UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057770 |
|---|---|
| Receipt number | R000066021 |
| Scientific Title | Effects of different component combinations on standing, walking and the foot when wearing shoes |
| Date of disclosure of the study information | 2025/05/03 |
| Last modified on | 2025/05/03 17:52:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of different component combinations on standing, walking and the foot when wearing shoes
Acronym
Effects of different component combinations on standing, walking and the foot when wearing shoes
Scientific Title
Effects of different component combinations on standing, walking and the foot when wearing shoes
Scientific Title:Acronym
Effects of different component combinations on standing, walking and the foot when wearing shoes
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the effects of the combination of components that make up a shoe on walking movements and the foot, and to identify the optimal combination of shoe components for each application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Experimental shoes are set up using a combination of shoe components, and the effects on walking movements and the feet are measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of experimental shoes while standing and walking.
Interventions/Control_2
Use of regular shoes while standing and walking
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
Healthy individuals
Key exclusion criteria
Excluding those with foot disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Abe |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata
TEL
025-257-4525
kao-abe@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Abe |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata
TEL
025-257-4525
Homepage URL
kao-abe@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
Profit organization
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-city, Niigata
Tel
025-257-4525
kao-abe@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
| 2025 | Year | 05 | Month | 03 | 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
| 2025 | Year | 05 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066021
