UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Title of the study (Brief title)	Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Region	Japan

Condition
Condition	Osteoarthritis of the knee
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effectiveness of combination of the leg-press exercises with tibial internal rotation and insoles for support of lateral longitudinal arch of foot for osteoarthritis of the knee.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analogue Scale before and after intervention (4 weeks)
Key secondary outcomes	Each outcome was measured before and after intervention (4 weeks). Knee extension/flexion angle, Q-angle, single-leg standing time,6-minutes walking, WOMAC, JOA score, SF-36, MRI

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	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervention for 4 weeks, 3 times a week. Tibial internal-external rotation exercise, knee flexion/extension exercise with tibial internal-rotation, knee-out squat
Interventions/Control_2	Intervention for 4 weeks, 3 times a week. Tibial internal-external rotation exercise, knee flexion/extension exercise with tibial internal-rotation, knee-out squat, and towel stepping-on exercise. Using insole daily together.
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	40 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Osteoarthritis of the knee 2) Males and females aged between 40 and 70 years old
Key exclusion criteria	1) History of injuries of lower extremity 2) History of operation of lower extremity 3) Walking disability caused by symptoms of other joints 4) Neuropthy 5) Risks of internal medicine 6) Disability of communication 7) Disability of understanding study protocol 8) Pregnancy
Target sample size	40

Research contact person
Name of lead principal investigator	Masashi Sadakiyo
Organization	Sadamatsu Hospital
Division name	Department of Rehabilitation
Address	537, Higashi-honmachi, Ohmura-city, Nagasaki, Japan
TEL	0957-54-1161
Email	m.sadakiyo@gmail.com

Public contact
Name of contact person	Masashi Sadakiyo
Organization	Sadamatsu Hospital
Division name	Department of Rehabilitation
Address	537, Higashi-honmachi, Ohmura-city, Nagasaki, Japan
TEL	0957-54-1161
Homepage URL
Email	m.sadakiyo@gmail.com

Sponsor
Institute	Sadamatsu Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Hiroshima International University
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	貞松病院（長崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 02 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2017 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032972