Multi-player Online Video Games for Cognitive Rehabilitation
Primary Purpose
Acquired Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Play game
Sponsored by
About this trial
This is an interventional basic science trial for Acquired Brain Injury focused on measuring Brain injury, Cognitive rehabilitation, Video game
Eligibility Criteria
Inclusion Criteria:
- Have survived an acquired brain injury
- Have progressed through the acute stage of treatment and rehabilitation
- Be attending a day centre periodically
- Have an interest in playing video games
- Be physically capable of playing a video game, with adjustments to the user interface as required
- Be capable of giving or withholding consent
- Have access to suitable computer with internet access at day centre
Exclusion Criteria:
- Any history of photosensitive epilepsy
- Any history of ill effects due to playing video games, or if any ill-effects are shown when playing video games
- On advice of medical staff or carer
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GamePlay
Arm Description
Outcomes
Primary Outcome Measures
Player in-game activity data
All player activity is logged on server with timestamp. Data to be logged:
Player movement (ID, location, timestamp)
Messages sent (Sender and recipient IDs, text, timestamp)
In-game objects created or modified (participant ID, object ID, object type, timestamp)
Each weekly session will produce one block of this data. The 21 blocks constitute time series data which will be analysed for evidence of improvement in cognitive skills.
Secondary Outcome Measures
Player attitudes
Each session in debriefing, players will be asked about their attitudes and feelings about the effects of playing video games
Full Information
NCT ID
NCT01518010
First Posted
January 15, 2012
Last Updated
January 24, 2012
Sponsor
University of Portsmouth
1. Study Identification
Unique Protocol Identification Number
NCT01518010
Brief Title
Multi-player Online Video Games for Cognitive Rehabilitation
Official Title
Multi-player Online Video Games for Cognitive Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research project aims to find out if a multiplayer online video game can provide therapeutic benefit for people who have survived a brain injury.
Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008). These positive emotional effects may enhance cognitive rehabilitation, because the cognitive and emotional sides of rehabilitation are connected (Mateer, 2005).
The hypothesis is thus: that playing multiplayer online games can be a useful form of cognitive rehabilitation for brain-injured people.
This research will identify whether or not multi-player online video games may be used as a complementary therapeutic tool. A further aim is to develop guidelines which would help others considering the use of video games for cognitive rehabilitation.
Detailed Description
Purpose and design
This research aims to find out if massively multi-player online games (MMOs), a relatively new type of video game, can be used as a form of therapy for people who have survived an acquired brain injury.
Numerous previous studies have shown that video games can be used as therapy in many contexts. However, there is some evidence that video games are not an effective form of cognitive rehabilitation for brain injury survivors (Malec et al., 1984). The difference in this research is that MMOs incorporate social interaction into the game play experience. It is proposed that this strengthening of social bonds will be more beneficial than a similar single-player game.
Due to the narrow focus of the research it is anticipated that the number of potential participants will be small, on the order of ten participants. It is recognised that such a small sample size is not compatible with a randomised controlled trial. Instead, the research will employ a single-subject research design, where a higher number of participants will strengthen the external validity of the results.
The research question and design have been developed primarily by the Chief Investigator (PhD student), with critique from the supervisory team. Feedback has also been received from healthcare professionals who have been contacted by the C.I.
Participants will be asked for their feedback on a video game and its user interface. This is to ensure that the video game is suitable for the participant, and that the participant is able to play it. This stage is expected to consist of three or four sessions of 30 mins duration, every 2 weeks.
Participants will then be asked to play the video game for a number of sessions. The number of sessions is 21. The duration of each session is one hour. The sessions are to be held once per week.
Null/alternative hypotheses
The null hypotheses are that a single-player video game will not improve cognitive skills; and that a multi-player online video game will not improve cognitive skills. The alternative hypotheses are that a single-player game will improve cognitive skills, and a multi-player online game will provide further improvement.
Study design
The first stage of the research will be to design and refine a prototype online multi-player video game, working in collaboration with participants, firstly able-bodied, and then disabled. The researcher will work with each participant to develop a user interface which enables him or her to play the video game.
The study will then employ a single-case research design for each disabled participant. An RCT would not be valid given the expected number of participants. Time-series data will be collected in three phases: to obtain a baseline; to measure the effects of a single-player video game; and to measure the effects of a multi-player online game. Each phase has seven sessions. The sessions are one hour, weekly.
During the baseline phase, The participant will engage in a non-game task using the interface defined in the pre-trial phase. This phase may compensate for researcher effects. For the next phase, the participant will engage in a single-player version of the video game. For the final phase, the participant will engage in a multi-player online game.
Player activity in the single- and multi-player games will be logged for analysis. Interviews with participants will be used to build a thick narrative of each participants' experience over the course of the study.
