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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034238
Receipt No. 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 2019/03/25

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Basic information
Public title Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 2 spinocerebellar degeneration
Acronym Rehabilitation trial using curara(R) for patients with spinocerebellar degeneration
Scientific Title Rehabilitation trial using robotic wear curara(R) for patients with cerebrovascular and neurodegenerative diseases. part 2 spinocerebellar degeneration
Scientific Title:Acronym Rehabilitation trial using curara(R) for patients with spinocerebellar degeneration
Region
Japan

Condition
Condition spinocerebellar degeneration (SCD)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10m walking speed (comparison between day 0 and day 14) [day 0, day 7, day 14]
[] indicates day of evaluation
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 gait training using curara(R) (25-35 min/day, 12 days in total) [day 1-day 6, day 8-day 13]
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kunihiro
Middle name
Last name Yoshida
Organization Shinshu University School of Medicine
Division name Department of Brain Disease Research
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263-37-3059
Email kyoshida@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Yoshida
Organization Shinshu University School of Medicine
Division name Department of Brain Disease Research
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263-37-3059
Homepage URL
Email kyoshida@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and
Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 10 Month 02 Day
Anticipated trial start date
2018 Year 10 Month 09 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 22 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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