UMIN-CTR Clinical Trial

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