UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036008 |
|---|---|
| Receipt number | R000041013 |
| Scientific Title | The effect of insole insertion on the dynamic stability of young healthy subjects |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2020/03/13 17:28:37 |
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Basic information
Public title
The effect of insole insertion on the dynamic stability of young healthy subjects
Acronym
The effect of insole insertion on dynamic stability
Scientific Title
The effect of insole insertion on the dynamic stability of young healthy subjects
Scientific Title:Acronym
The effect of insole insertion on dynamic stability
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the long term effect of plantar insole usage on dynamic stability of young healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
dynamic stability after 1 month or 2 month of insole usage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1-month insole usage
Interventions/Control_2
2-months insole usage
Interventions/Control_3
control (no insole usage)
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
shoe size between 23cm and 28 cm
experience of regular club sports activity
Key exclusion criteria
low dynamic stability fulfilling chronic ankle instability criteria
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
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 University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Biomedical Engineering
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
IRB Tohoku University School of Medicine
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
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
| 2019 | Year | 02 | 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
18
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
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041013
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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