UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026481 |
|---|---|
| Receipt number | 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 14:51:39 |
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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
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
tzwtm0pt@reha.sonodakai.or.jp
Sponsor or person
Institute
Sonodakai Joint Replacement Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030415
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
