UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048564 |
|---|---|
| Receipt number | R000055338 |
| Scientific Title | Investigation of knee gliding motion on cartilage degeneration: Cohort study |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2026/02/04 09:19:00 |
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Basic information
Public title
Investigation of knee gliding motion on cartilage degeneration: Cohort study
Acronym
Investigation of knee gliding motion on cartilage degeneration
Scientific Title
Investigation of knee gliding motion on cartilage degeneration: Cohort study
Scientific Title:Acronym
Investigation of knee gliding motion on cartilage degeneration
Region
| Japan |
Condition
Condition
older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine longitudinally the relationship between pattern of intra-joint motion in knee during gait and the cartilage degeneration.
Basic objectives2
Others
Basic objectives -Others
To examine longitudinally the relationship between pattern of intra-joint motion in knee during gait and the cartilage degeneration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cartilage thickness
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling elderly
Independent ADL
Key exclusion criteria
history of knee surgery
Musculoskeletal disease
Impaired cognitive function
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Ogaya |
Organization
Saitama Prefectural University
Division name
Division of Physical Therapy, School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama
TEL
048-971-0500
ogaya-shinya@spu.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Ogaya |
Organization
Saitama Prefectural University
Division name
Division of Physical Therapy, School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama
TEL
048-971-0500
Homepage URL
ogaya-shinya@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University Research ethics committee
Address
820 Sannomiya, Koshigaya-shi, Saitama
Tel
048-971-0500
ogaya-shinya@spu.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
| 2022 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/ptcse/32/1/32_32-52/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/ptcse/32/1/32_32-52/_article/-char/ja
Number of participants that the trial has enrolled
64
Results
Neither the internal/external rotation angles nor the rotational range of motion during straight or curved walking showed a significant association with the development of knee pain. In contrast, the knee valgus angle during straight walking was significantly associated with pain onset (odds ratio = 0.68).This study did not find evidence suggesting that knee rotational motion during gait is involved in the development of knee pain.
Results date posted
| 2026 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community-dwelling elderly
Participant flow
Participants were recruited through advertisements in a local community newspaper, and eligibility criteria were confirmed in person through face-to-face screening.
Adverse events
no
Outcome measures
Knee joint angle during gait, ICOAP, VAS, KOOS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 04 | Day |
Other
Other related information
We observe knee cartilage thickness, osteophytes, edema, pain, stiffness, tenderness, crepitus, and palpating warmth.
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055338
