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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012875
Receipt No. R000015043
Scientific Title The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke.
Date of disclosure of the study information 2014/01/16
Last modified on 2014/01/22

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Basic information
Public title The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke.
Acronym The longitudinal changes in balance function in patients with hemiplegic subacute stroke.
Scientific Title The longitudinal changes in balance function evaluated by the Mini-Balance Evaluation Systems Test (Mini-BESTest) in patients with hemiplegic subacute stroke.
Scientific Title:Acronym The longitudinal changes in balance function in patients with hemiplegic subacute stroke.
Region
Japan

Condition
Condition Hemiplegic stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate balance function longitudinally and comprehensively in patients with hemiplegic subacute stroke by the Mini-BESTest and to examine relationship between balance function and activities of daily living (ADL), other physical indices and falls.
Basic objectives2 Others
Basic objectives -Others relevancy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The scores of Mini-BESTest at admission and discharge.
Key secondary outcomes At admission and discharge

Indices of physical function (Stroke Impairment Assessment Sets, gait speed etc) .

Other well-known balance measures (Berg Balance Scale etc).

Activities of daily living (Functional Independence Measure).

Number of falls during hospitalization.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.First-ever hemiplegic stroke admitted to Tokyo Bay Rehabilitation Hospital.
2.Ability to follow 3-step commands.
3.Ability to understand the instruction of the tasks of Mini-BESTest.
4.Provide written informed consent form.
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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emiko Tan
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 emiko07254@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Tan
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 emiko07254@gmail.com

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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(千葉県)
Tokyo Bay Rehabilitation Hospital(Chiba)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 16 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 19 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The relationship of the Mini-BESTest and other indices of physical function, ADL and falls.
The comparison of validity and responsiveness of the Mini-BESTest and other well-known balance measures (Berg Balance Scale etc).

Management information
Registered date
2014 Year 01 Month 16 Day
Last modified on
2014 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015043

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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