UMIN-CTR Clinical Trial

Basic information
Public title	The factors for the Gait related self efficacy in patients with knee osteoarthritis
Acronym	The factors for the Gait related self efficacy in patients with knee osteoarthritis
Scientific Title	The factors for the Gait related self efficacy in patients with knee osteoarthritis
Scientific Title:Acronym	The factors for the Gait related self efficacy in patients with knee osteoarthritis
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to reveal the ralationship between gait related self efficacy and physical function, knee pain, health related quality of life, life space.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese-modified Gait efficacy scale Pain catasrophizing scale Life space assesment Range of motion and muscle strength in knee joint knee joint pain gait function
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	50 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Individual who Doctor diagnosed knee osteoarthritis and be possible walking.
Key exclusion criteria	Individual who has no history of orthopedic disease that has obvious influence on gait function other than knee osteoarthritis Individual who have no notable items in neurology or physiology that clearly affect gait function
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Mawarikado Middle name Last name Yuya
Organization	Kashiba Asahigaoka Hospital
Division name	Department of Rehabilitation
Zip code	639-0265
Address	839 Kaminaka, Kashiba City, Nara Prefecture
TEL	0745-77-8101
Email	b9972384@kio.ac.jp

Public contact
Name of contact person	1st name Mawarikado Middle name Last name Yuya
Organization	Kashiba Asahigaoka Hospital
Division name	Department of Rehabilitation
Zip code	639-0265
Address	839 Kaminaka, Kashiba City, Nara Prefecture
TEL	0745-77-8101
Homepage URL
Email	b9972384@kio.ac.jp

Sponsor
Institute	Kashiba Asahigaoka Hospital
Institute
Department

Funding Source
Organization	Graduate school of Kio 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	Kashiba Asahigaoka Hospital
Address	839 Kaminaka, Kashiba City, Nara Prefecture
Tel	0745-77-8101
Email	b9972384@kio.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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Main results already published
Date of protocol fixation	2019 Year 06 Month 16 Day
Date of IRB	2019 Year 05 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Data collected during the period to March 31, 2121, will be used as a retrospective study.

Management information
Registered date	2019 Year 06 Month 16 Day
Last modified on	2020 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042254

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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