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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040935
Receipt No. R000046733
Scientific Title Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Date of disclosure of the study information 2020/06/29
Last modified on 2020/06/28

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Basic information
Public title Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Acronym Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Scientific Title Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Scientific Title:Acronym Interlimb coordination in patients undergoing total hip arthroplasty and total knee arthroplasty
Region
Japan

Condition
Condition hip osteoarthritis, knee osteoarthritis
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare interlimb coordination in patients before and after THA and TKA, and to examine the relationship between inter limb coordination with quality of life. Additionally, we investigate its association with other variables at each time.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase coordination index (pre, 3weeks, 3months and 1year after surgery)
Key secondary outcomes Quality of life(1year after surgery)
Lower limb strength(pre, 3weeks, 3months and 1year after surgery)
Lower limb angular velocity(pre, 3weeks, 3months and 1year after surgery)
Lower limb range of motion(pre, 3weeks, 3months and 1year after surgery)
Fall history(1year after surgery)

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 who had total hip arthroplasty or total knee arthroplasty
The ability to walk 30 m or more without assistance
Key exclusion criteria A participant was excluded if patients had any medical or neurological problem that would affect their ability to complete this trial, such as severe dementia, stroke, cardiac insufficiency, or acute respiratory failure.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Wanaka
Organization Kobe Rosai Hospital
Division name Central Rehabilitation Department
Zip code 651-0053
Address 4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL 078-231-5901
Email rosai@kobeh.johas.go.jp

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Wanaka
Organization Kobe Rosai Hospital
Division name Central Rehabilitation Department
Zip code 651-0053
Address 4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL 078-231-5901
Homepage URL
Email rosai@kobeh.johas.go.jp

Sponsor
Institute Kobe Rosai Hospital
Institute
Department

Funding Source
Organization None
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 Kobe Rosai Hospital
Address 4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
Tel 078-231-5901
Email rosai@kobeh.johas.go.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
2020 Year 06 Month 29 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
2020 Year 03 Month 23 Day
Date of IRB
2020 Year 04 Month 03 Day
Anticipated trial start date
2020 Year 04 Month 06 Day
Last follow-up date
2025 Year 04 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cohort study
Patients admitted to the orthopedic department of Kobe Rosai Hospital, diagnosed with hip or knee OA and scheduled for THA and TKA.
Measurement items include demographics, phase coordination index, lower extremity muscle strength, lower extremity joint angular velocity, lower extremity joint range of motion, and pain.

Management information
Registered date
2020 Year 06 Month 28 Day
Last modified on
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046733

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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