Digital Gaming for Persons With Traumatic Brain Injury

NCT02425527 | Completed DMC

• 1 other identifier: 40109/14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to determine whether digital games are effective and acceptable in the treatment for patients with traumatic brain injury.

Conditions

Brain Injuries; Traumatic Brain Injury; TBI (Traumatic Brain Injury); Injury, Brain, Traumatic; Brain Injuries, Traumatic

Keywords

Brain Injuries; Traumatic Brain Injury; Video Games

Outcome Measures

Primary Outcomes (1)

• Processing speed and visuomotor tasks (Trail Making Test (TMT), WAIS-IV tasks)

  follow-up on 3 months after the last intervention

Secondary Outcomes (6)

• Attention and executive functions (Simon task)

  follow-up on 3 months after the last intervention

• Working memory (The Paced Auditory Serial Addition Test (PASAT), WAIS-IV)

  follow-up on 3 months after the last intervention

• Depression (Patient Health Questionnaire (PHQ-9)

  follow-up on 3 months after the last intervention

• Self-efficacy (General Self-efficacy Scale (GSC)

  follow-up on 3 months after the last intervention

• Executive functions (The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

  follow-up on 3 months after the last intervention

Study Arms (3)

The rehabilitation gaming

EXPERIMENTAL

The rehabilitation gaming group (n=30) will use an internet browser-based digital brain training program CogniFit (https://www.cognifit.com), with a selection of about 33 games.The participants will use the rehabilitation gaming for at least 30 min per day over a period of 8 weeks.

Behavioral: The rehabilitation gaming

The entertaining gaming

ACTIVE COMPARATOR

The entertaining gaming group (n = 30) will use commercial digital games with Sony Playstation 3 (PS3) consoles, played with wireless Sony DualShock gamepad controllers. The participants will be guided to play the console for at least 30 min per day over a period of 8 weeks

Behavioral: The entertaining gaming

"Do-nothing"

NO INTERVENTION

The passive control group "Do-nothing" group (n = 30) will not have gaming activities organized by the project.

Interventions

The rehabilitation gaming BEHAVIORAL

The web-based cognitive training platform CogniFit includes about 33 mini games designed with the purpose of improving the user's cognitive abilities as brain exercises. For the purpose of the research, a selection of CogniFit mini games will be included in the intervention. The mini game tasks will be adapted to players' skills getting more difficult as the players progress. The game tasks are targeting different cognitive abilities such as memory, visual-spatial ability, attention, tracking and fast decision making.

The rehabilitation gaming

The entertaining gaming BEHAVIORAL

The gameplay will consist of these main elements: 1) the player will be playing the main character of the game, 2) the character will be presented for the player from an isometric perspective, 3) the player will control the character by navigating in partly open-ended 3D environments in which the player must decide a direction and move towards it by avoiding obstacles; 4) the player will engage with real-time action events and act quickly by making strategic and tactical decisions; 5) the player must memorize locations, characters, dialogue and tasks; as well as 6) track, follow or aim at several objects simultaneously. Gaming requires also patience as participants can only make progress in games by trial and error.

The entertaining gaming

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with age of 18 - 65 years
• Diagnosis of traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5)
• Having TV screen, computer and internet access at home
• No active digital play gamer (5 hours or less/a week)
• Able to understand, speak and/or read Finnish language
• Willing to participate in the study based on their own free will (a signed written informed consent form)
• Discharged from the neurologic treatment period due to traumatic brain injury over 12 months before possible recruitment
• No active participation in cognitive rehabilitation during the last 3 months

You may not qualify if:

• Age below 18 years or over 65 years of old
• Active digital game player (over 5 hours/a week)
• Sensory, cognitive or physical (severe cognitive impairment, deficiency preventing the use of regular computers unaided or computer game control system (impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system)
• Inability to understand, speak and/or read Finnish language
• Apathy identified in previous neuropsychological evaluations
• Diagnosed severe mental disorders (e.g. schizophrenia or severe depressive disorders to be identified as the secondary diagnosis)
• Unwillingness and/or incapability to participate in the study
• Active cognitive rehabilitation during the last 3 months

Sponsors & Collaborators

• University of Turku: lead
• The Finnish Funding Agency for Technology and Innovation (TEKES): collaborator
• Oy Nordisk Film Ab / Playstation: collaborator
• The Finnish Association of People with Physical Disabilities: collaborator
• TribeFlame Oy: collaborator
• BCB Medical: collaborator
• Validia Kuntoutus Oy: collaborator
• Kuntoutus Orton Oy: collaborator
• Serious Games Finland Oy: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

University of Turku

Turku, 20014, Finland

Location

Related Publications (2)

• Valimaki M, Korkeila J, Kauppi K, Kaakinen JK, Holm S, Vahlo J, Tenovuo O, Hamalainen H, Sarajuuri J, Rantanen P, Orenius T, Koponen A. Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study. JMIR Res Protoc. 2016 Feb 9;5(1):e6. doi: 10.2196/resprot.4841.

  PMID: 26860741 BACKGROUND

• Valimaki M, Mishina K, Kaakinen JK, Holm SK, Vahlo J, Kirjonen M, Pekurinen V, Tenovuo O, Korkeila J, Hamalainen H, Sarajuuri J, Rantanen P, Orenius T, Koponen A. Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Randomized Clinical Feasibility Study. J Med Internet Res. 2018 Mar 19;20(3):e77. doi: 10.2196/jmir.7618.

  PMID: 29555622 RESULT

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maritta Välimäki, Professor

  Faculty of Medicine, Department of Nursing Science, University of Turku

  STUDY DIRECTOR

• Aki Koponen, Dr.

  School of Economics, Centre of Collaborative Research, University of Turku

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 24, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

FI (1)