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Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 2 spinocerebellar degeneration

Rehabilitation trial using curara(R) for patients with spinocerebellar degeneration

20

Twenty patients (male: 8, female: 12) with spinocerebellar ataxia (SCA) and multiple system atrophy with predominant cerebellar ataxia (MSA-C) were enrolled. Disease subtypes were as follows; SCA2: 1, SCA6: 4, SCA31: 3, SCA36: 1, autosomal dominant cerebellar ataxia with genetic testing undone: 4, idiopathic cerebellar ataxia: 2, and MSA-C: 5. The mean age at enrollment was 63.5 years old, Berg Balance Scale (BBS): 40.1, Functional Independence Measure (FIM): 74.1 and Scale for the Assessment and Rating of Ataxia (SARA): 11.3.

One patient dropped out from the study because of his voluntary intention of withdraw on day 3. The other 19 patients completed the program without any adverse events. Out of 19 patients, one was excluded from the analysis due to extreme outliers in most of the measured items, thus, data from 18 patients were analyzed.

No adverse events were observed.

The mean improvement rate of 10 m walking time and 6 min walking distance was 19.0% and 29.0%, respectively. There was no difference in the change of SARA and BBS, but Timed Up & Go improved on day 14 (p = 0.002). All gait parameters obtained by RehaGait, except for the standard deviation of stride length and stride time, improved on day 14.

We conducted a single-arm study using curara for cerebellar ataxia patients. Of 20 patients enrolled, 19 completed the program without any adverse effects and one withdrew on day 3. The mean improvement rate of 10 m walking time in this study was almost equivalent to that in the previous study, which was a multidisciplinary, intensive, inpatient rehabilitation program of 28 days. We think gait training with curara is potentially useful for cerebellar ataxia patients.

Mar. 28, 2020

Undecided

Undecided

https://jrct.niph.go.jp/latest-detail/jRCTs032180164

Yoshida Kunihiro

Shinshu University School of Medicine

3-1-1 Matsumoto 390-8621, Nagano, Japan

kyoshida@shinshu-u.ac.jp

Yoshida Kunihiro

Shinshu University School of Medicine

3-1-1 Matsumoto 390-8621, Nagano, Japan

+81-263-37-3059

kyoshida@shinshu-u.ac.jp

Complete

Oct. 16, 2018

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1) Patients with spinocerebellar degeneration (SCD)
2) Age: 20 years <= at entry
3) Able to walk 10 m (even with walking aids such as cane or walker)
4) Able to keep admission in Kakeyu-Misayama Rehabilitation Center, Kakeyu Hospital during the study
5) Berg Balance Scale: 20 <=
6) Written informed consent for the study

1) Possible causes for gait disturbance other than SCD
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 contractures of the legs)

Both

spinocerebellar degeneration (SCD)

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) SARA (Scale for the Assessment and Rating of Ataxia; SARA)
5) 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