UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012875
Receipt number 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 01:08:22

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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 or person

Institute

Tokyo Bay Rehabilitation Hospital

Institute

Department

Personal name



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

Value
https://center6.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