UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054145 |
|---|---|
| Receipt number | R000061829 |
| Scientific Title | Comparison of kinematics and kinetics of the leading and trailing leg in obstacle-straddling movements before and after total knee arthroplasty. |
| Date of disclosure of the study information | 2024/04/14 |
| Last modified on | 2024/04/14 01:42:09 |
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Basic information
Public title
Comparison of kinematics and kinetics of the leading and trailing leg in obstacle-straddling movements before and after total knee arthroplasty.
Acronym
Motion Analysis of Leading and Trailing Legs in Obstacle-Straddling Motion Before and After Total Knee Arthroplasty
Scientific Title
Comparison of kinematics and kinetics of the leading and trailing leg in obstacle-straddling movements before and after total knee arthroplasty.
Scientific Title:Acronym
Motion Analysis of Leading and Trailing Legs in Obstacle-Straddling Motion Before and After Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Total Knee Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the kinematic and kinetic differences between the anterior and posterior legs in straddling motion after total knee arthroplasty.
Basic objectives2
Others
Basic objectives -Others
Motion analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Results of three-dimensional motion analysis during straddle motion before and after total knee arthroplasty
Key secondary outcomes
One leg standing time,Fear of knee flexion (VAS),Pain when walking(VAS),Knee joint extensor strength,Results of 3D motion analysis,Knee joint flexion angle
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The robot performs an obstacle-straddling motion from a stationary standing position and records it on video.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with osteoarthritis of the knee, radiologically diagnosed as grade 3 and/or 4 according to Kellgren-Lawrence criteria, and scheduled to undergo TKA.
The participants must have obtained written consent to participate in this study.
Key exclusion criteria
Those with uncontrolled systemic diseases or pre-existing neurological or other orthopedic conditions other than osteoarthritis of the knee that affect the ability to walk.
Those who have difficulty walking alone for more than 10 meters.
Those with a score of less than 20 on the Hasegawa Dementia Scale (hereinafter referred to as HDS-R) at the time of admission.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ehime Juzen Medical College Hospital
Division name
Department of Rehabilitation
Zip code
7910385
Address
561 Minamikata, Toon City, Ehime Prefecture
TEL
08029820507
massan_arazin@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ehime Juzen Medical College Hospital
Division name
Department of Rehabilitation
Zip code
7910385
Address
561 Minamikata, Toon City, Ehime Prefecture
TEL
0899665011
Homepage URL
massan_arazin@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Prefectural Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Prefectural Hiroshima 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
Ehime Juzen Medical College Hospital
Address
561 Minamikata, Toon City, Ehime Prefecture
Tel
08029820507
massan_arazin@yahoo.co.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
| 2024 | Year | 04 | Month | 14 | 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
| 2024 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061829
| 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 |
