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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028832
Receipt No. 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

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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
Email 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
Email taeito@naramed-u.ac.jp

Sponsor
Institute Otolaryngology, Head & Neck Surgery
Nara Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033000

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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