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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02425527 |
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Date of registration:
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20/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Digital Gaming for Persons With Traumatic Brain Injury
PLAY |
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Scientific title:
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Digital Gaming Used to Improve the Cognitive Functioning and Well-being of People With Traumatic Brain Injury: a Feasibility Study |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02425527 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Aki Koponen, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Economics, Centre of Collaborative Research, University of Turku |
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Name:
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Maritta Välimäki, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, Department of Nursing Science, University of Turku |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Brain Injuries, Traumatic
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Traumatic Brain Injury
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TBI (Traumatic Brain Injury)
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Brain Injuries
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Injury, Brain, Traumatic
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Intervention(s)
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Behavioral: The entertaining gaming
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Behavioral: The rehabilitation gaming
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Primary Outcome(s)
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Processing speed and visuomotor tasks (Trail Making Test (TMT), WAIS-IV tasks)
[Time Frame: follow-up on 3 months after the last intervention]
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Secondary Outcome(s)
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Depression (Patient Health Questionnaire (PHQ-9)
[Time Frame: follow-up on 3 months after the last intervention]
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Working memory (The Paced Auditory Serial Addition Test (PASAT), WAIS-IV)
[Time Frame: follow-up on 3 months after the last intervention]
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Attention and executive functions (Simon task)
[Time Frame: follow-up on 3 months after the last intervention]
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Feasibility (adherence)
[Time Frame: at baseline, during the intervention and after the intervention (in 8 weeks)]
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Executive functions (The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
[Time Frame: follow-up on 3 months after the last intervention]
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Self-efficacy (General Self-efficacy Scale (GSC)
[Time Frame: follow-up on 3 months after the last intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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