UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063385 |
|---|---|
| Receipt number | R000072553 |
| Scientific Title | Effects of Toe Flexor Strength Training on Intrinsic Foot Muscle Volume and Activity |
| Date of disclosure of the study information | 2026/10/23 |
| Last modified on | 2026/10/23 11:57:53 |
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Basic information
Public title
Effects of Toe Strength Training on Foot Muscle Size and Activity
Acronym
Toe Flexor Training Study
Scientific Title
Effects of Toe Flexor Strength Training on Intrinsic Foot Muscle Volume and Activity
Scientific Title:Acronym
Toe Flexor Strength Training Study
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of toe flexor strength training on the morphology and activity of individual plantar intrinsic foot muscles. In addition, this study aims to examine whether the activity of the plantar intrinsic foot muscles differs according to the positions of the interphalangeal and metatarsophalangeal joints during toe flexion force production, and whether training-induced changes in foot muscle morphology, toe flexor strength, foot structure, and balance performance differ according to the toe movement used during training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Muscle volume: The anatomical cross-sectional area and muscle volume of individual intrinsic and extrisnic foot muscles will be assessed using T1-weighted magnetic resonance images before and after the 12-week training intervention.
2. Activity of the plantar intrinsic foot muscles: Muscle activity of individual plantar intrinsic foot muscles will be assessed using functional magnetic resonance imaging based on exercise-induced changes in T2 values following a toe-flexion fatigue task. Measurements will be performed before and after the 12-week training intervention.
Key secondary outcomes
1. Toe flexor strength: Toe flexor strength with gripping action and with pushing action will be assessed.
2. Foot structure: Foot dimensions, including foot length, height, width, circumference, volume, hallux and fifth-toe angles, and foot alignment assessed using the Foot Posture Index-6 will be evaluated.
3. Balance performance: Static balance performance will be assessed using postural-sway measures during standing tasks, and dynamic balance performance will be assessed using the Star Excursion Balance Test.
These outcomes will be assessed before and after the 12-week training intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants perform toe flexor strength training using a toe gripping action twice weekly for 12 weeks. Each training session consists of five sets of 10 repetitions of 5-s toe flexion contractions followed by 5-s rest periods. Training intensity is prescribed relative to maximal toe flexor strength and progressively increased throughout the intervention period.
Interventions/Control_2
Participants perform toe flexor strength training using a toe pushing action twice weekly for 12 weeks. Each training session consists of five sets of 10 repetitions of 5-s toe flexion contractions followed by 5-s rest periods. Training intensity is prescribed relative to maximal toe flexor strength and progressively increased throughout the intervention period.
Interventions/Control_3
Participants do not perform toe flexor strength training during the 12-week intervention period and are instructed to maintain their usual daily activities.
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
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy young adult men and women aged 18 years or older and younger than 39 years.
2. Individuals who receive an explanation of the study and provide informed consent to participate.
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded:
1. Individuals with symptoms suggestive of a serious physical or mental disorder or injury at the time of enrollment.
2. Individuals who are unable to walk independently.
3. Individuals who are or may be pregnant.
4. Individuals who, after receiving an explanation of the study, are unable to provide consent to participate.
5. Individuals with cardiac or cardiovascular disease, implanted ferromagnetic materials, or claustrophobia that may increase the risk associated with magnetic resonance imaging.
6. Individuals who habitually perform training targeting the foot or lower-leg muscles.
7. Individuals with orthopedic disorders of the foot or ankle.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Isaka |
Organization
Ritsumeikan University
Division name
Colleage of sport and health science
Zip code
525-8577
Address
1-1-1, Nogihigashi, Kusatsu, Shiga, JAPAN
TEL
077-561-2791
isaka@se.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kusagawa |
Organization
Ritsumeikan university
Division name
Colleage of sport and health science
Zip code
525-8577
Address
1-1-1, Nogihigashi, Kusatsu, Shiga, JAPAN
TEL
077-599-4336
Homepage URL
y-kusa@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
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
Ritsumeikan University IRB
Address
1-1-1, Nogihigashi, Kusatsu, Shiga, JAPAN
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2026 | Year | 10 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072553
