UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012892
Receipt number R000015045
Scientific Title Reliability and validity of Japanese version of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in subacute stroke patients
Date of disclosure of the study information 2014/01/18
Last modified on 2014/01/20 08:05:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Reliability and validity of Japanese version of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in subacute stroke patients

Acronym

Reliability and validity of Japanese version of the Mini-BESTest in stroke patients

Scientific Title

Reliability and validity of Japanese version of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in subacute stroke patients

Scientific Title:Acronym

Reliability and validity of Japanese version of the Mini-BESTest in stroke patients

Region

Japan


Condition

Condition

First-ever stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to examine reliability and validity of Japanese version of the Mini-BESTest as a balance measure for patients with subacute stroke.

Basic objectives2

Others

Basic objectives -Others

A validation study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The scores of Japanese version of the Mini-BESTest

Key secondary outcomes

Other well-known balance measures (functional reach test, timed up & go test and Berg balance scale)


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>
1. First-ever hemiplegic stroke admitted to Tokyo Bay Rehabilitation Hospital.
2.Able to ambulate 6m without human assistance.
3.Able to follow 3-step commands.
4.Able to understand the tasks of Japanese version of the Mini-BESTest.
5.Consent to participate in this study.

Key exclusion criteria

1.Impaired consciousness, severe vision problem, severe hearing loss, severe cognitive dysfunction and/or the dementia.
2.Comorbidities that affect the balance function.
3.Musculoskeletal diseases with severe deformity and/or severe pain.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chisato Kiriyama

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Division of Physical therapy

Zip code


Address

4-1-1 Yatsu,Narashino-shi,Chiba

TEL

047-453-9010

Email

chu_vc4sv_cream@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chisato Kiriyama

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Division of Physical therapy

Zip code


Address

4-1-1 Yatsu,Narashino-shi,Chiba

TEL

047-453-9010

Homepage URL


Email

chu_vc4sv_cream@yahoo.co.jp


Sponsor or person

Institute

Tokyo Bay Rehabilitation Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Rehabilitation Medicine, Keio University School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京湾岸リハビリテーション病院
Tokyo Bay Rehabilitation Hospital


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 18 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

Enrolling by invitation

Date of protocol fixation

2013 Year 12 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 18 Day

Last follow-up date

2015 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.Inter-rater reliability is tested by intraclass correlation coefficient.
2.Internal consistency is evaluated using Cronbach's alpha.
3.Concurrent validity is examined by correlation coefficients between Japanese version of the Mini-BESTest and well-known balance measures (functional reach test,timed up&go test,Berg balance scale).


Management information

Registered date

2014 Year 01 Month 18 Day

Last modified on

2014 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name