UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058751 |
|---|---|
| Receipt number | R000067177 |
| Scientific Title | Development of a method for evaluating the transverse arch of the midfoot and examination of its relationship with foot and ankle kinematics during movement |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/09 17:20:37 |
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Basic information
Public title
Development of a method for evaluating the transverse arch of the midfoot and examination of its relationship with foot and ankle kinematics during movement
Acronym
Transverse arch and foot and ankle motion trial
Scientific Title
Development of a method for evaluating the transverse arch of the midfoot and examination of its relationship with foot and ankle kinematics during movement
Scientific Title:Acronym
Transverse arch and foot and ankle motion trial
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Calculate indicators related to the transverse arch of the midfoot using magnetic resonance imaging (MRI) and verify their validity against measurements taken with a three-dimensional foot moulding device.
2. Confirm the relationship between the flexibility of the transverse arch of the midfoot and joint movement and balance ability during movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI image data of the foot, foot shape data (3D foot scanner)
Key secondary outcomes
Three-dimensional coordinate data, ground reaction force data, foot shape data (actual measurements)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
MRI imaging (number of sessions: 1, time restraint: 2.5 hours, imaging site: foot and ankle joint)
Foot morphometric evaluation
Three-dimensional movement analysis (gait and sports-related movements)
Interventions/Control_2
MRI imaging (number of sessions: 1, time restraint: 2.5 hours, imaging site: foot and ankle joint)
Foot morphometric evaluation
Three-dimensional movement analysis (gait and sports-related movements)
Interventions/Control_3
MRI imaging (number of sessions: 1, time restraint: 2.5 hours, imaging site: foot and ankle joint)
Foot morphometric evaluation
Three-dimensional movement analysis (gait and sports-related movements)
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. men and women aged 18 years and over and under 30 years at the time of obtaining consent
2. who do not have any orthopaedic disease of the lower limbs at the time of obtaining consent
3. who can give written consent to participate in this study
Key exclusion criteria
1. persons with orthopedic conditions of the lower limbs at the time of obtaining consent
2. who wear metal objects that cannot be removed
3. who are claustrophobic or resistant to enclosed spaces
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
makoto-komiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
Homepage URL
makoto-komiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Makoto Komiya
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
025-257-4455
makoto-komiya@nuhw.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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067177
