UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013681
Receipt number R000015965
Scientific Title Reliability tests of Japanese version of the Modified Barthel Index
Date of disclosure of the study information 2014/04/10
Last modified on 2015/04/10 09:35:07

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Basic information

Public title

Reliability tests of Japanese version of the Modified Barthel Index

Acronym

Reliability tests of Japanese version of the MBI

Scientific Title

Reliability tests of Japanese version of the Modified Barthel Index

Scientific Title:Acronym

Reliability tests of Japanese version of the MBI

Region

Japan


Condition

Condition

Stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary aim of this study is to examine inter-rater and intra-rater reliability of Japanese version of MBI.

Basic objectives2

Others

Basic objectives -Others

The secondary aim of this study is to examine correlation between MBI and other well-known scale (Barthel Index).

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Interclass correlation coefficient of MBI total scores

Key secondary outcomes

Kappa coefficient of MBI category scores


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

1. Stroke patients classified to NINDS III
2. Over 20 years old
3. Any gender
4. Agreed by patients or the legal representative
5. Inpatients

Key exclusion criteria

1. Stroke patients with co-morbidities influence patient's ADL
2. Stroke patients with unstable condition
3. Judged unsuitable for the study by principal investigator or sub-investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiya Umeda

Organization

ASAHI KASEI PHARMA CORPORATION

Division name

Clinical Development Department, Development planning

Zip code


Address

1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo, Japan

TEL

03-3296-7081

Email

umeda.tc@om.asahi-kasei.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiya Umeda

Organization

ASAHI KASEI PHARMA CORPORATION

Division name

Clinical Development Department, Development planning

Zip code


Address

1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo, Japan

TEL

03-3296-7081

Homepage URL


Email

umeda.tc@om.asahi-kasei.co.jp


Sponsor or person

Institute

ASAHI KASEI PHARMA CORPORATION

Institute

Department

Personal name



Funding Source

Organization

ASAHI KASEI PHARMA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 10 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

Completed

Date of protocol fixation

2014 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 01 Day

Last follow-up date

2014 Year 07 Month 31 Day

Date of closure to data entry

2014 Year 10 Month 10 Day

Date trial data considered complete

2014 Year 10 Month 31 Day

Date analysis concluded

2014 Year 11 Month 30 Day


Other

Other related information

Examine inter-rater and intra-rater reliability in Japanese version of MBI by evaluating videos of patient's activity of daily life twice during the research period.


Management information

Registered date

2014 Year 04 Month 10 Day

Last modified on

2015 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name