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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
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 15, 2012
    Last Updated
    January 24, 2012
    Sponsor
    University of Portsmouth
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    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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