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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036161
Receipt No. R000041199
Scientific Title Effect of Taste Rehabilitation on patients with taste diturbance
Date of disclosure of the study information 2019/03/11
Last modified on 2019/03/11

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Basic information
Public title Taste Rehabilitation Study
Acronym TRS
Scientific Title Effect of Taste Rehabilitation on patients with taste diturbance
Scientific Title:Acronym ETR
Region
Japan

Condition
Condition Dysgeusia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to apply taste rehabilitation by a speech hearing aid to patients whose awareness of taste disorder and anorexia exists and to evaluate the effect with a taste quantitative test kit with a filter paper disc.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Taste threshold evaluated by taste quantitative test kit with filter paper disc
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 ral care and oral care measures taken as a part of swallowing rehabilitation by linguistic hearing experts, etc., oral cavity stretching and movement of the oral cavity are combined according to the condition of the patient.
Evaluate after about 3 to 6 visits to our outpatient clinic once a week.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Among the adult patients whose cognitive function is normal in the consciousness statement, among the patients who were requested to rehabilitation at Toho University Medical Center Ohmori Hospital Department of rehabilitation medicine (outpatient department of our department is inpatient), we are aware of the taste disorder, Patients who do not know the definite cause of intervention such as treatment
Key exclusion criteria Dementia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Ebihara
Organization Toho University Graduate School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 1438541
Address 6-11-1 Omori-nshi, Ota-ku, Tokyo
TEL 0337624151
Email satoru.ebihara@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Ebihara
Organization Toho University Graduate School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 1438541
Address 6-11-1 Omori-nshi, Ota-ku, Tokyo
TEL 0337624151
Homepage URL
Email satoru.ebihara@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Toho University
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 Ethics committee of Toho University Omori Medical Center
Address 6-11-1 Omori-nshi, Ota-ku, Tokyo
Tel 0337624151
Email satoru.ebihara@med.toho-u.ac.jp

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
2019 Year 03 Month 11 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
2019 Year 03 Month 11 Day
Date of IRB
2018 Year 11 Month 16 Day
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
2024 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 11 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041199

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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