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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026481
Receipt No. R000030415
Scientific Title Effectiveness of Virtual Reality Balance Exercises in Patients Undergone Knee Joint Replacement
Date of disclosure of the study information 2017/03/09
Last modified on 2018/03/10

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Basic information
Public title Effectiveness of Virtual Reality Balance Exercises in Patients Undergone Knee Joint Replacement
Acronym Effectiveness of Virtual Reality Balance Exercise after Knee Joint Replacement
Scientific Title Effectiveness of Virtual Reality Balance Exercises in Patients Undergone Knee Joint Replacement
Scientific Title:Acronym Effectiveness of Virtual Reality Balance Exercise after Knee Joint Replacement
Region
Japan

Condition
Condition Knee Osteoarthritis
Avascular necrosis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fall incidence of patients undergone knee joint replacement is the same as the elderly person. It was reported that virtual reality balance exercises were effective to decrease fall incidence and improve balance ability for the elderly person. The purpose of this study is to clarify effectiveness of virtual reality balance exercise after knee joint replacement.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed Up and Go test
Key secondary outcomes The falls efficacy scale-international
Four Steps Square Test
360 Degree turn test
Star Excursion Balance Test
2 step test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Standard exercise and virtual reality balance exercise
6 weeks, 1 or 2 times per week, 60 minutes per day
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritis/ Avascular necrosis
Primary surgery
Unicompartmental knee arthroplasty or Total knee arthroplasty
unilateral or bilateral surgery
Key exclusion criteria Severe visual or vestibular impairments
Severe cardiovascular or nervous system disease
Musculoskeletal disorder
Cognitive disease
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Tazawa
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Email tzwtm0pt@reha.sonodakai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Tazawa
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Homepage URL
Email tzwtm0pt@reha.sonodakai.or.jp

Sponsor
Institute Sonodakai Joint Replacement Center Hospital
Institute
Department

Funding Source
Organization iDEACLOUD inc.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 03 Month 09 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
2017 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 10 Day
Date of closure to data entry
2018 Year 03 Month 10 Day
Date trial data considered complete
2018 Year 03 Month 10 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2018 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030415

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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