UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057615 |
|---|---|
| Receipt number | R000065831 |
| Scientific Title | Validity and Reliability of a Marker Set for Measuring Navicular Displacement and Rearfoot Angle Inside Shoes During Walking |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 11:43:04 |
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Basic information
Public title
Validity and Reliability of a Marker Set for Measuring Navicular Displacement and Rearfoot Angle Inside Shoes During Walking
Acronym
Validity and Reliability of a Marker Set for Measuring Navicular Displacement and Rearfoot Angle Inside Shoes During Walking
Scientific Title
Validity and Reliability of a Marker Set for Measuring Navicular Displacement and Rearfoot Angle Inside Shoes During Walking
Scientific Title:Acronym
Validity and Reliability of a Marker Set for Measuring Navicular Displacement and Rearfoot Angle Inside Shoes During Walking
Region
| Japan |
Condition
Condition
Healthy Individuals with and without flat feet.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing novel reflective markers capable of reliably and validly analyzing foot motion during functional tasks while wearing foot orthoses such as insoles and shoes applied for foot problems can contribute to the evaluation of the effectiveness of foot orthoses and the development of new foot orthoses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lower limb joint angles and alignment changes within the foot (navicular displacement and rearfoot displacement) during walking and running
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Insole insertion into shoes during walking and running
Interventions/Control_2
Walking and running at different speeds
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals with and without flat feet
Key exclusion criteria
History of foot or ankle surgery.
Foot deformity or leg length discrepancy exceeding 1 cm.
Musculoskeletal disorders, neurological conditions, or peripheral neuropathy that could affect walking ability.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | BONGKOCH |
| Middle name | |
| Last name | PRAEWPIPAT |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Sciences
Zip code
950-3198
Address
1398 Shimami Kitaku Niigata
TEL
0252574456
HWD23021@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | MASAYOSHI |
| Middle name | |
| Last name | KUBO |
Organization
Niigata University of Health and Welfare
Division name
Graduate school of Health and Welfare Sciences
Zip code
950-3198
Address
1398 Shimami Kitaku Niigata
TEL
0252574456
Homepage URL
kubo@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami Kitaku Niigata
Tel
0252574416
rinri@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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 | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065831
