UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026301 |
|---|---|
| Receipt number | R000030207 |
| Scientific Title | Reliability of The Toronto Bedside Swallowing Screening Test (TOR-BSST) for dysphagia screening |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/08/27 11:43:15 |
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Basic information
Public title
Reliability of The Toronto Bedside Swallowing Screening Test (TOR-BSST) for dysphagia screening
Acronym
Reliability of TOR-BSST
Scientific Title
Reliability of The Toronto Bedside Swallowing Screening Test (TOR-BSST) for dysphagia screening
Scientific Title:Acronym
Reliability of TOR-BSST
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the interrater reliability of Japanese translated TOR-BSST of dysphagia screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tongue movement, voice quality, existence of cough, voice quality change, and drooling during and after water swallowing test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
implementation of swallowing screening
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
All new patients who admitted to A-8S (SCU) of Fujita Health University hospital.
Those who are 20 or more than 20 years old when consent was acquired.
Key exclusion criteria
1. those who are not medically stable
2. those who are on ventilator
3. those who are judged inappropriate by member of research project
4. those who have history of dysphagia
5. those who have history of neurological disease other than stroke
6. those who have history of head and neck surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Saitoh |
Organization
Fujita Health University
Division name
School of Medicine, Department of Rehabilitation Medicine I
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
esaitoh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Shibata |
Organization
Fujita Health University
Division name
School of Medicine, Department of Rehabilitation Medicine I
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
Homepage URL
sshibata@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University research grant
Organization
Division
Category of Funding Organization
Other
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
藤田保健衛生大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
| 2016 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030207
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/27 | TOR-BSST 研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/08/27 | 170516 TOR-BSST信頼性 症例データUMIN.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/08/27 | 170516 TOR-BSST信頼性 症例データUMIN.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/30207
