UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028832 |
|---|---|
| Receipt number | R000033000 |
| Scientific Title | Effects of vestibular rehabilitation exercise for chronic vertigo/dizziness patients |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2017/08/25 16:19:14 |
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Basic information
Public title
Effects of vestibular rehabilitation exercise for chronic vertigo/dizziness patients
Acronym
Effects of vestibular rehabilitation
Scientific Title
Effects of vestibular rehabilitation exercise for chronic vertigo/dizziness patients
Scientific Title:Acronym
Effects of vestibular rehabilitation
Region
| Japan |
Condition
Condition
Chronic vertigo/dizziness
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effects of vestibular rehabilitation
Basic objectives2
Others
Basic objectives -Others
Vestibular functional tests and questionnaires are statistically compared between before and after vestibular rehabilitation.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Vestibular functional tests and questionnaires are statistically compared between just before and 6 months after vestibular rehabilitation.
Key secondary outcomes
Vestibular functional tests and questionnaires are statistically compared between just before and more than 24 months after vestibular rehabilitation.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with persistent chronic vertigo/dizziness and enthusiasm of vestibular rehabilitation are included.
Key exclusion criteria
Patients without symptoms of chronic vertigo/dizziness or hope of vestibular rehabilitation are excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Kitahara |
Organization
Nara Medical University
Division name
Otolaryngology, Head & Neck Surgery
Zip code
Address
840 Shijo-cho, Kashihara-city, Nara
TEL
0744-20-3051
tkitahara@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taeko Ito |
Organization
Nara Medical University
Division name
Otolaryngology, Head & Neck Surgery
Zip code
Address
840 Shijo-cho, Kashihara-city, Nara
TEL
0744-20-3051
Homepage URL
http://www.naramed-u.ac.jp/~oto/specialty_01.html
taeito@naramed-u.ac.jp
Sponsor or person
Institute
Otolaryngology, Head & Neck Surgery
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Department of Otolaryngology, Osaka City University, School of Medicine
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
奈良県立医科大学附属病院（奈良県）
Otolaryngology, Head&Neck Surgery, Nara Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.naramed-u.ac.jp/~oto/specialty_01.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.naramed-u.ac.jp/~oto/specialty_01.html
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
We evaluate the treatment effects of vestibular rehabilitation by means of the vestibular exams: PTA/SDT, caloric, SVV, VEMP, vHIT, GBST, endolymphatic hydrops tests and questionnaires.
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033000
