UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026821 |
|---|---|
| Receipt number | R000030746 |
| Scientific Title | Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/02/09 16:59:16 |
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Basic information
Public title
Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Acronym
Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Scientific Title
Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Scientific Title:Acronym
Establishment of standard value and standard range for physical therapy evaluation in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify of the standard value and standard range in physical therapy evaluation of preoperative and postoperative day 14 in patients with knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum isometric muscle strength of knee extensors and flexors, maximum knee joint angles, 5-meter walk test, timed up and go test
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with knee osteoarthritis
2. Patients with undergoing total knee arthroplasty (TKA)
3. Patients with undergoing unicompartmental knee arthroplasty (UKA)
Key exclusion criteria
1. Patients with neurological symptoms problem
2. Patients with limited of movements by significant pain or limited range of motion impairment except the knee joint
3. Patients with dementia or psychiatric disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Amano |
Organization
Tokoha University
Division name
Faculty of Health and Medical Sciences
Zip code
Address
1230 miyakoda, kita-ku, Hamamatsu, Shizuoka,Japan
TEL
053-428-1211
tamano@hm.tokoha-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Amano |
Organization
Tokoha University
Division name
Faculty of Health and Medical Sciences
Zip code
Address
1230 miyakoda, kita-ku, Hamamatsu, Shizuoka,Japan
TEL
053-428-1211
Homepage URL
http://physical-therapy-diagnostics-group.kenkyuukai.jp/about/index.asp?
tamano@hm.tokoha-u.ac.jp
Sponsor or person
Institute
Tokoha University
Institute
Department
Personal name
Funding Source
Organization
Tokoha University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2017 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030746
