UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048840 |
|---|---|
| Receipt number | R000055651 |
| Scientific Title | Training Effects of Whole Body Vibration for Chronic Ankle Instability |
| Date of disclosure of the study information | 2022/09/06 |
| Last modified on | 2023/07/15 11:04:30 |
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Basic information
Public title
Whole body vibration training for ankle instability
Acronym
Vibration training for ankle instability
Scientific Title
Training Effects of Whole Body Vibration for Chronic Ankle Instability
Scientific Title:Acronym
Training effects of whole body vibration for CAI
Region
| Japan |
Condition
Condition
Basketball university student with chronic ankle instability
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of training effect by whole body vibration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average angular jerk cost of the ankle joint in the star excursion balance test (immediately after intervention)
Key secondary outcomes
Ankle proprioception (absolute error, variable error)(immediately after intervention)
Ankle dorsiflexion angle under weight-bearing (immediately after intervention)
Ankle joint angle in star excursion balance test(immediately after intervention)
Maximum reach distance in star excursion balance test(immediately after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
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
Whole body vibration (Heel-raising, tandem standing, single-leg standing) (60 sec. x 4 times, rest time 45 sec. each). Remeasured immediately after intervention
Interventions/Control_2
Control
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) history of at least one ankle sprain, (2) recurrent pain, swelling, instability, etc., (3) recurrent giving way, (4) CAIT score less than 25 points
Key exclusion criteria
Patients who complain of pain that interferes with daily life except at the ankle joint, have typical physical disabilities due to cerebrovascular disorders or rheumatoid arthritis, or have a history of ankle sprain other than an ankle sprain such as fracture in the hip or lower limb.
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
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 | 09 | Month | 06 | 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
31
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 | 03 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | 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 | 09 | Month | 02 | 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=R000055651
| 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 |
