UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036161 |
|---|---|
| Receipt number | 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 | 2023/04/21 12:02:39 |
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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 | Ikuko |
| Middle name | |
| Last name | Okuni |
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
satoru.ebihara@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Okuni |
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
satoru.ebihara@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
pon1990@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
Completed
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
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041199
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
