-Gait"

The effects of a walking assistant robot "RE-Gait"

46

Forty-six hemiplegic patients, 30 men and 16 women (ages 51-78), who were at least one month post-stroke and considered at relatively low risk for recurrent stroke. Subjects were randomly divided into two groups: RE-Gait group (27 patients) and control group (19 patients).

The pace of enrollment was delayed due to the COVID-19. By the time the study was discontinued, consent was obtained from a total of 49 subjects at four sites, and data were obtained from a total of 46 cases.

No occurrence of disease

Gait measurements were performed as the primary endpoint. In the RE-Gait group, the averaged gait speed changed from 0.702 to 0.753m/s (p<0.01, ES=0.14) and step length changed from 0.434 to 0.450m (p=0.04, ES=0.11), showing a trend of improvement in gait speed and step length. On the other hand, in the control group, they did not change from 0.729 to 0.719m/s and from 0.443 to 0.432m, respectively.

Although the number of cases did not reach the planned target and sufficient effect verification was not achieved, only the RE-Gait group showed a tendency toward improvement in walking speed and stride length. This suggests that rehabilitation using an ankle-support walking assistive robot may be effective for patients with walking disabilities due to stroke sequelae.

April. 01, 2025

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs062180099

Mitsuhara Takafumi

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551

mitsuhara@hiroshima-u.ac.jp

Nakagawa Kei

Hiroshima University

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551

+81-82-257-5406

keinakag@hiroshima-u.ac.jp

Complete

Aug. 07, 2017

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Persons with motor paralysis in one side limbs.
2. Persons who are considered to have a small risk of recurrence of the stroke (one or more months have passed since the onset of stroke).
3. Persons who do not have respiratory or cardiovascular disease
4. Persons with mild paralysis of lower limbs (Brunnstrom's recovery stage III or higher).
5. Persons who can walk continuously for about 1 km at the monitoring level (canes and walking aids can be used).
6. Persons who do not allow limitation of the range of motion of the ankle joint.
7. Persons who can participate in walking practice (three times a week, one month).
8. Persons aged 20 to 80 at the time of consent.
9. Person who obtains consent in writing on participation of this study.

1. Persons with severe paralysis of lower limbs (Brunnstrom's recovery stage II or less).
2. Persons who have serious diseases other than the relevant diseases or diseases to be indicated for surgery.
3. Person who was judged to be difficult to participate in research from his / her own physician.
4. Women who are lactating, pregnant or may become pregnant.
5. Others who judged inappropriate by the research staffs.

Both

Cerebrovascular disease

Walking exercise with the walking assistant robot "RE-Gait"(2-4 weeks, 8-14 times x 20 minutes per week) or Walking exercise without the walking assistant robot (2-4 weeks, 8-14 times x 20 minutes per week)

1. Walking speed, Stride length
2. Joint angle of walking (hip, knee, foot)
3. Reciprocal inhibition
4. Somatosensory evoked potential
5. Cortico-muscular coherence

1. Number of occurrences of adverse events
2. Feeling of fatigue and impression of using RE-Gait

+81-82-257-1551

Feb. 13, 2019

none