UMIN-CTR Clinical Trial

Basic information
Public title	Effects of virtual reality exercise in patients undergone total knee arthroplasty: Randomized controlled trial
Acronym	Effects of virtual reality exercise after total knee arthroplasty
Scientific Title	Effects of virtual reality exercise in patients undergone total knee arthroplasty: Randomized controlled trial
Scientific Title:Acronym	Effects of virtual reality exercise after total knee arthroplasty
Region	Japan

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

Objectives
Narrative objectives1	Serious injuries such as periprosthetic fracture can happen for patients who undergone total knee arthroplasty (TKA) after a fall. It has been reported that virtual reality exercise is effective for healthy elderly people in improving balance function. The purpose of this study was to investigate the effect of virtual reality exercise in patients undergone TKA.
Basic objectives2	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Intervention group Standard rehabilitation (45min) and virtual reality exercise (15min) 6 weeks, 1 or 2 times per week
Interventions/Control_2	Conrtol group Standard rehabilitation (60min) 6weeks, 1 or 2 times per week
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 Primary surgery PCL retaining type implant 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	40

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Tazawa
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Zip code	121-0064
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	+81358311811
Email	tzwtm0pt@reha.sonodakai.or.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Tazawa
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Zip code	121-0064
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	+81358311811
Homepage URL
Email	tzwtm0pt@reha.sonodakai.or.jp

Sponsor
Institute	Sonodakai Joint Replacement Center Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	11080

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sonoda ethics committee
Address	1-21-10, Hokima, Adachi, Tokyo
Tel	+81358311811
Email	irb@sonodakai.or.jp

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	2020 Year 03 Month 20 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	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 05 Month 31 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 12 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	2020 Year 03 Month 20 Day
Last modified on	2020 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045489