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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029045
Receipt No. R000032974
Scientific Title Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial
Date of disclosure of the study information 2017/09/29
Last modified on 2019/09/10

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Basic information
Public title Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial
Acronym Effect of exercise therapy with tibial internal-rotation
Scientific Title Effect of exercise therapy with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee: a randomized controlled trial
Scientific Title:Acronym Effect of exercise therapy with tibial internal-rotation
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 exercise with tibial internal-rotation on clinical outcomes and knee kinematics of osteoarthritis of the knee.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee joint kinematics before and after intervention (3 months)
Key secondary outcomes Knee flexion/extension angle, Timed Up & Go Test, 20 m gait, WOMAC, SF-36, MRI, parameters of gait (three-dimensional analysis)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Novel knee exercise therapy with tibial internal-rotation was carried out for 3 months (once a week). Intervention was a manual therapy for improving range of tibial internal-rotation, and 3 exercises: tibial internal-external rotation, knee flexion/extension with tibial internal-rotation, knee-out squat. Participants carried out home-exercise every day.
Interventions/Control_2 Traditional knee exercise therapy was carried out for 3 months at a medical institution (once a week). Intervention was quadriceps muscle training, hip abduction, hip adduction, hip extension, leg press, squat. Participants carried out home-exercise every day.
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) Japanese males and females, 2) between 50 and 80 years old, 3) primary medial compartment knee osteoarthritis, 4) radiographic severity classified using Kellgren-Lawrence classification grade was grade I to grade III.
Key exclusion criteria 1) Lateral compartment knee osteoarthritis, 2) history of knee surgery, 3) receiving some kind of rehabilitation program, 4) subject who has a serious disease on knee joint, 5) history of rheumatoid arthritis, cerebropathy, neuropathy, gout, 6) risk of internal medicine, 7) mental disorder, 8) communication disorder
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuyoshi
Middle name
Last name Gamada
Organization Hiroshima International University
Division name Department of Rehabilitation
Zip code 739-2695
Address 555-36 Kurosegakuendai, Higashihiroshima City, Hiroshima
TEL 0823-70-4550
Email kazgamada@ortho-pt.com

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Kurose
Organization Hiroshima Prefectural Rehabilitation Center
Division name Department of Orthopaedics
Zip code 739-0036
Address 295-3 Taguchi, Saijo-cho, Higashihiroshima City, Hiroshima
TEL 082-425-1455
Homepage URL
Email kurose0156@hiroshima-wsc.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 Hiroshima Prefectural Rehabilitation Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima International University
Address 555-36 Kurosegakuendai, Higashihiroshima City, Hiroshima
Tel 0823-70-4611
Email hu-gjmr1@ofc.hirokoku-u.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 広島県立障害者リハビリテーションセンター(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 29 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 15 Day
Date of IRB
2014 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 01 Month 27 Day
Last follow-up date
2019 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 07 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032974

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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