Recruitment
Participants will be recruited by contacting head injury units, day care centres, and organisations such as Headway and the ARNI Trust. The C.I. will meet with potential participants who express an interest in the study.
A cornerstone of rehabilitation is that the goals are relevant to the client's everyday life. Therefore the details of how any individual's cognitive improvements will be measured must be based on a dialogue with each individual.
Consent
Informed consent must be given by a participant before any involvement in the study.
A participant information sheet will be provided. The C.I. will be present to talk through the issues with the participant. The NHS guidelines for writing clear information sheets will be followed.
Due to the nature of the participants' injuries, particular care and emphasis is placed on establishing capacity to give consent. The Department of Health gives guidelines on gauging capacity but family members and care workers will be a key source of guidance.
It is expected that participants will provide a written signature on a consent form, but again due to the nature of the participant's injuries this may not be possible. In this case the verbal consent of the participant would be recorded and witness(es) would sign the form.
Risks, burdens and benefits
The main medical risk of playing video games is the possibility of epileptic seizure due to photosensitive epilepsy, (PSE). Minor risks are: the possibility of aches and pains; eye strain; and stress caused by extended periods of vigilance. These risks are mitigated by conducting the research at day care centres where medical staff will be on hand, and by limiting play to one hour per week, broken into smaller play sessions (e.g. 3 * 20 mins). Additionally, again to minimise risk of photosensitive seizure, screen luminance will be kept to a minimum.
Other issues to consider when using video games as therapy are: video game "addiction"; violent content; and the offensive nature of some games. The issue of any potential addiction is mitigated by the short playing times; the issue of game suitability will be managed by previewing and discussing game content with participant, family members and carers as appropriate.
Potential benefits to participants: Playing a suitable game should provide feelings of well-being and improved self esteem. With the added social aspect of multi-player online games, participants could also feel less isolated. These improvements in emotional health may have beneficial effects on cognitive skills such as communication.
Confidentiality
Participant personal details will be kept confidential. When data is reported, random numeric IDs will be used to refer to individuals. Guidelines issued by the Office of National Statistics will be followed when tabulated data contains cells with zeros or extremely low numbers, so that potential identification of participants is prevented.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Brain injury, Cognitive rehabilitation, Video game
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GamePlay
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Play game
Intervention Description
Participants engage in non-game activity (establish baseline) 7 * 1 hr weekly; play single-player game 7 * 1 hr weekly; play multi-player game 7 * 1 hr weekly.
Primary Outcome Measure Information:
Title
Player in-game activity data
Description
All player activity is logged on server with timestamp. Data to be logged:
Player movement (ID, location, timestamp)
Messages sent (Sender and recipient IDs, text, timestamp)
In-game objects created or modified (participant ID, object ID, object type, timestamp)
Each weekly session will produce one block of this data. The 21 blocks constitute time series data which will be analysed for evidence of improvement in cognitive skills.
Time Frame
Time series data collected each hourly session, weekly, for 21 weeks
Secondary Outcome Measure Information:
Title
Player attitudes
Description
Each session in debriefing, players will be asked about their attitudes and feelings about the effects of playing video games
Time Frame
Weekly , for 21 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have survived an acquired brain injury
Have progressed through the acute stage of treatment and rehabilitation
Be attending a day centre periodically
Have an interest in playing video games
Be physically capable of playing a video game, with adjustments to the user interface as required
Be capable of giving or withholding consent
Have access to suitable computer with internet access at day centre
Exclusion Criteria:
Any history of photosensitive epilepsy
Any history of ill effects due to playing video games, or if any ill-effects are shown when playing video games
On advice of medical staff or carer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason E Colman
Email
jason.e.colman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason E Colman
Organizational Affiliation
University of Portsmouth
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
Mateer, C. (2005) Fundamentals of cognitive rehabilitation. In Halligan, P., and Wade, D. (Eds.) Effectiveness of rehabilitation for cognitive defects. Oxford University Press
Results Reference
background
PubMed Identifier
16020833
Citation
Griffiths M. Video games and health. BMJ. 2005 Jul 16;331(7509):122-3. doi: 10.1136/bmj.331.7509.122. No abstract available.
Results Reference
background
PubMed Identifier
18537505
Citation
Wang CC, Wang CH. Helping others in online games: prosocial behavior in cyberspace. Cyberpsychol Behav. 2008 Jun;11(3):344-6. doi: 10.1089/cpb.2007.0045.
Results Reference
background
Citation
Malec, J., Jones, R., Rao, N., Stubbs, K. (1984) Video game practice effects on sustained attention in patients with craniocerebral trauma. Cognitive Rehabilitation 2 (4): 18 - 23
Results Reference
background
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Multi-player Online Video Games for Cognitive Rehabilitation
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