UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060918 |
|---|---|
| Receipt number | R000069145 |
| Scientific Title | Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 11:37:43 |
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Basic information
Public title
Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis
Acronym
Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis
Scientific Title
Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis
Scientific Title:Acronym
Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimates indicate that 253 million patients in Japan are diagnosed with knee osteoarthritis based on plain radiographs Among musculoskeletal disorders osteoarthritis including knee osteoarthritis is the leading cause of disability requiring long term care certification Knee orthotic therapy for patients with knee osteoarthritis is established as a common treatment method but research demonstrating scientific evidence is insufficient and its general applicability is low This study aims to contribute to measures concerning orthotic therapy for knee osteoarthritis by measuring and understanding the effects of knee orthoses worn by patients with knee osteoarthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement items include joint angles and moments obtained using a motion analysis device. Secondary investigations include the subjects gender age weight height diagnosis imaging findings knee joint function degree of independence in basic motor skills degree of independence in ADL motor skills knee joint pathology medial type lateral type patellar type total type knee disease stage time since onset knee disease severity KL classification Grade I IV pain intensity NRS comfort of orthotic devices NRS walking speed comfortable pace 6 minute walk distance TUG chief complaint presence of other therapies eg medication and past medical history including surgical history
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Knee orthosis
Interventions/Control_2
Without knee orthosis
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis hospitalized or receiving outpatient care at research facilities, based on an estimated number derived from prior studies
Key exclusion criteria
Patients exhibiting functional impairment or pain that impedes measurement
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yamamoto |
Organization
Fukuoka Tenjin Medical Rehabilitation Academy
Division name
Department of Physical Therapy
Zip code
810-0004
Address
4-3-7 Watanabedori, Chuo-ku, Fukuoka-shi, Fukuoka
TEL
0927387823
h.yamamoto.28.0321@gmail.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yamamoto |
Organization
Fukuoka Tenjin Medical Rehabilitation Academy
Division name
Department of Physical Therapy
Zip code
810-0004
Address
4-3-7 Watanabedori, Chuo-ku, Fukuoka-shi, Fukuoka
TEL
0927387823
Homepage URL
h.yamamoto.28.0321@gmail.com
Sponsor or person
Institute
Fukuoka Tenjin Medical Rehabilitation Academy
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Tenjin Medical Rehabilitation Academy
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
Fukuoka Tenjin Medical Rehabilitation Academy
Address
4-3-7 Watanabedori, Chuo-ku, Fukuoka-shi, Fukuoka
Tel
0927387823
h.yamamoto.28.0321@gmail.com
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
| 2026 | Year | 03 | Month | 13 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069145
