UMIN-CTR Clinical Trial

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
Email	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
Email	iwata@rehab.osakafu-u.ac.jp

Sponsor
Institute	Osaka Prefecture University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020545