UMIN-CTR Clinical Trial

Basic information
Public title	Research on the Effect of Markerless Augmented Reality N-back Task Game on Improving Working Memory of Youth
Acronym	MARNback
Scientific Title	Research on the Effect of Markerless Augmented Reality N-back Task Game on Improving Working Memory of Youth
Scientific Title:Acronym	MARNback
Region	Asia(except Japan)

Condition
Condition	Working memory
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measure effectiveness of augmented reality n-back training on working memory
Basic objectives2	Others
Basic objectives -Others	Measure experience of immersion in augmented reality n-back training
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Performance on Cambridge Cognition (CANTAB) Spatial Working Memory test, measured pre and post training
Key secondary outcomes	Immersion experience

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	Other
Interventions/Control_1	Augmented reality n-back training played on touchscreen tablet. dose: two 3-minute training sessions, daily, for 4 days.
Interventions/Control_2	2-dimensional n-back training played on touchscreen tablet. dose: two 3-minute training sessions, daily, for 4 days.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Undergraduate students
Key exclusion criteria	None
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Bo Middle name Last name Zhang
Organization	East China Normal University(ECNU)
Division name	Department of Education Information Technology, Faculty of Education
Zip code	200062
Address	No. 3663, North Zhongshan Road, Putuo district, Shanghai, China.
TEL	008613505194318
Email	bzhang@ed.ecnu.edu.cn

Public contact
Name of contact person	1st name Bo Middle name Last name Zhang
Organization	East China Normal University(ECNU)
Division name	Department of Education Information Technology, Faculty of Education
Zip code	200062
Address	No. 3663, North Zhongshan Road, Putuo district, Shanghai, China.
TEL	008613505194318
Homepage URL
Email	bzhang@ed.ecnu.edu.cn

Sponsor
Institute	Department of Education Information Technology, Faculty of Education, East China Normal University(ECNU).
Institute
Department

Funding Source
Organization	Education Youth Program of Shanghai Philosophy and Social Science Planning Project under grant B2021001.
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	China

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

IRB Contact (For public release)
Organization	University Committee on Human Research Protection, East China Normal University (ECNU)
Address	No. 3663, North Zhongshan Road, Putuo district, Shanghai, China.
Tel	0086-021-62232621
Email	apply.irb@admin.ecnu.edu.cn

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	2021 Year 08 Month 30 Day

Related information
URL releasing protocol	none
Publication of results	Partially published

Result
URL related to results and publications	https://journals.sagepub.com/doi/full/10.1177/21582440211014507
Number of participants that the trial has enrolled	60
Results	Both intervention and control groups showed improved performance on CANTAB spatial working memory test. Control group improved significantly more than intervention group on easier trials of the CANTAB spatial working memory test. The intervention group improved more than the control group on the more difficult trials of the CANTAB spatial working memory test, but this difference was not significant
Results date posted	2021 Year 08 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	A total of 60 participants took part in the experiment (average age = 19.33 years, SD = 1.15 years, 29 females). They were undergraduate students from a university in China.
Participant flow	30 participants in the control group and 30 in the intervention. All participants completed the pre- tests, full training, and post- tests.
Adverse events	None
Outcome measures	Cambridge Cognition Spatial Working Memory. User experience questionnaire. Immersive Experience Questionnaire (IEQ).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 28 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 30 Day
Last modified on	2021 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051725