UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041897 |
|---|---|
| Receipt number | R000047821 |
| Scientific Title | Study on the effect of vestibular training on balance ability |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2023/03/30 00:04:39 |
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Basic information
Public title
Study on the effect of vestibular training on balance ability
Acronym
Study on the effect of vestibular training on balance ability
Scientific Title
Study on the effect of vestibular training on balance ability
Scientific Title:Acronym
Study on the effect of vestibular training on balance ability
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of one month of vestibular training intervention on balance ability in healthy individuals without dizziness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in balance ability before and after intervention
Key secondary outcomes
Changes in vestibular function, lower limb muscle strength, one-leg standing retention time, cognitive function, and dynamic visual acuity before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Vestibular training
Interventions/Control_2
Normal daily life
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.MIPS Z score is 0 or less
2.20 to 65 years old at the start of intervention
3.No visual or limb movement disorders
4.No significant locomotor disorders such as fractures or ligament injuries on the trunk or lower limbs
5.There is no peripheral neuropathy, and an upright posture is possible on the spot.
6.No dizziness or hearing loss, and no history of hospital visits
7.No dizziness of rotation or sway due to head reposition
8.Walking and daily life are independent and have no restrictions
Key exclusion criteria
Persons who did not obtain the consent of the individual for this study, or the consent of the parent or guardian in the case of minors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Hada |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3795
tsubaki2308@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tsubaki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba
TEL
029-853-3795
Homepage URL
tsubaki2308@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba
Tel
029-853-3795
tsubaki-2308@gmail.com
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 | 09 | Month | 25 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
