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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032977
Receipt No. R000037584
Scientific Title Comparative study of physiotherapy program after total knee arthroplasty.
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/13

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Basic information
Public title Comparative study of physiotherapy program after total knee arthroplasty.
Acronym Comparative study of physiotherapy program after TKA.
Scientific Title Comparative study of physiotherapy program after total knee arthroplasty.
Scientific Title:Acronym Comparative study of physiotherapy program after TKA.
Region
Japan

Condition
Condition Knee osteoarthritis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effective physical therapy program after TKA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Range of motion of the knee after TKA.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Regular rehabilitation grop:During the hospitalization period,exercise for the range of motion by the physiotherapist and regular rehabilitation such as load training and walking exercise are carried out.
Interventions/Control_2 CPM group:Exercise for the range of motion by CPM and regular rehabilitation are carried out.
Interventions/Control_3 Self rehabilitation grop:Exercise for the range of motion by the patient himself and regular rehabilitation are carried out.
They do the self-exercise with DVD instruction.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)Female patient who undergoes TKA for tha OA by the same surgeon ,the same procedure ,the same device in diagnosis of osteoarthritis from 2018 to 2021.
Key exclusion criteria 1)Patients who can not for 10m and more before surgery.
2)Patients with dementia/psychiatric disorders who can not understand exercise instruction.
3)Patients with rheumatoid arthritis,post-trauma surgery and post-revision surgery.
4)Patients with neurological disease in past.
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kasumi Konnno
Organization St.Luke's International Hospital
Division name Department of Rehabilitation
Zip code
Address 9-1 Akashi-cho,Chuo-ku,Tokyo
TEL 03-3541-5151
Email konmi@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kasumi Konnno
Organization St.Luke's International Hospital
Division name Department of Rehabilitation
Zip code
Address 9-1 Akashi-cho,Chuo-ku,Tokyo
TEL 03-3541-5151
Homepage URL
Email konmi@luke.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization St.Luke's International University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037584

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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