UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031669 |
|---|---|
| Receipt number | R000036117 |
| Scientific Title | Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision |
| Date of disclosure of the study information | 2018/03/12 |
| Last modified on | 2024/03/25 09:25:46 |
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Basic information
Public title
Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision
Acronym
Vestibular rehabilitation using multimodal sensation
Scientific Title
Development of rehabilitation for diziness handicaped using sound location, somatosensory, and vision
Scientific Title:Acronym
Vestibular rehabilitation using multimodal sensation
Region
| Japan |
Condition
Condition
Peripheral vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We propose efficient exercise therapy using multimodal sensory inputs for vestibular dysfunction patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gain and phase of vestibulo-ocular refrection in earth-vertical axis rotation and off--vertical axis rotation with stimulation of audition, somatosensory and vision
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects are stimulated by rotating chair with sinusoidal rotation on the earth vertical axis rotation and the off vertical axisrotation. The stimulation duration is 3 minutes for eye movement measurement and 15 minutes for adaptation. Measurements are conducted from 2 to 6 times, and the overall experiment time is from 1 hour to 1 hour 30 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who have never got otologistic symptoms
Key exclusion criteria
Subject who shows symptoms of other than otological disease, judged that he or she can not participate in the examination, and judged that he or she is not healthy adults.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Koizuka |
Organization
St. Marianna University School of Medicine
Division name
Medical department, otorhinolaryngology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
koizuka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | Ohno |
| Last name | Kato |
Organization
St. Marianna University School of Medicine
Division name
Medical department, otorhinolaryngology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
TEL
044-977-8111
Homepage URL
yumiko_o_kato@cwk.zaq.ne.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki 216-8511 Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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 | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
To estimate the effect of multi-modal vestibular rehabilitation, we are attempting to
integrate modalities in location perception using the semicircular ocular reflex (ScOR).
Experiments using visual stimulus, we found that ambiguity in spatial position in vision affects ScOR.(XXXI Barany Society Meeting 2022)
Results date posted
| 2020 | Year | 09 | Month | 16 | Day |
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036117
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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