UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045314
Receipt number R000051725
Scientific Title Research on the Effect of Markerless Augmented Reality N-back Task Game on Improving Working Memory of Youth
Date of disclosure of the study information 2021/08/30
Last modified on 2021/08/30 21:25:45

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name