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Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 1 cerebrovascular disease

Rehabilitation trial using curara(R) for patients with cerebrovascular diseases

40

Forty adult patients (male: 28; female: 12) with cerebrovascular diseases (cerebral infarction: 20; cerebral hemorrhage: 20) who showed hemiplegia were enrolled. The mean age of the patients was 64.5 years old. The patients' profiles were as follows: Functional Independent Measure (FIM) was 74.3 (mean), 12 grading scale (Ueda style single paralysis function tests) was 10.7 (mean), and 10m walking time was 12.5 sec (mean). These patients were randomly classified into two study groups, Group A with curara and Group B without curara.

Out of 40 patients, 4 patients were dropped out from the study. 3 were from Group A and 1 was from Group B, respectively. One patient who dropped out from Group A developed skin problem by wearing curara and the other two intended to retract their consent to the study. One patient from Group B developed cerebral hemorrhage again during the study. Thirty six patients completed the study without any particular problems.

One patient who dropped out from Group A developed skin problem in the outside of her knee joints, thus, the physician in charge wanted to cease the study. We judged to stop the study in one patient in Group B because she developed cerebral hemorrhage again during the study.

We analyzed data from 36 patients in total (Group A: 17; Group B: 19). But one patient in Group B showed extraordinary data compared with the other patients in the same group, therefore we excluded this patient from analysis. We set two primary outcome measures, improvement rates for 10 m walking time and 6-min walking distance. The mean improvement rate for 10 m walking time was 0.21 for Group A, and 0.14 for Group B, respectively (p = 0.099). The mean improvement rate for 6-min walking distance was 0.17 for Group A, and 0.19 for Group B, respectively (p = 0.677). The mean change for Berg Balance Scale (BBS) was 1.3 for Group A and 2.6 for Group B (p = 0.087) and that of timed up & go time was -1.4 sec for Group A and -1.3 sec for Group B (p = 0.854), respectively. The secondary outcome measures taken by RehaGait included stride duration, stride length, gait speed, cadence, rate of stance, and maximum angles of hip and knee joints. As a whole, Group A tended to show better results in these gait parameters than Group B, but the difference was not statistically significant.

We failed to find any statistically significant differences in the primary and secondary outcome measures between two groups. It is likely 10 m walking time is the best candidate for the primary outcome measure, but the baseline characteristics or entry criteria should be reconsidered more carefully.

Dec. 21, 2020

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs032180163

Yoshida Kunihiro

Shinshu University School of Medicine

3-1-1 Asahi, Matsumoto 390-8621, Nagano Pref., Japan

kyoshida@shinshu-u.ac.jp

Yoshida Kunihiro

Shinshu University School of Medicine

3-1-1 Asahi, Matsumoto 390-8621, Nagano Pref., Japan

+81-263-37-3059

kyoshida@shinshu-u.ac.jp

Complete

Oct. 03, 2018

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients with cerebrovascular disease (CVD) presenting with hemiplegia
2) Age: 20 years <= at entry
3) Duration after onset ranges from 14 to 90 days
4) Able to walk 10 m (even with walking aids such as cane or walker)
5) Able to keep admission in Kakeyu-Misayama Rehabilitation Center, Kakeyu Hospital during the study
6) Berg balance Scale: 26<=
7) Written informed consent for the study

1) Possible causes for gait disturbance other than CVD
2) Not fulfil the body-size criteria for curara(R) model 4
3) Researchers judge the participants inappropriate for the study (for example, severe dementia or psychiatric symptoms, severe spasticity or joint contracture of paralyzed leg, etc.)

Both

cerebrovascular disease (with hemiplegia)

gait training using curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]

1) 10m walking speed (comparison between day 0 and day 14)
2) 6-min walking distance (comparison between day 0 and day 14)

1) RehaGait(R) measures
2) Berg Balance Scale (BBS) [day 0, day 14]
3) Timed up and go test
4) Outcome measures reported by participants [day 14]

Items not specified above by [] are evaluated three times, day 0, day 7, and day 14.

+81-263-37-2572

Jan. 07, 2019

none