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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021794
Receipt No. 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

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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
Email 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
Email fortunatefield@yahoo.co.jp

Sponsor
Institute YamatoKashihara Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025135

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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