UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057462 |
|---|---|
| Receipt number | R000065656 |
| Scientific Title | The Actual Condition of Locomotive Syndrome in Manufacturing Workers and Extraction of Workplace Accident Risk Factors Related to the Severity of the Condition |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/31 15:31:58 |
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Basic information
Public title
Research study to clarify the risk of occupational accidents such as falls related to the severity of locomotive syndrome (locomo).
Acronym
Research study to clarify the risk of occupational accidents such as falls related to the severity of locomotive syndrome (locomo).
Scientific Title
The Actual Condition of Locomotive Syndrome in Manufacturing Workers and Extraction of Workplace Accident Risk Factors Related to the Severity of the Condition
Scientific Title:Acronym
The Actual Condition of Locomotive Syndrome in Manufacturing Workers and Extraction of Workplace Accident Risk Factors Related to the Severity of the Condition
Region
| Japan |
Condition
Condition
Locomotive Syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the actual status of locomotive syndrome among workers in the manufacturing industry and to identify risk factors for occupational accidents including falls related to the severity of locomotive syndrome.
Basic objectives2
Others
Basic objectives -Others
In order to achieve the aforementioned research objectives, the following points are planned to be clarified.
(1) To determine the severity of locomotion among workers in the manufacturing industry and to clarify the actual condition of locomotion.
(2) To compare the physical, mental/psychological, and social aspects of locomotion according to the severity of locomotion (normal - locomotion severity 1 - locomotion severity 2 - locomotion severity 3), and to clarify the differences between them.
(3) To extract physical, mental/psychological, and social factors related to the severity of locomo using multivariate analysis (e.g., multinomial logistic regression analysis).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of work-related injuries in subjects with locomo
The severity of locomo in subjects is determined using (1) the locomo rise test, (2) the locomo 2-step test, and (3) the locomo 25 interview, as prescribed by the Japanese Orthopaedic Association. Each subject will participate in periodic in-house health checkups for the degree of locomotion, and all of the tests from (1) to (3) will be conducted.
Key secondary outcomes
(1) Basic information
Basic information including gender, age, medical history, comorbidities, medications (e.g., antihypertensive medications, benzodiazepines), working hours, type of industry, shift work, membership in sports club, history of falls, anthropometric data (Body Mass Index (BMI), muscle mass), grip strength, standing balance ability, walking speed, and specific health checkup questionnaire The basic information including body composition data (Body Mass Index (BMI), muscle mass), grip strength, standing balance ability, walking speed, and specific health checkup questionnaires are directly measured or interviewed.
(2) Loco-mo test
The following tests are used to test the degree of locomotion: (1) Loco-mo rise test, (2) Loco-mo 2-step test, and (3) Loco-mo 25 questionnaire, as specified by the Japanese Orthopaedic Association.
The criteria for determining the degree of locomo in this study is that if any of the aforementioned tests (1) Rise test, (2) 2-step test, and (3) LOKOMO 25 are applicable, the patient is judged to have locomo.
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
| 66 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who will work in the manufacturing industry between the date of approval by the head of the research institution and March 31, 2028
2) Subjects who are between 18 and 66 years of age at the time of obtaining consent
3) Subjects who can obtain written consent from the individual for free and voluntary research participation
Key exclusion criteria
(1) Persons with severe functional impairment of motor units and difficulty in performing tests to classify the severity of locomotion
(2) Persons with strong psychiatric symptoms and significant cognitive dysfunction
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita University
Division name
Graduate School of Medicine
Zip code
010-8543
Address
Hondo1-1-1, Akita city
TEL
0188846556
kume.yuu@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita university
Division name
Health Sciences
Zip code
010-8543
Address
Hondo 1-1-1, Akita city
TEL
0188846556
Homepage URL
kume.yuu@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Yu Kume
Funding Source
Organization
Akita 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
Akita University
Address
Hondo 1-1-1, Akita city
Tel
0188846556
kume.yuu@hs.akita-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
| 2025 | Year | 04 | Month | 01 | 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 | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the Locomo Degree Test (Japanese Orthopaedic Association) is administered to workers in the manufacturing industry to evaluate the state of locomotive syndrome. The relationship between the severity of locomotive syndrome and basic information including age, gender, industry, history of falls, nighttime sleeping habits, work-life balance, etc. will then be verified. In addition, multivariate analysis will be conducted according to the severity of locomotive syndrome (normal, locomotion level 1, locomotion level 2, and locomotion level 3), and physical, psycho-psychological, and social factors related to locomotive syndrome will be extracted.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065656
