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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012892
Receipt No. 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

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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
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

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
URL(English) https://upload.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


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