UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042662 |
|---|---|
| Receipt number | R000048676 |
| Scientific Title | The effect of bandage socks on the dynamic stability of the ankle joint. |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2021/02/09 11:51:07 |
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Basic information
Public title
The effect of bandage socks on the dynamic stability of the ankle joint.
Acronym
Dynamic stability of the ankle joint by bandage socks
Scientific Title
The effect of bandage socks on the dynamic stability of the ankle joint.
Scientific Title:Acronym
Dynamic stability of the ankle joint by bandage socks
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bandage socks are supposed to limit the range of motion of the ankle joints. How they affect the dynamic stability of the ankle joint, one of the major risk factors of ankle joint injury, is not clarified. The purpose of the study is to elucidate the effect of wearing bandage socks on the dynamic stability of ankle joints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dynamic stability will be evaluated from ground reaction force measurement during 8 directional hopping movements.
Key secondary outcomes
Static stability will be evaluated from COP fluctuation during standing on a forceplate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing bandage socks for 1 month more than 8 hours/day.
Interventions/Control_2
No treatment 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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Shoe size between 22.5 cm and 28 cm
Having experiences in a club-sports activity.
Key exclusion criteria
1.Chronic ankle instability
2.Surgical history of lower limb neuromusculoskeletal system
3.Malalignment of lower limb or hip due to fracture or malformation which requires surgical intervention
4. Acute injury of lower limbs or hip that prohibited participation in any exercise more than a week within 3 months before the participation in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku Univerisity
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku Univerisity
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 12 | Month | 05 | 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
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 | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048676
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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