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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014130
Receipt No. 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

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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
Institute St. Mariannna University, School of Medicine
Institute
Department

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
URL(English) https://upload.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


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