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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010683
Receipt No. R000012260
Scientific Title Assessment of function of equilibrium and balance using rotating chair
Date of disclosure of the study information 2013/05/10
Last modified on 2016/11/11

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Basic information
Public title Assessment of function of equilibrium and balance using rotating chair
Acronym Assessment of function of equilibrium
Scientific Title Assessment of function of equilibrium and balance using rotating chair
Scientific Title:Acronym Assessment of function of equilibrium
Region
Japan

Condition
Condition normal volunteer and patient complaining vertigo
Classification by specialty
Oto-rhino-laryngology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of functional test of otolith and semicircular canal
Basic objectives2 Others
Basic objectives -Others Analysis of eye movement during rotation
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Gain of vestibulo-ocular reflex
Key secondary outcomes Phase of vestibulo-ocular reflex

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Subjects were rotated by rotating chair during about 20 minutes.
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
3 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Normal volunteers and patients complaining with vertigo
Key exclusion criteria subjects who are thought to be unsuitable for rotating stimulation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Imai
Organization Osaka University Graduate School of Medicine
Division name Otorhinolaryngology - Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3951
Email timai@ent.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Imai
Organization Osaka University Graduate School of Medicine
Division name Otorhinolaryngology - Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3951
Homepage URL
Email timai@ent.med.osaka-u.ac.jp

Sponsor
Institute Department of Otorhinolaryngology - Head and Neck Surgry, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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
2013 Year 05 Month 10 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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 30 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
2013 Year 05 Month 09 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012260

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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