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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040107
Receipt No. 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

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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
Email 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
Email htpark@dau.ac.kr

Sponsor
Institute DONG-A UNIVERSITY, DEPARTMENT OF HEALTH CARE SCIENCES
Institute
Department

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
Email 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
URL(English) https://upload.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


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