UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Virtual Reality Balance Exercises in Patients Undergone Knee Joint Replacement
Title of the study (Brief title)	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	Tomohiro Tazawa
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	03-5831-1811
Email	tzwtm0pt@reha.sonodakai.or.jp

Public contact
Name of contact person	Tomohiro Tazawa
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030415