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
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
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
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
