UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030187 |
|---|---|
| Receipt number | 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 13:04:29 |
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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
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
jpark@dau.ac.kr
Sponsor or person
Institute
N/A
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034479
