{ "FullStudy":{ "Rank":217697, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518010", "OrgStudyIdInfo":{ "OrgStudyId":"COLMAN" }, "Organization":{ "OrgFullName":"University of Portsmouth", "OrgClass":"OTHER" }, "BriefTitle":"Multi-player Online Video Games for Cognitive Rehabilitation", "OfficialTitle":"Multi-player Online Video Games for Cognitive Rehabilitation" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Not yet recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2014", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 15, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jason Colman", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"University of Portsmouth" }, "LeadSponsor":{ "LeadSponsorName":"University of Portsmouth", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"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.\n\nVideo 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).\n\nThe hypothesis is thus: that playing multiplayer online games can be a useful form of cognitive rehabilitation for brain-injured people.\n\nThis 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.", "DetailedDescription":"Purpose and design\n\nThis 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.\n\nNumerous 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.\n\nDue 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.\n\nThe 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.\n\nParticipants 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.\n\nParticipants 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.\n\nNull/alternative hypotheses\n\nThe 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.\n\nStudy design\n\nThe 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.\n\nThe 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.\n\nDuring 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.\n\nPlayer 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.\n\nRecruitment\n\nParticipants 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.\n\nA 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.\n\nConsent\n\nInformed consent must be given by a participant before any involvement in the study.\n\nA 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.\n\nDue 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.\n\nIt 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.\n\nRisks, burdens and benefits\n\nThe 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.\n\nOther 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.\n\nPotential 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.\n\nConfidentiality\n\nParticipant 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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Acquired Brain Injury" ] }, "KeywordList":{ "Keyword":[ "Brain injury", "Cognitive rehabilitation", "Video game" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"10", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"GamePlay", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Play game" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Play game", "InterventionDescription":"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.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "GamePlay" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Player in-game activity data", "PrimaryOutcomeDescription":"All player activity is logged on server with timestamp. Data to be logged:\n\nPlayer movement (ID, location, timestamp)\nMessages sent (Sender and recipient IDs, text, timestamp)\nIn-game objects created or modified (participant ID, object ID, object type, timestamp)\n\nEach 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.", "PrimaryOutcomeTimeFrame":"Time series data collected each hourly session, weekly, for 21 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Player attitudes", "SecondaryOutcomeDescription":"Each session in debriefing, players will be asked about their attitudes and feelings about the effects of playing video games", "SecondaryOutcomeTimeFrame":"Weekly , for 21 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHave survived an acquired brain injury\nHave progressed through the acute stage of treatment and rehabilitation\nBe attending a day centre periodically\nHave an interest in playing video games\nBe physically capable of playing a video game, with adjustments to the user interface as required\nBe capable of giving or withholding consent\nHave access to suitable computer with internet access at day centre\n\nExclusion Criteria:\n\nAny history of photosensitive epilepsy\nAny history of ill effects due to playing video games, or if any ill-effects are shown when playing video games\nOn advice of medical staff or carer", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Jason E Colman", "CentralContactRole":"Contact", "CentralContactEMail":"jason.e.colman@gmail.com" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jason E Colman", "OverallOfficialAffiliation":"University of Portsmouth", "OverallOfficialRole":"Principal Investigator" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferenceType":"background", "ReferenceCitation":"Mateer, C. (2005) Fundamentals of cognitive rehabilitation. In Halligan, P., and Wade, D. (Eds.) Effectiveness of rehabilitation for cognitive defects. Oxford University Press" },{ "ReferencePMID":"16020833", "ReferenceType":"background", "ReferenceCitation":"Griffiths M. Video games and health. BMJ. 2005 Jul 16;331(7509):122-3." },{ "ReferencePMID":"18537505", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferenceType":"background", "ReferenceCitation":"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" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001930", "ConditionMeshTerm":"Brain Injuries" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000006259", "ConditionAncestorTerm":"Craniocerebral Trauma" },{ "ConditionAncestorId":"D000020196", "ConditionAncestorTerm":"Trauma, Nervous System" },{ "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3789", "ConditionBrowseLeafName":"Brain Injuries", "ConditionBrowseLeafAsFound":"Brain Injury", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7932", "ConditionBrowseLeafName":"Craniocerebral Trauma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20607", "ConditionBrowseLeafName":"Trauma, Nervous System", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }