UMIN-CTR Clinical Trial

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 gait stability 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 and Harmonic ratio of the trunk acceleration (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	h.wanaka0531@gmail.com

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	research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
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	2021 Year 06 Month 29 Day

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