UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049227 |
|---|---|
| Receipt number | R000056066 |
| Scientific Title | Effect of training with whole body vibration for 6 weeks on ankle motor control in functional test |
| Date of disclosure of the study information | 2022/10/23 |
| Last modified on | 2023/07/15 10:55:04 |
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Basic information
Public title
Effects of training with whole-body vibration on ankle joint functions in functional balance test
Acronym
Effects of whole body vibration on ankle joint in a balance test
Scientific Title
Effect of training with whole body vibration for 6 weeks on ankle motor control in functional test
Scientific Title:Acronym
Effect of training with whole body vibration on ankle motor control
Region
| Japan |
Condition
Condition
healthy person (university student)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of training using whole-body vibration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle average angular jerk cost in star excursion balance tests
(6 weeks after the start of training)
Key secondary outcomes
(1)Ankle joint proprioception (Absolute error, variation error)
(2)Dorsiflexion angle of ankle joint
(3)Reachable distance in star excursion balance test
(4)Angles in the star excursion balance test
(6 weeks after the start of training)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Training with whole-body vibration stimulation: 4 training items (standing on tiptoe, right and left tandem positions, standing on one leg) twice a week for 6 weeks on a whole-body vibration stimulator.
Interventions/Control_2
Normal training: 4 training items (standing on tiptoe, right and left tandem positions, standing on one leg) twice a week for 6 weeks on normal surface.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No history of surgery involving the lower extremities or spine, pain that interferes with daily activities, or paralysis
Key exclusion criteria
History of surgery in the lower extremities or spine, pain or paralysis that interferes with daily activities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa Prefecture
TEL
0762291161
ry_miyachi@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa Prefecture
TEL
0762291161
Homepage URL
ry_miyachi@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuriku University
Address
1-1 Taiyougaoka, Kanazawa City, Ishikawa Prefecture
Tel
0762291161
ry_miyachi@hokuriku-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
| 2022 | Year | 10 | Month | 23 | 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
| 2022 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056066
