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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026301
Receipt No. 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

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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
Email 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
Email sshibata@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
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 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
URL(English) https://upload.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


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