UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061377 |
|---|---|
| Receipt number | R000070226 |
| Scientific Title | An exploratory study of the effects of a foot bone-strengthening program on bone-related indicators, toe muscle strength, foot function, physical function, and health-related indicators, and the associations among these measures in male and female participants |
| Date of disclosure of the study information | 2026/04/26 |
| Last modified on | 2026/04/26 14:29:32 |
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Basic information
Public title
Exploratory study on the effects of a foot bone-strengthening program on bone-related, foot function, and health-related indicators
Acronym
Foot Bone Strengthening Study
Scientific Title
An exploratory study of the effects of a foot bone-strengthening program on bone-related indicators, toe muscle strength, foot function, physical function, and health-related indicators, and the associations among these measures in male and female participants
Scientific Title:Acronym
BONE Program Study
Region
| Japan |
Condition
Condition
Male and female athletes and healthy individuals with, or at risk of, reduced bone-related indicators, impaired foot function, reduced toe muscle strength, impaired posture and balance function, or other physical and health-related concerns
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily examine the effects of the BONE program, a foot bone-strengthening program focusing on the skeletal structure of the foot, on bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, lifestyle factors, psychological and behavioral indicators, and health-related indicators in male and female participants. This study will also examine interrelationships among bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, physical function, body composition, vascular indicators, lifestyle factors, and subjective assessments, and will comprehensively evaluate the effectiveness, safety, feasibility, and applicability of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are changes before and after the BONE program in bone-related indicators, foot function, toe muscle strength, plantar pressure distribution, posture and balance function, and health-related indicators. These may include speed of sound at the calcaneus, bone area ratio, bone mineral density-related indicators, toe muscle strength, foot contact area, plantar pressure distribution in the forefoot and rearfoot, center-of-gravity sway distance, sway area, mean sway velocity, physical function, body composition, vascular indicators, and subjective health status.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants who provide informed consent will be randomly allocated to either the intervention group or the control group. Participants in the intervention group will undergo foot-related, bone-related, and physical function improvement programs, including the BONE program, in addition to their usual club activities, usual practice, usual warm-up, or usual activity. The programs aim to provide low-intensity mechanical stimulation to the foot and lower limbs, enhance foot arch function, utilize the lever function of the foot bones, improve mobility of the foot bones, improve toe muscle strength and foot function, enhance posture and balance function, and improve physical function and health-related indicators. The programs may include foot stimulation using a wooden ball or similar tool, toe exercises, foot and lower-limb exercises, weight-bearing exercises, balance exercises, stretching, education, self-monitoring, and feedback. The intervention will generally be performed several times per week for approximately 15 minutes per session over approximately 1 to 3 months. The frequency, duration per session, intervention period, and method may be adjusted according to the study protocol, considering participant affiliation, training environment, feasibility, and safety.
Interventions/Control_2
Participants who provide informed consent and are randomly allocated to the control group will continue their usual club activities, usual practice, usual warm-up, or usual support without the additional BONE program or foot-related, bone-related, and physical function improvement programs. The control group will undergo assessments during the same period as the intervention group, including bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, health-related indicators, and questionnaire-based measures.
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
| 8 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elementary school to high school-aged individuals.
Male or female participants.
Individuals who are able to participate in sports activities, physical activities, or assessments of health and physical function.
Individuals who are able to participate in the BONE program, foot bone-strengthening program, usual activity, measurements, surveys, or assessments.
Individuals who are able to undergo assessments of bone-related indicators, foot function, toe muscle strength, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, health-related indicators, lifestyle factors, or questionnaire-based measures.
Individuals from whom consent for study participation can be obtained from both the participant and a parent or guardian.
Key exclusion criteria
Individuals judged by the principal investigator or co-investigators to be unsuitable for participation in this study.
Individuals who are judged to have difficulty participating in the BONE program, foot bone-strengthening program, exercise, usual activity, measurements, surveys, or assessments for safety reasons.
Individuals judged to have difficulty participating in the intervention, measurements, surveys, or assessments due to conditions related to the foot, lower limbs, bones, muscles, joints, nervous system, cardiovascular system, or other health conditions.
Individuals from whom consent for study participation cannot be obtained from the participant or a parent or guardian.
Individuals otherwise judged to be unsuitable for participation according to the study protocol.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashihiroshima-shi, Hiroshima, Japan
TEL
082-424-6844
shihok@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashihiroshima-shi, Hiroshima, Japan
TEL
082-424-6844
Homepage URL
shihok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University
Address
1-1-1 Kagamiyama, Higashihiroshima-shi, Hiroshima, Japan
Tel
082-424-6844
shihok@hiroshima-u.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 | 04 | Month | 26 | 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
| 2026 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 26 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070226
