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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000046071
Receipt No. 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

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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
Email 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
Email blueocean1092@hotmail.com

Sponsor
Institute Teikyo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052581

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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