UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046071 |
|---|---|
| Receipt number | R000052581 |
| Scientific Title | The effectiveness and safety of insoles in the prevention of sports injuries |
| Date of disclosure of the study information | 2021/11/16 |
| Last modified on | 2021/11/15 11:22:08 |
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Basic information
Public title
The effectiveness and safety of insoles in the prevention of sports injuries
Acronym
The effectiveness and safety of insoles in the prevention of sports injuries
Scientific Title
The effectiveness and safety of insoles in the prevention of sports injuries
Scientific Title:Acronym
The effectiveness and safety of insoles in the prevention of sports injuries
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify how insoles affect sports activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
motion analysis data of knee
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
the height of insole
Interventions/Control_2
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy student volunteers
Key exclusion criteria
History of lower extremity injury
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Seikai |
| Middle name | |
| Last name | Toyooka |
Organization
Teikyo Univerisity
Division name
Sports Scientific Center
Zip code
1120011
Address
2-11-1 Kaga Itabashi Tokyo
TEL
0339641211
blueocean1092@hotmail.com
Public contact
Name of contact person
| 1st name | Seikai |
| Middle name | |
| Last name | Toyooka |
Organization
Teikyo University
Division name
Sports Scientific Center
Zip code
1120011
Address
2-11-1 Kaga Itabashi Tokyo
TEL
0339641211
Homepage URL
blueocean1092@hotmail.com
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo 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
Teikyo University
Address
2-11-1 Kaga Itabashi Tokyo
Tel
0339641211
blueocean1092@hotmail.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
| 2021 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
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
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052581
