UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033249 |
|---|---|
| Receipt number | R000037901 |
| Scientific Title | Clinical study of Dynamic Visual Acuity Test |
| Date of disclosure of the study information | 2018/07/02 |
| Last modified on | 2024/01/06 07:55:41 |
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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 | Tetsuo |
| Middle name | |
| Last name | Ikezono |
Organization
Saitama medical university
Division name
Department of Otorhinolaryngology
Zip code
350-0495
Address
Saitama-ken Iruma-gun Moroyama-cho morohongo 38
TEL
049-276-1296
saitama.kikoe@gmail.com
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Yoshimura |
Organization
Saitama medical university
Division name
Department of Otorhinolaryngology
Zip code
350-0495
Address
Saitama-ken Iruma-gun Moroyama-cho morohongo 38
TEL
049-276-1296
Homepage URL
saitama.kikoe@gmail.com
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
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
IRB of Saitama Medical Hospital
Address
Saitama-ken Iruma-gun Moroyama-cho Morohongo38
Tel
-
-
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
24
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
Completed
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
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
