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

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 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


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

Value
https://center6.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