UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040107 |
|---|---|
| Receipt number | R000045727 |
| Scientific Title | The Effect of Virtual Reality-based Intervention Program on Cognition in Older Adults with Mild Cognitive Impairment: A Randomized Control Trial |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2020/05/22 13:48:00 |
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Basic information
Public title
The Effect of Virtual Reality-based Intervention Program on Cognitive and brain function in older adults
Acronym
The Effect of Virtual Reality-based Intervention Program on Cognitive and brain function in older adults
Scientific Title
The Effect of Virtual Reality-based Intervention Program on Cognition in Older Adults with Mild Cognitive Impairment: A Randomized Control Trial
Scientific Title:Acronym
Effect of VR intervention on MCI older adults
Region
| Asia(except Japan) |
Condition
Condition
Mild Cognitive Impairment (MCI)
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effect of VR training on Cognition and brain function of MCI older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The VR training significantly improved cognitive and brain function of the intervention group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
VR-based cognitive training (24 session, 100 minute per each session) with educational program for general health
Interventions/Control_2
educational program for general health
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
| 55 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals diagnosed with MCI by clinicians and dementia relief center.
2. Have no serious orthopedic and dizziness diseases
3. Who aged 55 to 85 years old
Key exclusion criteria
<55 years and >85 years adults
Have dementia through past psychiatric or neurological diagnosis.
Have a serious dizziness and otolaryngological diagnosis.
Those who did not agree participate and not obtained Informed consent.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | HYUNTAE |
| Middle name | |
| Last name | PARK |
Organization
DONG-A UNIVERSITY
Division name
DEPARTMENT OF HEALTH CARE SCIENCES
Zip code
49315
Address
NAKGDONG DAERO 550 BEONGIL 37 DONG-A UNIVERSITY, BUSAN, SOUTH KOREA
TEL
+82-51-200-7517
htpark@dau.ac.kr
Public contact
Name of contact person
| 1st name | HYUNTAE |
| Middle name | |
| Last name | PARK |
Organization
DONG-A UNIVERSITY
Division name
DEPARTMENT OF HEALTH CARE SCIENCES
Zip code
49315
Address
NAKGDONG DAERO 550 BEONGIL 37 DONG-A UNIVERSITY, BUSAN, SOUTH KOREA
TEL
+82-51-200-7517
Homepage URL
htpark@dau.ac.kr
Sponsor or person
Institute
DONG-A UNIVERSITY, DEPARTMENT OF HEALTH CARE SCIENCES
Institute
Department
Personal name
Funding Source
Organization
DONG-A UNIVERSITY
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
SOUTH KOREA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dong-A University
Address
NAKDONG DAERO 550 BEONGIL 37 , BUSAN, SOUTH KOREA
Tel
+82-51-200-6404
yys1108@dau.ac.kr
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 | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Target sample>
-100 subjects were recruited but 32 subjects didn't participate. Hence our study consisted of total 68 subjects.
Management information
Registered date
| 2020 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045727
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
