UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Acronym	Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Scientific Title	Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Scientific Title:Acronym	Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Region	Japan

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

Objectives
Narrative objectives1	To clarify of the standard value and standard range in physical therapy evaluation of preoperative and postoperative day 14 in patients with knee osteoarthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	maximum isometric muscle strength of knee extensors and flexors, maximum knee joint angles, 5-meter walk test, timed up and go test
Key secondary outcomes

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	1. Patients with knee osteoarthritis 2. Patients with undergoing total knee arthroplasty (TKA) 3. Patients with undergoing unicompartmental knee arthroplasty (UKA)
Key exclusion criteria	1. Patients with neurological symptoms problem 2. Patients with limited of movements by significant pain or limited range of motion impairment except the knee joint 3. Patients with dementia or psychiatric disease
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuya Amano
Organization	Tokoha University
Division name	Faculty of Health and Medical Sciences
Zip code
Address	1230 miyakoda, kita-ku, Hamamatsu, Shizuoka,Japan
TEL	053-428-1211
Email	tamano@hm.tokoha-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuya Amano
Organization	Tokoha University
Division name	Faculty of Health and Medical Sciences
Zip code
Address	1230 miyakoda, kita-ku, Hamamatsu, Shizuoka,Japan
TEL	053-428-1211
Homepage URL	http://physical-therapy-diagnostics-group.kenkyuukai.jp/about/index.asp?
Email	tamano@hm.tokoha-u.ac.jp

Sponsor
Institute	Tokoha University
Institute
Department

Funding Source
Organization	Tokoha 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
Address
Tel
Email

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 04 Month 01 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	2013 Year 06 Month 17 Day
Date of IRB	2016 Year 12 Month 15 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective cohort study

Management information
Registered date	2017 Year 04 Month 01 Day
Last modified on	2020 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030746