UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039890 |
|---|---|
| Receipt number | R000045489 |
| Scientific Title | Effects of virtual reality exercise in patients undergone total knee arthroplasty: Randomized controlled trial |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/20 13:11:45 |
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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
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
tzwtm0pt@reha.sonodakai.or.jp
Sponsor or person
Institute
Sonodakai Joint Replacement Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045489
