UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039748 |
|---|---|
| Receipt number | R000045333 |
| Scientific Title | Effects of galvanic vestibular stimulation on subjective postural vertical |
| Date of disclosure of the study information | 2020/03/09 |
| Last modified on | 2024/03/18 10:27:01 |
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Basic information
Public title
The perception of body orientation by galvanic vestibular stimulation
Acronym
The perception of body orientation by galvanic vestibular stimulation
Scientific Title
Effects of galvanic vestibular stimulation on subjective postural vertical
Scientific Title:Acronym
Effects of galvanic vestibular stimulation on subjective postural vertical
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of galvanic vestibular stimulation on the subjective postural vertical
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective postural vertical
(before, during, and after stimulation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
galvanic vestibular stimulation (anode : right side)
Interventions/Control_2
galvanic vestibular stimulation (anode : left side)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
over 20 years old
under 80 years old
no history of orthopaedic disease or neurological disorder
no dementia or psychiatric disorder
able to understand instructions
Key exclusion criteria
not able to provide informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Juntendo university
Division name
Faculty of health science
Zip code
113-0033
Address
3-2-12, hongo, bunkyo-ku, Tokyo, Japan
TEL
+81-13-3111
y.fujino.pb@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Juntendo university
Division name
Faculty of health science
Zip code
113-0033
Address
3-2-12, hongo, bunkyo-ku, Tokyo, Japan
TEL
+81-13-3111
Homepage URL
y.fujino.pb@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo metropolitan university
Address
7-2-10, Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
+81338191211
rinri-hs@mu.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
| 2020 | Year | 03 | Month | 09 | 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
20
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
| 2020 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045333
