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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015765


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name