UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056845 |
|---|---|
| Receipt number | R000064968 |
| Scientific Title | Effect of wearing foot orthoses on physical movement |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/02/06 13:44:23 |
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Basic information
Public title
Efficacy test of the foot orthosis
Acronym
Efficacy test of the foot orthosis
Scientific Title
Effect of wearing foot orthoses on physical movement
Scientific Title:Acronym
Efficacy test of the foot orthosis
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects related to the wearing of plantar orthoses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data of Movement
Key secondary outcomes
Myofascial and Muscle Data
Foot shape data
Activity
Questionnaire items
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear plantar orthotic for 2wks->Wash Out->Without wearing plantar orthotic for 2wks
Interventions/Control_2
Without wearing plantar orthotic for 2wks->Wash Out->Wear plantar orthotic for 2wks
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women between the ages of 20 and 59
2.Those whose usual shoe size is 29 cm or smaller
Key exclusion criteria
1. Those with pain or injury that affects walking
2. Those who have had surgery in the past and have difficulty walking normally
3. Those who have dislocated their shoulder in the past
4. Those who have neck or shoulder pain that makes it difficult to take this measurement
5. Those who are pregnant or may become pregnant
6. Those who are otherwise deemed inappropriate by the principal investigator or researcher in charge of the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Yamashiro |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
yamashiro.yukari@kao.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ueda |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
Homepage URL
ueda.tomoya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2025 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
67
Results
Similar to prior studies, wearing the half-type insoles was found to affect certain gait metrics. Some immediate effects (particularly pelvic sagittal plane and trunk sagittal plane angles) suggested a
potential correlation with the subjective assessment of "easier walking." Wearing the developed product (for two weeks) resulted in confirmed perceived effectiveness through questionnaires and OA assessments.
Results date posted
| 2026 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Men and women between the ages of 20 and 59
2. Those whose usual shoe size is 29 cm or smaller
Participant flow
Participate in screening test
Participate in main trial 1 (assigned to either control group or insole wear group)
Washout period
Participate in main trial 2 (cross-over between groups)
Trial completion
Adverse events
One individual experienced foot pain while wearing insoles, but subsequently recovered without requiring medical treatment.
Outcome measures
-Data of Movement
-Questionnaire items
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 05 | 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 | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064968
