Plain English Summary
Background and study aims
Rehabilitation games have the potential to enable stroke survivors to repeatedly practice and improve their cognitive function. However, there are no mobile game solutions that are specifically developed for cognitive rehabilitation and clinically tested. The aim of this study is to test Neuro-World, six mobile games developed for cognitive rehabilitation.
Who can participate?
Stroke survivors with mild cognitive function in their chronic stage (1 year or longer since their last onset)
What does the study involve?
Participants are randomly allocated to one of two groups. One group play Neuro-World games for 30 minutes (5 minutes for each game) a day, 2 days a week for 12 weeks in addition to their medical care, while the other group receive only medical care. Participants are assessed before and after the treatment (12 weeks).
What are the possible benefits and risks of participating?
Study subjects may improve their cognitive function by participating in the study. Playing the games may cause eye and mental fatigue.
Where is the study run from?
Heeyeon Rehabilitation Hospital (South Korea)
When is the study starting and how long is it expected to run for?
September 2017 to October 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Hee-Tae Jung
Effectiveness of a self-administered serious game for cognitive rehabilitation in chronic stroke survivors with mild cognitive impairment: a randomized controlled trial
Neuro-World Clinical Study
Self-administration of Neuro-World, mobile cognitive rehabilitation games, can improve cognitive function of chronic-stage stroke patients.
Approved 06/05/2018, University of Massachusetts Amherst Institutional Review Board (Research Compliance Human Research Protection Office (HRPO), 108 Research Administration Building, 70 Butterfield Terrace, Amherst, MA 01003-9242; Tel: +1 (0)413-545-3428; Email: firstname.lastname@example.org), Protocol ID: 2018-4728
Single-center randomized controlled study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Post stroke with mild cognitive impiarment (18 points or greater in K-MMSE) in their chronic stage (1 year or longer since their last onset))
Participants were randomized using a random number generator. An experimental group self-administered 24 30-minute sessions of Neuro-World, six mobile games for cognitive rehabilitation, twice a week for 12 weeks in addition to their medical care while the control group received only medical care.
Primary outcome measure
Overall cognitive function and impairment level measured using Korean Mini-Mental State Examination (K-MMSE) assessed before (baseline) and after the treatment (12 weeks)
Secondary outcome measures
Assessed before (baseline) and after the treatment (12 weeks):
1. Overall cognitive function and impairment level measured using Digit Forward Span (DFS), Digit Backward Span (DBS)
2. Overall depression level measured using Geriatric Depression Scale (GDS)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Stroke survivors with mild cognitive function (18 points or greater in K-MMSE) in their chronic stage (1 year or longer since their last onset)
Target number of participants
50 in 2 clusters (1 experimental group, 1 passive control group), and 25 participants for each cluster
Participant exclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Heeyeon Rehabilitation Hospital
25 Woni-daero, Gyeongsangnam-do
University of Massachusetts Amherst
Venture Way Center
100 Venture Way
United States of America
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The analyzed results will be submitted to a clinical journal by the end of March 2019.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available sharing the data was not part of the study plan, not approved by UMass IRB nor the study participants. Also, it was planned that the raw data would be removed completely once the analyzed results are published in academic journals. The data is currently stored in the secure online storage provided by UMass Amherst. The data is accessible only by researchers with valid authority.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)