UMIN-CTR Clinical Trial

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
Email	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
Email	matsuaki@shinshu-u.ac.jp

Sponsor
Institute	Department of Neurology and Rheumatology, Shinshu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015765