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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030187
Receipt No. R000034479
Scientific Title Effect and tolerability of virtual reality (VR)-based training program on cognitive function in patients with Mild Cognitive Impairment
Date of disclosure of the study information 2017/11/30
Last modified on 2017/11/30

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Basic information
Public title Effect and tolerability of virtual reality (VR)-based training program on cognitive function in patients with Mild Cognitive Impairment
Acronym Effect and tolerability of virtual reality (VR)-based training program on cognitive function in patients with Mild Cognitive Impairment
Scientific Title Effect and tolerability of virtual reality (VR)-based training program on cognitive function in patients with Mild Cognitive Impairment
Scientific Title:Acronym Effect and tolerability of virtual reality (VR)-based training program on cognitive function in patients with Mild Cognitive Impairment
Region
Asia(except Japan)

Condition
Condition Mild Cognitive Impairment
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was to investigate that effect and tolerability of VR-based training program on cognitive function in patients with mild cognitive impairment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To improve Alzheimer`s disease assessment scale-cognitive score
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Virtual reality based training program - The VR-based training group intervenes for 30 min/day, 2 d/week, 24 times for 3 months. The VR-based program was conducted attention, executive function, memory conditions to stimulate cognitive function
Interventions/Control_2 / self control
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
60 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Global CDF <0.5
Modified Hackinski Ischemic Score <4
Age 50-85
MCI patients
Key exclusion criteria Other cardiovascular disease
Alcohol holic
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyung Won Park
Organization Dong-A University
Division name Department of Neurology, College of Medicine
Zip code
Address Daesingongwon-ro 26, Seo-gu, Busan, 602-715, Rep. of Korea
TEL +82-51-240-2966
Email neuropark@dau.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Jong-Hwan Park
Organization Dong-A University
Division name Institute of Convergence Bio-Health
Zip code
Address Daesingongwon-ro 26, Seo-gu, Busan, 602-715, Rep. of Korea
TEL +82-51-240-2763
Homepage URL
Email jpark@dau.ac.kr

Sponsor
Institute N/A
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 30 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
2016 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034479

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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