UMIN-CTR Clinical Trial

Public title

A study of Vestibular rehabilitation in patients with unilateral vestibular disorder

Acronym

Vestibular rehabilitation

Scientific Title

A study of Vestibular rehabilitation in patients with unilateral vestibular disorder

Scientific Title:Acronym

Vestibular rehabilitation

Region

Japan

Condition

Examination of vestibular rehabilitation for unilateral vestibular vestibular disorder patient

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	yutaro ida

Organization

Toho University Omori Medical Center

Division name

Otorhinolaryngology

Zip code

Address

Ota-ku, Tokyo Shimomaruko 2-26-12

TEL

090-3592-7599

Email

yutaro.ida@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Omori Medical Center Ethics Committee

Organization

Toho University Omori Medical Center

Division name

Omori Medical Center Ethics Committee

Zip code

Address

Ota-ku, Tokyo Omorinishi 6-11-1

TEL

03-3762-4151

Homepage URL

Email

omori.rinri@toho-u.ac.jp

Institute

Toho University Omori Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

07

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

06

Month

01

Day

Date of IRB

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

Other related information

Registered date

2018

Year

07

Month

02

Day

Last modified on

2018

Year

07

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037585