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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033249
Receipt No. R000037901
Scientific Title Clinical study of Dynamic Visual Acuity Test
Date of disclosure of the study information 2018/07/02
Last modified on 2020/06/18

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Basic information
Public title Clinical study of Dynamic Visual Acuity Test
Acronym Clinical study of Dynamic Visual Acuity Test
Scientific Title Clinical study of Dynamic Visual Acuity Test
Scientific Title:Acronym Clinical study of Dynamic Visual Acuity Test
Region
Japan

Condition
Condition vestibular disorder
Classification by specialty
Neurology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the vestibular function in the patients of the vestibular disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
Key secondary outcomes

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 An Examiner is stand behind an patient.
After hold his/her head, shake his/her head at a rate of about two Hertz.
And, a patient gets a vision test while he/she walks on treadmill in 1-4 km/h.
We examine how much their vision gets worse with head shaking.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with dizziness/vertigo who visit the department of Otorhinolaryngology and Neuro-Otology of Saitama Medical University Hospital
Key exclusion criteria total blindness
people who do not follow the instructions
people who do not consent to our study
people who have difficulty in neck flexion or neck rotation because of cervical disease and severe carotid arteriosclerosis with unstable plaque
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Ikezono
Organization Saitama medical university
Division name Department of Otorhinolaryngology
Zip code
Address Saitama-ken Iruma-gun Moroyama-cho morohongo 38
TEL 049-276-1296
Email saitama.kikoe@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimura Miho
Organization Saitama medical university
Division name Department of Otorhinolaryngology
Zip code
Address Saitama-ken Iruma-gun Moroyama-cho morohongo 38
TEL 049-276-1296
Homepage URL
Email saitama.kikoe@gmail.com

Sponsor
Institute Saitama medical university
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 02 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
2018 Year 08 Month 20 Day
Date of IRB
2018 Year 08 Month 20 Day
Anticipated trial start date
2018 Year 08 Month 21 Day
Last follow-up date
2023 Year 04 Month 30 Day
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
2020 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037901

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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