UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032977 |
|---|---|
| Receipt number | 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 18:12:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
konmi@luke.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037584
