UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058178 |
|---|---|
| Receipt number | R000066506 |
| Scientific Title | Association between Foot Morphology, Pain, Locomotive Syndrome, and Presenteeism in Adult Women |
| Date of disclosure of the study information | 2025/06/14 |
| Last modified on | 2025/09/02 14:39:55 |
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Basic information
Public title
Association between Foot Morphology, Pain, Locomotive Syndrome, and Presenteeism in Adult Women
Acronym
Association between Foot Morphology, Pain, Locomotive Syndrome, and Presenteeism in Adult Women
Scientific Title
Association between Foot Morphology, Pain, Locomotive Syndrome, and Presenteeism in Adult Women
Scientific Title:Acronym
Association between Foot Morphology, Pain, Locomotive Syndrome, and Presenteeism in Adult Women
Region
| Japan |
Condition
Condition
Healthy women including pregnant women
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how foot morphology and foot pain are associated with locomotive syndrome and presenteeism among adult women with childbirth experience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
presenteeism
Key secondary outcomes
mental health, foot morphology, foot pain ,and locomotive syndrome
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women
Key exclusion criteria
Implanted medical devices (e.g., pacemaker)
Inability to walk independently
Medical conditions that preclude safe testing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kio University
Division name
Depertment of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
TEL
0745-54-1601
d.matsumoto@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kio University
Division name
Depertment of Health Sciences
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
TEL
0745541601
Homepage URL
d.matsumoto@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Daisuke Matsumoto
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan.
Tel
0745541601
d.matsumoto@kio.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
奈良県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 14 | 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 | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey
Basic information: age, height, weight, birth history, time since birth, employment status
Foot pain: pain location, pain level (Numerical Rating Scale), shoe-related (3 days a week, heels 5cm or more)
Low back pain: Oswestry Disability Index
Physical activity: IPAQ-SF
Presenteeism: Single-Item Presenteeism Question (SPQ)
Measurements
Foot shape: foot length, arch height (photometric method), hallux valgus, flat feet
Physical function: toe grip strength, locomotive syndrome: standing up test, 2-step test
Body composition
Management information
Registered date
| 2025 | Year | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066506
