UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014130
Receipt number R000016453
Scientific Title Development of dizziness rehabilitation method using sound localization, somatic sensory and visual input
Date of disclosure of the study information 2014/06/03
Last modified on 2018/03/12 17:47:15

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Basic information

Public title

Development of dizziness rehabilitation method using sound localization, somatic sensory and visual input

Acronym

Development of dizziness rehabilitation method

Scientific Title

Development of dizziness rehabilitation method using sound localization, somatic sensory and visual input

Scientific Title:Acronym

Development of dizziness rehabilitation method

Region

Japan


Condition

Condition

adult healthy volunteers

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study the effects of visual stimulation on the plasticity of the otolith-ocular reflex

Basic objectives2

Others

Basic objectives -Others

Application to rehabilitation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of phase and gain

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Visual stimulus moves in the same direction as the rotation of the chair.

Interventions/Control_2

Visual stimulus moves in the opposite direction to the rotation of the chair.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

adult healthy people

Key exclusion criteria

People with a history of dizziness or hearing loss in the past

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Izumi koizuka

Organization

St. Mariannna University, School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

044-977-8111

Email

m2akutsu@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masatoshi Akutsu

Organization

St. Mariannna University, School of Medicine

Division name

Department of Otolaryngology

Zip code


Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa

TEL

044-977-8111

Homepage URL


Email

m2akutsu@marianna-u.ac.jp


Sponsor or person

Institute

St. Mariannna University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

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

2014 Year 06 Month 03 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0385814615002175

Number of participants that the trial has enrolled


Results

There was no significant difference in gain before or after adaptation using the X2 adaptation paradigm.
VOR gain decreased significantly after adaptation using the X0 adaptation paradigm.

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

Enrolling by invitation

Date of protocol fixation

2013 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 19 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

2014 Year 05 Month 31 Day

Last modified on

2018 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016453


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name