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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021751
Receipt No. R000024986
Scientific 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
Date of disclosure of the study information 2016/04/02
Last modified on 2016/04/25

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Basic information
Public 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
Acronym Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial
Scientific 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
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kazuyoshi Gamada
Organization Hiroshima International University
Division name Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and Technology
Zip code
Address 555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL 0823-70-4550
Email kazgamada@ortho-pt.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Hanada
Organization Hiroshima International University
Division name Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and T
Zip code
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

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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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 06 Month 09 Day
Date of IRB
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

Other
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

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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