UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058257 |
|---|---|
| Receipt number | R000066594 |
| Scientific Title | Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/06/23 18:58:09 |
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Basic information
Public title
Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot
Acronym
Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot
Scientific Title
Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot
Scientific Title:Acronym
Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot
Region
| Japan |
Condition
Condition
flat foot
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of two different 3D-printed insole materials on medial longitudinal arch support and hindfoot alignment in adults with flexible flatfoot. We will examine how varying speeds during walking and running tasks influence the therapeutic efficacy of these insoles. The research aims to explore the effectiveness of 3D printing materials in personalized flatfoot management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower Limb and Foot Joint Motion During Gait
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Insoles Made From a Single Material
Interventions/Control_2
Insoles made from different materials
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with a navicular drop exceeding 10 mm and a Foot Posture Index score of 6 or higher
Key exclusion criteria
1. History of foot or ankle surgery.
2. Foot deformity or leg length discrepancy exceeding 1 cm.
3. Presence of musculoskeletal disorders, neurological conditions, or peripheral neuropathy that may affect gait ability.
4. Experience with customized insoles within the past year.
Target sample size
32
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
Zip code
9503198
Address
1398 Shimami Kitaku Niigata
TEL
0252574455
hwd23021@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masayosih |
| Middle name | |
| Last name | Kubo |
Organization
Niigata University of Health and Welfare
Division name
Graduate School
Zip code
9503198
Address
1398 Shimami Kitaku Niigata
TEL
0252574455
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
0252574455
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 | 07 | Month | 22 | 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 | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066594
