Can playing Neuro-World mobile games improve cognitive function in people who have had a stroke 2 years or more previously?
| ISRCTN | ISRCTN10613029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10613029 |
| Secondary identifying numbers | 2018-4728 |
- Submission date
- 22/03/2019
- Registration date
- 30/03/2019
- Last edited
- 08/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Public
College of Information and Computer Sciences
University of Massachusetts Amherst
Amherst
01003
United States of America
 ORCID ID |
0000-0001-8921-570X |
|---|---|
| Phone | +1 (0)4135452744 |
| hjung@cs.umass.edu |
Study information
| Study design | Single-center randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of self-administered cognitive rehabilitation games in chronic stroke survivors with mild-to-moderate cognitive impairment: a randomized controlled trial |
| Study 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(s) | 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 |
| Condition | Stroke survivors with mild-to-moderate cognitive impairment (18 points or greater in K-MMSE) in their chronic stage (2 years 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 15/09/2017 |
| Overall study end date | 30/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 in 2 clusters (1 experimental group, 1 passive control group), and 25 participants for each cluster |
| Participant inclusion criteria | Current inclusion criteria as of 06/01/2020: Stroke survivors with mild-to-moderate cognitive impairment (18 points or greater in K-MMSE) in their chronic stage (2 years or longer since their last onset) Previous 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 exclusion criteria | Visual neglect |
| Recruitment start date | 05/06/2018 |
| Recruitment end date | 05/07/2018 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Changwon
51420
Korea, South
Sponsor information
University/education
Venture Way Center
100 Venture Way
Suite 201
Hadley
01035
United States of America
| Phone | +1 (0)4135453428 |
|---|---|
| ncswett@ora.umass.edu | |
"ROR" |
https://ror.org/0072zz521 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The analyzed results will be submitted to a clinical journal by the end of March 2019. |
| IPD sharing plan | 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. |
Editorial Notes
08/01/2020: The public title has been changed from "Effectiveness of a self-administered serious game for cognitive rehabilitation in chronic stroke survivors with mild cognitive impairment: a randomized controlled trial" to "Can playing Neuro-World mobile games improve cognitive function in people who have had a stroke 2 years or more previously?".
06/01/2020: The following changes have been made:
1. The scientific title has been changed from "Effectiveness of a self-administered serious game for cognitive rehabilitation in chronic stroke survivors with mild cognitive impairment: a randomized controlled trial" to "Effectiveness of self-administered cognitive rehabilitation games in chronic stroke survivors with mild-to-moderate cognitive impairment: a randomized controlled trial".
2. The condition has been changed from "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))" to "Stroke survivors with mild-to-moderate cognitive impairment (18 points or greater in K-MMSE) in their chronic stage (2 years or longer since their last onset)".
3. The inclusion criteria have been changed.
29/03/2019: Trial's existence confirmed by University of Massachusetts Amherst Institutional Review Board.
