UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052194 |
|---|---|
| Receipt number | R000059492 |
| Scientific Title | Relationship between static and dynamic subjective visual vertical and balance function in healthy older adults |
| Date of disclosure of the study information | 2023/10/08 |
| Last modified on | 2025/04/15 09:21:23 |
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Basic information
Public title
Relationship between static and dynamic subjective visual vertical and balance function in healthy older adults
Acronym
Relationship between vestibular function and balance function in older adults
Scientific Title
Relationship between static and dynamic subjective visual vertical and balance function in healthy older adults
Scientific Title:Acronym
Relationship between subjective visual vertical and balance function in healthy older adults
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the reliability of static and dynamic SVV in healthy older adults using VR method with VR goggles and smartphone application, and to clarify the relationship with balance function.
Basic objectives2
Others
Basic objectives -Others
Verification of relationship between dynamic SVV and balance function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static and dynamic subjective visual vertical
Key secondary outcomes
Mini-BESTest
Upright balance assessment based on the force plate (total path length, amplitude, etc.)
MMSE
Age
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those without significant ophthalmologic, otologic, neurologic, or musculoskeletal disorders.
No self-reported hearing loss, headache, migraine, neck pain, or dizziness.
Key exclusion criteria
Persons with cognitive impairments.
Those taking medications known to affect the vestibular system.
Those who have consumed alcohol within the past 24 hours.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Hayashi |
Organization
Gunma Paz University
Division name
Department of Physical Therapy
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki, Gunma
TEL
027-365-3366
mane.shota@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Hayashi |
Organization
Gunma Paz University
Division name
Department of Physical Therapy
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki, Gunma
TEL
027-365-3366
Homepage URL
s-hayashi@paz.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Shota Hayashi
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee of Gunma Paz University
Address
1-7-1 Tonyamachi, Takasaki, Gunma
Tel
027-365-3366
s-hayashi@paz.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
群馬パース大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
This study was a single-center, cross-sectional observational study of 50 healthy older adults.
A multivariate analysis was conducted with balance function as the dependent variable and age, height, static SVV, and visual dependence as the independent variables.
The results suggested that visual dependence was significantly associated with static standing balance (mean sway velocity in the lateral direction) in the eyes-closed and form-on conditions.
Results date posted
| 2025 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Subjective visual verticals; static, dynamic
Visual dependence
Mini-BEStest
stabilometry; sway path, amplitude, mean sway velocity
MMSE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we are conducting a cross-sectional study to investigate the relationship between subjective visual vertical position and balance function in community-dwelling, healthy older adults. To this end, the following information will be collected.
Basic Information
Age, gender, height, weight, dominant hand, medication information, cognitive function (MMSE)
Balance function
Mini-BESTest, Total path length, amplitude, etc. according to 6 conditions(eye opening/hard surface, eye closing/hard surface, eye opening/soft surface, eye closing/soft surface, optokinetic stimulation (left/right torsional stimulation)/hard surface).
The conventional bucket method has been used to measure SVV. However, the Virtual Reality (VR) method has attracted attention in recent years because it can easily measure not only static SVV but also dynamic SVV.
Therefore, to verify the reliability of the measurement, only the SVV measurement will be re-measured after one week. Relative reliability (intraclass correlation coefficient) and absolute reliability (Minimum Detectable Change: MDC) will then be verified. The relationship between the SVV measured in the initial assessment and the balance function will be verified.
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059492
