UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between toe grip strength and osteoarthritis of OA
Title of the study (Brief title)	Relationship between toe grip strength and knee OA
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to investigate the relationships between toe grip strength and severity of knee OA, pain, impairment, disability, and alignment of lower extrimity.
Basic objectives2	Others
Basic objectives -Others	Investigation about the relationship between toe grip strength and clinical condition associated with knee OA by cross-sectional study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	toe grip strength, severity of knee OA(Kellgren-Lawrence scale), distance of knee joint space, femoro-tibial angle
Key secondary outcomes	WOMAC score

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 of osteoarthritis of knee
Key exclusion criteria	patients with TKA, severe trauma or any other orthopaedic disease, history of operation, nurological problem, or foot dysfunction caused by200 diabetes mellitus.
Target sample size	200

Research contact person
Name of lead principal investigator	Daisuke Uritani
Organization	Kio University
Division name	Department of Physical Therapy, Faculty of Health Science
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara prefecture
TEL	0745-54-1601
Email	d.uritani@kio.ac.jp

Public contact
Name of contact person	Daisuke Uritani
Organization	Kio University
Division name	Department of Physical Therapy, Faculty of Health Science
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara prefecture
TEL	0745-54-1601
Homepage URL
Email	d.uritani@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	kio University

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	2013 Year 04 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 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	Published
URL releasing results	http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0186454
Results
Other related information	Cross-sectional study

Management information
Registered date	2013 Year 04 Month 14 Day
Last modified on	2017 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012265