UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of vestibular rehabilitation exercise for chronic vertigo/dizziness patients
Title of the study (Brief title)	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	Tadashi Kitahara
Organization	Nara Medical University
Division name	Otolaryngology, Head & Neck Surgery
Address	840 Shijo-cho, Kashihara-city, Nara
TEL	0744-20-3051
Email	tkitahara@naramed-u.ac.jp

Public contact
Name of contact person	Taeko Ito
Organization	Nara Medical University
Division name	Otolaryngology, Head & Neck Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 25 Day
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

Related information
URL releasing protocol	http://www.naramed-u.ac.jp/~oto/specialty_01.html
Publication of results	Unpublished
URL releasing results	http://www.naramed-u.ac.jp/~oto/specialty_01.html
Results
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