UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial
Title of the study (Brief title)	Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To determine the effectiveness of a leg-press exercises with tibial internal rotation on improving pain and function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10 m walk test The 10m walk test measuresd it after 20 minutes of intervention.
Key secondary outcomes	timed up-and-go test, knee flexion angle while squatting, knee pain during walking and squatting, difficulty during walking and squatting

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Leg-press activity with tibial internal-rotation (single session)
Interventions/Control_2	Leg-press activity with tibial neutral-rotation (single session)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) age between 50 and 80 years, (2) knee OA with a Kellgren and Lawrence (K/L) grade <4, and (3) knee extension deficit <10 degree
Key exclusion criteria	(1) bilateral knee OA, (2) acute symptoms, (3) rheumatoid arthritis, or (4) previous surgery involving either lower extremity
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuyoshi Gamada
Organization	Hiroshima International University
Division name	Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and Technology
Address	555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL	0823-70-4550
Email	kazgamada@ortho-pt.com

Public contact
Name of contact person	Kenji Hanada
Organization	Hiroshima International University
Division name	Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and T
Address	555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL	0823-70-4550
Homepage URL
Email	guess_kenji@yahoo.co.jp

Sponsor
Institute	Hiroshima International University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuoka Rehabilitation Hospital
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	福岡リハビリテーション病院（福岡）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 09 Day
Anticipated trial start date	2010 Year 07 Month 09 Day
Last follow-up date	2010 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2010 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 02 Day
Last modified on	2016 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024986