UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of physiotherapy program after total knee arthroplasty.
Title of the study (Brief title)	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	Kasumi Konnno
Organization	St.Luke's International Hospital
Division name	Department of Rehabilitation
Address	9-1 Akashi-cho,Chuo-ku,Tokyo
TEL	03-3541-5151
Email	konmi@luke.ac.jp

Public contact
Name of contact person	Kasumi Konnno
Organization	St.Luke's International Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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