UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057517 |
|---|---|
| Receipt number | R000065713 |
| Scientific Title | A Study on the Effects of Footwear on Physical Function and Disease Structure |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2025/10/08 20:55:23 |
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Basic information
Public title
A Study on the Effects of Footwear on Physical Function and Disease Structure
Acronym
Effects of Footwear on Physical Function
Scientific Title
A Study on the Effects of Footwear on Physical Function and Disease Structure
Scientific Title:Acronym
Effects of Footwear on Physical Function
Region
| Japan |
Condition
Condition
Lower Limb Joint Disorders, Diabetes Mellitus, Hypertension
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the following among ambulatory individuals:
(1) the effects of wearing functional footwear on physical functions such as gait performance,
(2) the incidence of newly developed conditions such as knee osteoarthritis, and
(3) the impact of foot condition on activity levels.
Additionally, in order to assess potential improvement effects, a longitudinal follow-up will be conducted on anatomical features of the foot, lower limb muscle strength, and body composition metrics such as waist circumference and body fat percentage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the improvement in physical functions, particularly focusing on toe-ground contact and lower limb muscle strength.
Key secondary outcomes
(1) To evaluate the effects of footwear on gait function by comparing gait analysis and foot morphology assessments under both footwear-wearing and non-wearing conditions in the same participants.
(2) To compare the incidence of newly developed joint disorders and other diseases using medical insurance claims data, adjusting for underlying health conditions.
(3) To compare the rates of certification for long-term care needs and the incidence of dementia between the study group and a control group using data from the long-term care insurance system.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Wearing functional footwear
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who are capable of independent ambulation.
Key exclusion criteria
Individuals who are unable to walk independently
Individuals who are unable to attend the measurement sessions
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Department of Clinical Engineering, Faculty of Human Care of Makuhari
Zip code
261-0021
Address
1-1 Hibino Mihama, Chiba city, Chiba, Japan
TEL
043-273-1111
kazuhiko.yamahsita@tohto.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Department of Clinical Engineering, Faculty of Human Care of Makuhari
Zip code
261-0021
Address
1-1 Hibino Mihama, Chiba city, Chiba, Japan
TEL
043-273-1111
Homepage URL
kazuhiko.yamashita@tohto.ac.jp
Sponsor or person
Institute
Tohto University
Institute
Department
Personal name
Funding Source
Organization
Tohto 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
the Research Ethics Committee of Tohto University
Address
1-1 Hibino Mihama, Chiba city, Chiba, Japan
Tel
043-273-1111
rinri@tohto.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 | 04 | Month | 04 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065713
