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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024196
Receipt No. R000027856
Scientific Title The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Date of disclosure of the study information 2016/09/28
Last modified on 2017/11/12

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Basic information
Public title The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Acronym Effects of preoperative rehabilitation program on outcomes after TKA
Scientific Title The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym Effects of preoperative rehabilitation program on outcomes after TKA
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 preoperative exercise with tibial internal rotation on improving knee kinematics and clinical outcomes after total knee arthroplasty
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee joint kinematics
Key secondary outcomes Knee flexion angle, WOMAC, SF-36

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Novel knee rehabilitation (3 months) (tibial internal-external rotation with knee bending, Leg flexion/extension with tibial internal-rotation, knee-out squat
Interventions/Control_2 Traditional knee rehabilitation(3 months)
(quad setting, active straight leg raising, hip abduction, hip lift)
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 (a) Japanese males and females, (b) between 50 and 80 years old, (c) primary medial compartment knee osteoarthritis, (d) radiographic severity classified using Kellgren-Lawrence System was grade III to grade IV.
Key exclusion criteria (a) lateral compartment knee osteoarthritis, (b) history of knee surgery, (c) receiving some kind of rehabilitation program, (d) subject who has a serious disease on knee joint, (e) history of rheumatoid arthritis, cerebropathy, neuropathy, gout.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Gamada
Organization Graduate School of Hiroshima International University
Division name Medical Technology and Health Welfare Sciences
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 Hoshi
Organization Graduate School of Hiroshima International University
Division name Medical Technology and Health Welfare Sciences
Zip code
Address 555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL 0823-70-4550
Homepage URL
Email pt.hoshiken@gmail.com

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
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 広島県立障害者リハビリテーションセンター(広島県)/広島県立障害者リハビリテーションセンター(広島県) / Hiroshima Prefectural Rehabilitation center(Hiroshima)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 28 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
2012 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 03 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 27 Day
Last modified on
2017 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027856

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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