Condition category
Circulatory System
Date applied
22/03/2019
Date assigned
30/03/2019
Last edited
29/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
hjung@cs.umass.edu

Trial website

Contact information

Type

Public

Primary contact

Mr Hee-Tae Jung

ORCID ID

http://orcid.org/0000-0001-8921-570X

Contact details

College of Information and Computer Sciences
University of Massachusetts Amherst
Amherst
01003
United States of America
+1 (0)4135452744
hjung@cs.umass.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2018-4728

Study information

Scientific title

Effectiveness of a self-administered serious game for cognitive rehabilitation in chronic stroke survivors with mild cognitive impairment: a randomized controlled trial

Acronym

Neuro-World Clinical Study

Study hypothesis

Self-administration of Neuro-World, mobile cognitive rehabilitation games, can improve cognitive function of chronic-stage stroke patients.

Ethics approval

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: ncswett@ora.umass.edu), Protocol ID: 2018-4728

Study design

Single-center randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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))

Intervention

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.

Intervention type

Device

Phase

Phase II

Drug names

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

15/09/2017

Overall trial end date

30/10/2018

Reason abandoned (if study stopped)

Eligibility

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 in 2 clusters (1 experimental group, 1 passive control group), and 25 participants for each cluster

Participant exclusion criteria

Visual neglect

Recruitment start date

05/06/2018

Recruitment end date

05/07/2018

Locations

Countries of recruitment

Korea, South

Trial participating centre

Heeyeon Rehabilitation Hospital
25 Woni-daero, Gyeongsangnam-do
Changwon
51420
Korea, South

Sponsor information

Organisation

University of Massachusetts Amherst

Sponsor details

Venture Way Center
100 Venture Way
Suite 201
Hadley
01035
United States of America
+1 (0)4135453428
ncswett@ora.umass.edu

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/03/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/03/2019: Trial's existence confirmed by University of Massachusetts Amherst Institutional Review Board.