UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042719 |
|---|---|
| Receipt number | R000048759 |
| Scientific Title | Development of a simple tool for flatfoot assessment |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2020/12/10 18:16:35 |
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Basic information
Public title
Development of a simple tool for flatfoot assessment
Acronym
Development of a simple tool for flatfoot assessment
Scientific Title
Development of a simple tool for flatfoot assessment
Scientific Title:Acronym
Development of a simple tool for flatfoot assessment
Region
| Japan |
Condition
Condition
flat foot
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the usefulness of a simple tool developed to clearly and easily diagnose flat feet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subject will take a CT of the foot and then measure the distance between the scaphoid base and plantar skin in the center of the scaphoid in a sagittal section. They will then evaluate the arch height with the Simplified Flatfoot Assessment Tool and analyze whether there is an association between the two assessment methods.
Compare the results of the Quick Assessment Tool with the image evaluation and evaluate the validity of the Quick Assessment Tool.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with CT scan of the foot
Key exclusion criteria
1) A history of lower extremity surgery 2) Any symptoms in the lower extremities
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seikai |
| Middle name | |
| Last name | Toyooka |
Organization
Teikyo University
Division name
Department of Orthopaedic Surgery
Zip code
1738606
Address
Kaga Itabashi Tokyo
TEL
03-3964-1211
blueocean1092@hotmail.com
Public contact
Name of contact person
| 1st name | Seikai |
| Middle name | |
| Last name | Toyooka |
Organization
Teikyo University
Division name
Department of Orthopaedic Surgery
Zip code
1738606
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
| 2020 | Year | 12 | Month | 10 | 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
35
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 | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subject will take a CT of the foot and then measure the distance between the scaphoid base and plantar skin in the center of the scaphoid in a sagittal section. They will then evaluate the arch height with a simple flatfoot assessment tool and analyze whether there is an association between the two assessment methods.
Management information
Registered date
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048759
