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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028944
Receipt No. R000032972
Scientific Title Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Date of disclosure of the study information 2017/08/31
Last modified on 2017/08/24

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Basic information
Public title Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Acronym Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Scientific Title Effect of tibial internal-rotation exercise and insole on osteoarthiritis of the knee
Scientific Title:Acronym 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
1st name
Middle name
Last name Masashi Sadakiyo
Organization Sadamatsu Hospital
Division name Department of Rehabilitation
Zip code
Address 537, Higashi-honmachi, Ohmura-city, Nagasaki, Japan
TEL 0957-54-1161
Email m.sadakiyo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Sadakiyo
Organization Sadamatsu Hospital
Division name Department of Rehabilitation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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