Unique ID issued by UMIN | UMIN000034238 |
---|---|
Receipt number | R000038941 |
Scientific Title | Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 2 spinocerebellar degeneration |
Date of disclosure of the study information | 2018/10/02 |
Last modified on | 2022/03/31 19:59:08 |
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
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
Japan |
spinocerebellar degeneration (SCD)
Neurology |
Others
NO
The aim of this study is to verify the efficacy and safety of the short-term, inpatient rehabilitation (gait training) using curara(R) for SCD patients.
Safety,Efficacy
Exploratory
10m walking speed (comparison between day 0 and day 14) [day 0, day 7, day 14]
[] indicates day of evaluation
1) 6-min walking distance (comparison between day 0 and day 14)
2) RehaGait(R) measures
3) Berg Balance Scale (BBS) [day 0, day 14]
4) Timed up and go test
5) Scale for the Assessment and Rating of Ataxia (SARA)
6) Outcome measures reported by participants [day 14]
7) Safety sheet (interview to participants) [at least 1 day during 3 days just prior to day 0, and day 0-day 14]
Items not specified above by [] are evaluated three times, day 0, day 7, and day 14.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
gait training using curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]
20 | years-old | <= |
Not applicable |
Male and Female
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)
20
1st name | Kunihiro |
Middle name | |
Last name | Yoshida |
Shinshu University School of Medicine
Department of Brain Disease Research
390-8621
3-1-1 Asahi, Matsumoto 390-8621, Japan
0263-37-3059
kyoshida@shinshu-u.ac.jp
1st name | Kunihiro |
Middle name | |
Last name | Yoshida |
Shinshu University School of Medicine
Department of Brain Disease Research
390-8621
3-1-1 Asahi, Matsumoto 390-8621, Japan
0263-37-3059
kyoshida@shinshu-u.ac.jp
Shinshu University
Japan Agency for Medical Research and
Development (AMED)
Japanese Governmental office
Shinshu University
3-1-1 Asahi, Matsumoto 390-8621, Japan
0263-37-2572
mdrinri@shinshu-u.ac.jp
NO
JA厚生連 鹿教湯三才山リハビリテーションセンター鹿教湯病院(長野県)
2018 | Year | 10 | Month | 02 | Day |
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000038941
Published
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000038941
20
Because one patient showed extremely outlier values on the major outcome measures, we excluded her from analysis and analyzed 18 patients. The averaged improvement rates of 10 m walking time and 6 min walking distance were 19.0 % and 29.0 %, respectively. As to the secondary outcome measures obtained by RehaGait, the improvements of cadence, stride length, stride time, ratio of swing phase, and maximum flexion angles of hip and knee joints were statistically significant between day 0 and day 14.
2022 | Year | 03 | Month | 31 | Day |
20 patients (male: 8; female 12) with spinocerebellar degeneration (SCD). Age at entry: 45-84 years (mean 63.5 years), BBS: 27-53 (mean 40.1), FIM: 52-89 (mean 74.1), SARA: 2.0-19.5 (mean 11.3).
All the patients, except one who dropped out during the study, completed the program.
Nothing specified.
improvement rate of 10 m walking time
improvement rate of 6 min walking distance
Completed
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 02 | Day |
2018 | Year | 10 | Month | 09 | Day |
2020 | Year | 01 | Month | 15 | Day |
2018 | Year | 09 | Month | 22 | Day |
2022 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038941
Research Plan | |
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Registered date | File name |
2022/03/31 | 研究計画書(脊髄小脳変性症)ver.10.5_121319.docx |
Research case data specifications | |
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Registered date | File name |
2022/03/31 | SCD_研究症例データ仕様書(吉田邦広)033122.xlsx |
Research case data | |
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Registered date | File name |
2022/03/31 | SCD_研究症例データ(吉田邦広)033122.xlsx |