UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061845 |
|---|---|
| Receipt number | R000070765 |
| Scientific Title | Does Floating Toe Affect Static and Dynamic Postural Stability, Gait Initiation, and Jump Performance? |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/09 14:17:33 |
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Basic information
Public title
Study on the Effects of Floating Toe on Posture, Gait, and Jump Performance
Acronym
Floating Toe Study
Scientific Title
Does Floating Toe Affect Static and Dynamic Postural Stability, Gait Initiation, and Jump Performance?
Scientific Title:Acronym
Floating Toe Functional Assessment
Region
| Japan |
Condition
Condition
Floating Toe
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of floating toe on static and dynamic postural stability, gait initiation, stepping performance, and jumping performance in healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indices of static and dynamic postural stability (center of pressure sway and plantar pressure distribution measures)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants without floating toe will be assessed under a normal condition and a simulated floating toe condition using research insoles or research shoes. Static and dynamic postural stability, plantar pressure distribution, gait initiation, stepping performance, and jumping performance will be measured. The intervention will be performed only on the day of assessment, and the use of the research insoles or shoes will be limited to the measurement tasks. Each detailed experiment will take approximately 60-90 minutes and will be conducted up to two times per participant.
Interventions/Control_2
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy men and women aged 18 to 30 years.
2.Individuals who understand the explanation of the study and provide written informed consent.
3.University students, technical college students, athletes, or adults participating in community sports clubs or similar organizations.
Key exclusion criteria
1.Individuals with acute lower limb injury or worsening lower limb pain.
2.Individuals who have recently undergone lower limb surgery.
3.Individuals with neurological disorders or severe cardiovascular disease.
4.Individuals who are pregnant or judged to require special safety consideration.
5.Individuals who are in poor physical condition on the day of measurement.
6.Individuals judged by the principal investigator to be inappropriate for participation in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
950-3198
Address
1398,Shimami-cho,Kita-ku,Niigata,Japan
TEL
025-257-4435
tos-sato@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
950-3198
Address
1398,Shimami-cho,Kita-ku,Niigata,Japan
TEL
025-257-4435
Homepage URL
tos-sato@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
Other
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-cho,Kita-ku,Niigata,Japan
Tel
025-257-4435
tos-sato@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
| 2026 | Year | 06 | Month | 10 | 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 | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | 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 | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070765
