UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059570 |
|---|---|
| Receipt number | R000068135 |
| Scientific Title | Development and reliability/validity verification of Japanese version of The Osteoarthritis Knowledge Scale (OAKS-J) and KOOS-12/HOOS-12 (KOOS-12J/HOOS-12J) |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/28 17:24:41 |
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Basic information
Public title
Development and validation of questionnaires for osteoarthritis knowledge and symptom evaluation (OAKS-J, KOOS-12J, HOOS-12J)
Acronym
Development and validation of osteoarthritis questionnaires
Scientific Title
Development and reliability/validity verification of Japanese version of The Osteoarthritis Knowledge Scale (OAKS-J) and KOOS-12/HOOS-12 (KOOS-12J/HOOS-12J)
Scientific Title:Acronym
Development and validation of OAKS-J, KOOS-12J, and HOOS-12J
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee and hip
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To translate and culturally adapt the Osteoarthritis Knowledge Scale (OAKS) into Japanese and verify its reliability and validity in Japanese people.
2. To verify the reliability and validity of the shortened versions of the Knee Injury and Osteoarthritis Outcome Score (KOOS-12J) and Hip Disability and Osteoarthritis Outcome Score (HOOS-12J) in Japanese people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Osteoarthritis Knowledge Scale
Key secondary outcomes
The 12-item short forms of the Knee injury and Osteoarthritis Outcome Score (KOOS)/Hip disability and Osteoarthritis Outcome Score (HOOS)
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those aged 45 or over who have been diagnosed with osteoarthritis by a doctor, or who meet the diagnostic criteria for osteoarthritis in the UK NICE guidelines
Key exclusion criteria
Those with problems that affect lower limb function more severely than knee or hip pain (e.g., peripheral neuropathy, diabetic lesions, Parkinson's disease, etc.)
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio Univeristy
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
d.uritani@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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 | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study using questionnaires
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068135
