UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of Vestibular rehabilitation in patients with unilateral vestibular disorder
Title of the study (Brief title)	Vestibular rehabilitation
Region	Japan

Condition
Condition	Examination of vestibular rehabilitation for unilateral vestibular vestibular disorder patient
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As a part of the treatment for patients with dizziness, vestibular rehabilitation attracts attention. It has been commonly carried out by the cooperation between a physician and a physical therapist in the United States since the 20th century. However in Japan, it is not sufficiently spread because it is not possible to obtain medical scores and difficult to cooperate with physical therapists. In order to overcome the current situation, it is necessary to collaborate with physical therapists on the efficacy of physiotherapy and evaluate the efficacy of vestibular rehabilitation quantitatively and over time to confirm the importance and prepare a flexible and concise program. On that basis, we consider the application of insurance treatment for vestibular rehabilitation and development of its treatment as the ultimate goal for the future aging society, where dizziness patients are expected to increase.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A prospective study Initially, informed consent is executed according to consent explanation document to subjects who wish to participate in this research. If participants wish to undergo rehabilitation at the rehabilitation office, they are classified as an intervention group. If they do not wish to rehabilitate in the rehabilitation office, they are classified as a non-intervention group, and carry out rehabilitation only with rehabilitation guidance by doctors and nurses as before.
Key secondary outcomes	We examine Nystagmus findings, HADS, STAI. With the motor function being secured by Barthel Index, we also evaluate the trajectory length, total area, Short Physical Performance Battery, Functional Gait index, Time up and Go with gravity sway meter. If possible, we'd like to examine maximal slow aspect speed of the nystagmus, CP% of the electronystagmogram(ENG), an amplitude right and left ratio of cVEMP.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	We will examine the items mentioned above at the time of the initial otolaryngology consultation (or at the start of rehabilitation), at the time of discharge (or one week after the start of rehabilitation), and, 1, 3, and 6 months after the initial consultation. Items that are difficult to implement at the time of initial visit are eliminated, items with high necessity are selected according to disease condition, and medical examination takes 40-60 minutes per person.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Unilateral vestibular disorders such as idiopathic hearing loss with vertigo, vestibular neuritisvestibular neuronitis
Key exclusion criteria	Target patient with general condition and medical history incapable of enforcement of vestibular rehabilitation
Target sample size	20

Research contact person
Name of lead principal investigator	yutaro ida
Organization	Toho University Omori Medical Center
Division name	Otorhinolaryngology
Address	Ota-ku, Tokyo Shimomaruko 2-26-12
TEL	090-3592-7599
Email	yutaro.ida@med.toho-u.ac.jp

Public contact
Name of contact person	Omori Medical Center Ethics Committee
Organization	Toho University Omori Medical Center
Division name	Omori Medical Center Ethics Committee
Address	Ota-ku, Tokyo Omorinishi 6-11-1
TEL	03-3762-4151
Homepage URL
Email	omori.rinri@toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 03 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 02 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037585