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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028624
Receipt No. 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 2019/10/01

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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
Email 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
Email asakuri@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information From June 1, 2017 to August 31, 2019, subjects receive explanation about the outline of the research from their physical therapist. The researcher in charge explains the details of the research to the subjects who show interest to participation. Subjects decide accept the participation or not by free will.
Physical therapy are done as usual without special interventions.
The subjects are assessed at 2 weeks after arthroplasty and at discharging hospital. And
the data assessed before arthloplasty are also used for analysis.

Management information
Registered date
2017 Year 08 Month 10 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031105

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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