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 |
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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
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
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
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
