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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033247
Receipt No. R000037585
Scientific Title A study of Vestibular rehabilitation in patients with unilateral vestibular disorder
Date of disclosure of the study information 2018/07/03
Last modified on 2018/07/02

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Basic information
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
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
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

Public contact
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

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)

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

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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

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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