UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020036 |
|---|---|
| Receipt number | R000020545 |
| Scientific Title | Relationships between mobility and angular velocity of knee extension in patients with total knee arthroplasty |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2020/07/08 19:58:15 |
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Basic information
Public title
Relationships between mobility and angular velocity of knee extension in patients with total knee arthroplasty
Acronym
Relationships between mobility and angular velocity of knee extension in patients with total knee arthroplasty
Scientific Title
Relationships between mobility and angular velocity of knee extension in patients with total knee arthroplasty
Scientific Title:Acronym
Relationships between mobility and angular velocity of knee extension in patients with total knee arthroplasty
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between angular velocity of knee extension and mobility in TKA patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
angular velocity of knee extension
gait speed
Key secondary outcomes
muscle strength of knee extension
range of motion of knee extension
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who had total knee arthroplasty
Key exclusion criteria
patients with severe dementia
patients with severe neuromuscular disease
patients undergoing revision TKA
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
iwata@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
Homepage URL
iwata@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Committee on Research Ethics the Graduate School of Comprehensive Rehabilitation Osaka Prefecture University
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
Tel
072-950-2111
iwata@rehab.osakafu-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
「大阪府立急性期・総合医療センター（大阪府）」Osaka General Medical Center
「大阪労災病院（大阪府）」Osaka Rousai Hospital
「協和会病院（大阪府）」Kyowakai Hospital
「大阪南医療センター（大阪府）」Osaka Minami Medical Center
「大阪府済生会吹田病院（大阪府）」Saiseikai Suita Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 02 | 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
281
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the importance of the knee angular velocity in the mobility of TKA patients by a prospective cohort study.
Management information
Registered date
| 2015 | Year | 12 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020545
