UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032761 |
|---|---|
| Receipt number | R000037374 |
| Scientific Title | The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2026/06/03 16:10:57 |
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Basic information
Public title
The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait
Acronym
The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait
Scientific Title
The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait
Scientific Title:Acronym
The effect of intrinsic foot muscle training on medial longitudinal arch dynamics during gait
Region
| Japan |
Condition
Condition
Flat Foot
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of intrinsic foot muscle training on medial longitudinal arch dynamics
during gait.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medial longitudinal arch dynamics
during gait assessed by the three dimensional motion analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intrinsic foot muscle training
Interventions/Control_2
no treatment
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
Flat foot
Key exclusion criteria
pain, neurologic disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan
TEL
0848-60-1225
k-okamura@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Okamura |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan
TEL
0848-60-1225
Homepage URL
k-okamura@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
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
Ethics Committee of the Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-shi
Tel
0848-60-1120
k-okamura@pu-hiroshima.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
| 2018 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0966636219306794?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0966636219306794?via%3Dihub
Number of participants that the trial has enrolled
20
Results
The main finding of this study was that an 8-week intrinsic foot muscles exercise program shortened the time during which the medial longitudinal arch height reached its minimum value.
Results date posted
| 2026 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy university student
Participant flow
We contacted a total of 173 individuals to inform them about this study, and excluded 153 individuals because they had an FPI-6 score<6 points (149) or did not provide informed consent (4). We then allocated the remaining 20 participants equally to the exercise or control groups.
Adverse events
None
Outcome measures
Medial longitudinal arch dynamics during gait assessed by the three dimensional motion analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2023 | 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
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037374
