UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028624 |
|---|---|
| Receipt number | R000031105 |
| Scientific Title | Transition of the fluidity in patients undergoing knee joint arthroplasty and relationship with clinical measurement |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2024/08/15 17:48:42 |
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Basic information
Public title
Transition of the fluidity in patients undergoing knee joint arthroplasty and relationship with clinical measurement
Acronym
The fluidity of knee joint arthroplasty patients
Scientific Title
Transition of the fluidity in patients undergoing knee joint arthroplasty and relationship with clinical measurement
Scientific Title:Acronym
The fluidity of knee joint arthroplasty patients
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of body function, balance and mobility on the fluidity.
Basic objectives2
Others
Basic objectives -Others
To clarity the transition of the fluidity after knee joint arthroplasty.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fluidity index at 2 weeks after undergoing knee joint arthroplasty and at discharging hospital
Key secondary outcomes
Knee joint range of motion
Knee joint strength
5 times sit to stand test
Functional reach test
Gait velocity
Timed up and go test
Dynamic gait index
Pain
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing knee joint arthroplasty and physical therapy
Key exclusion criteria
The patients with high risk of falling.
The patients with coexist diseases affecting their motions other than knee OA.
The patients who can't understand the instractions.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | TOMOYUKI |
| Middle name | |
| Last name | ASAKURA |
Organization
Gunma University
Division name
Department of rehabilitation, Graduate school of health sciences
Zip code
371-8514
Address
3-39-22, Showamachi, Maebashi, Gunma
TEL
027-220-8947
asakuri@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | TOMOYUKI |
| Middle name | |
| Last name | ASAKURA |
Organization
Gunma University
Division name
Department of rehabilitation, Graduate school of health sciences
Zip code
371-8514
Address
3-39-22, Showamachi, Maebashi, Gunma
TEL
027-220-8947
Homepage URL
asakuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University
Address
3-39-22, Showamachi, Maebashi, Gunma
Tel
027-220-7111
hitotaisho-ciru@ml.gunma-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
| 2017 | Year | 08 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031105
