UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045972 |
|---|---|
| Receipt number | R000052474 |
| Scientific Title | Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/05/16 11:42:26 |
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Basic information
Public title
Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Acronym
Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Scientific Title
Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Scientific Title:Acronym
Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the "variability" of the knee joint inversion angle during the stepping movement and the intensity of knee joint pain, knee extension muscle strength, and the severity of knee deformity in patients with knee osteoarthritis.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between the degree of deformity progression and the angle of knee inversion and the angle of lateral tilt of the lower leg when stepping movement.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Variability of knee joint inversion angle during stepping movement.
Key secondary outcomes
Intensity of knee joint pain during weight bearing
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
| 40 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient with Knee Osteoarthritis
Kellgren Lawrence grade >=2
Key exclusion criteria
1)History of surgery on ipsilateral knee
2)Systemic inflammatory arthritis (RA etc.)
3)Cognitive decline due to psychiatric disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | shigeki |
| Middle name | |
| Last name | yokoyama |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Science
Zip code
6078175
Address
34 Yamada-cho Oyake Yamashina-ku, Kyoto
TEL
0755711111
yokoyama-s@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | shigeki |
| Middle name | |
| Last name | yokoyama |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Science
Zip code
6078175
Address
34 Yamada-cho Oyake Yamashina-ku, Kyoto
TEL
0755711111
Homepage URL
yokoyama-s@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suginoshita Orthopeadics Clinic
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethical Review Board of Kyoto Tachibana University
Address
34 Yamada-cho Oyake Yamashina-ku, Kyoto
Tel
0755744186
aca-ext@tachibana-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
| 2021 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
To investigate the factors affecting knee pain in patients with knee osteoarthritis during stepping movement.
The object variables are VAS on stepping movement.
We perform multivariate analysis using basic data such as radiograph severity, motion analysis of knee and hip.
Management information
Registered date
| 2021 | Year | 11 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052474
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
