UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013492 |
|---|---|
| Receipt number | R000015765 |
| Scientific Title | Quantitative evaluation of ataxia using a three-axis accelerometer |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2020/04/01 20:59:12 |
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Basic information
Public title
Quantitative evaluation of ataxia using a three-axis accelerometer
Acronym
Quantitative evaluation of ataxia using a three-axis accelerometer
Scientific Title
Quantitative evaluation of ataxia using a three-axis accelerometer
Scientific Title:Acronym
Quantitative evaluation of ataxia using a three-axis accelerometer
Region
| Japan |
Condition
Condition
Spinocerebellar Degeneration
Multiple System Atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish quantitative evaluation method of ataxia in patients with spinocerebellar degeneration and multiple system atrophy.
Basic objectives2
Others
Basic objectives -Others
SARA, which is currently used for evaluation of ataxia, has some problems.
The amount of change in score is particularly low especially in early stage of diseases, and
SARA is not completely objective method.
In this study, we are planning to establish the objective and simple evaluation method of ataxia using a measuring instrument that can detect upset of a body sensitively.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The extent of the upset of the trunk seen in motion a predetermined
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with spinocerebellar degeneration and multiple system atrophy.
In addtion, normal healthy persons as the control.
Key exclusion criteria
Patients except spinocerebellar degeneration and multiple system atrophy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Shinshu University School of Medicine
Division name
Division of Neurogenetics, Department of Brain Disease Research
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2673
kyoshida@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Matsushima |
Organization
Akira Matsushima
Division name
Department of Neurology and Rheumatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2673
Homepage URL
matsuaki@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Rheumatology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KISSEI COMTEC CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Hospital
Address
Asahi 3-1-1, Matsumoto
Tel
0263-37-2673
shinhp@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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We put a small device to a waist, and that device measure the extent of the upset of body.
After that, we evaluate the degree of the upset between healthy control subjects and patients.
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015765
