UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021794 |
|---|---|
| Receipt number | R000025135 |
| Scientific Title | Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty |
| Date of disclosure of the study information | 2016/04/07 |
| Last modified on | 2016/10/07 09:48:42 |
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Basic information
Public title
Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Acronym
Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Scientific Title
Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Scientific Title:Acronym
Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Region
| Japan |
Condition
Condition
Total knee arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of improvement of functional activity and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.
Basic objectives2
Others
Basic objectives -Others
The purpose of improvement of pain and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale
Key secondary outcomes
Maximum voluntary isometric knee extension force, Timed Up and Go test, 2 minites walk test,Pain Catastrophizing Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)
Interventions/Control_2
traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)
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
underwent a primary unilateral Total knee arthroplasty.
Key exclusion criteria
bone and joint desease, neurological disorders with motor paralysis, dementia, inability to give informed consent form.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshida Yosuke |
Organization
YamatoKashihara Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
81, Isikawa-cho, Kashihara-shi, Nara
TEL
0744-27-1071
fortunatefield@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshida Yosuke |
Organization
YamatoKashihara Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
81, Isikawa-cho, Kashihara-shi, Nara
TEL
0744-27-1071
Homepage URL
fortunatefield@yahoo.co.jp
Sponsor or person
Institute
YamatoKashihara Hospital
Institute
Department
Personal name
Funding Source
Organization
No outside funding was utilized in this trial.
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
| 2016 | Year | 04 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2016 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025135
