UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between hip joint muscle strength or muscle activity ratio and knee joint mechanical stress during walking in patients with knee osteoarthritis
Title of the study (Brief title)	Relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis
Region	Japan

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

Objectives
Narrative objectives1	To investigate relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Mechanical stress of knee joint during walking by Accelerater
Key secondary outcomes	The hip musculature strength ratio and Muscle activity ratio, knee Pain during walking, hip and knee Range of motion

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. kellgren and Lawrence grade 2-4 2. can walk unassisted more than 16m 3. with knee pain during walking
Key exclusion criteria	1. History of severe orthopedic disease excluding knee osteoarthritis, other neurological disorders
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroaki Yamano
Organization	Kio University
Division name	Graduate School of Health Science
Address	4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL	+81-745-54-1601
Email	Kio.pt.baseballer@mbr.nifty.com

Public contact
Name of contact person	Hiroaki Yamano
Organization	Kio University
Division name	Graduate School of Health Science
Address	4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL	+81-745-54-1601
Homepage URL
Email	Kio.pt.baseballer@mbr.nifty.com

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Koyama clinic
Name of secondary funｄer(s)

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	畿央大学（奈良県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 31 Day
Anticipated trial start date	2014 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis

Management information
Registered date	2013 Year 12 Month 18 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014752