Digital Gaming Used to Improve the Cognitive Functioning and Well-being of People With Traumatic Brain Injury: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Turku
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Processing speed and visuomotor tasks (Trail Making Test (TMT), WAIS-IV tasks)
Study Overview
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.
Detailed Description
This is a feasibility study using a pragmatic, randomized controlled trial with three arms.
The study will be conducted within the Turku University Hospital, Division of Clinical Neurosciences (Operational Division of Clinical Neurosciences, Department of Rehabilitation and Brain Trauma in collaboration with former neurology outpatient clinic and rehabilitation units of the university hospital). The Division is specialized in demanding neurological and psychiatric inpatient rehabilitation, inter-professional neurological education, rehabilitative examinations, and the inpatient and outpatient care of traumatic brain injuries. In each year, about 500 patients are admitted in the Division services units.
The recruitment will be focused on patients who have been discharged from the Turku University Hospital, Division of Clinical Neurosciences at least one year before the starting day of the recruitment process. Based on the previous literature, using games in longer interventions will be facilitated if training is provided in the persons' home, due to easier access and reduced impact on school or work activities (Burbea et al. 2011).
The randomisation and patient allocation will be fully centralized; we will use a central randomization service by the University of Turku. The randomization will be targeted on patients who have been hospitalized in Turku University Hospital and who are registered in the Hospital electronic medical records. The study will be individually randomized. Allocation will be computer generated. The participants will be randomly assigned in numbers via computerized assignment developed by the independent Trial Statistician and implemented by the Research Assistant who are trained for patient randomization and data collection.
Participants and the investigators enrolling the patient recruitment and randomization will not foresee assignment. Allocation will be masked to participants in two intervention groups; participants will be aware about the gaming intervention, but not which one is the experimental and which is the comparator. Investigators will not be masked to group allocation, while data analysts (outcome assessor) will be kept blinded to the allocation. As far as we are aware, there will be no contact between participants in different groups; participants are living in wide geographic area in the catchment area of Southwest Hospital District.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Processing speed and visuomotor tasks (Trail Making Test (TMT), WAIS-IV tasks)
Time Frame: follow-up on 3 months after the last intervention
Secondary Outcomes
- Attention and executive functions (Simon task)(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)
- Feasibility (adherence)(at baseline, during the intervention and after the intervention (in 8 weeks))
- Working memory (The Paced Auditory Serial Addition Test (PASAT), WAIS-IV)(follow-up on 3 months after the last intervention)
Investigators
Maritta Välimäki
Professor
University of Turku