Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies
Condition: Stroke; Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6
      months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of
      competitive versus non-competitive attentional training. Competitive training will include
      fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations
      and fifteen 1-hour sessions of competitive attentional games designed for this purpose using
      a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED
      array to facilitate multi-touch experience embedded in a conventional table). Progress will
      be evaluated by pre and post measurement of attentional neuropsychological tests, subjective
      reports of global attention, usability and motivational scales. Our hypothesis is that
      competitive training is more effective in improving attention than conventional training in
      the chronic phase after acquired brain injury.
    

Detailed description: 
      Participants: Sixty 18-75 years-old patients with acquired brain injury, will be randomly
      assigned to 30 sessions of competitive versus non-competitive cognitive attentional training
      (see inclusion-exclusion criteria). Material and Methods: Randomized clinical trial comparing
      two different attentional training strategies. Attentional measures, usability data and
      caregiver/family perception of change, will be compared after completing both conditions.
      Competitive training will include a new computer based training program that involve using
      attentional skills under different competitive scenarios. Attentional exercises were designed
      according to the instructions of two experts neuropsychologists and included game-based
      situations simulating different olympic disciplines.Neuropsychological protocol: An
      assessment before the beginning of the intervention and pos-treatment will be done by a
      trained blinded neuropsychologist using measures of selective, sustained, divided and
      alternating attention (see primary outcome measures). Usability and Motivation: It is
      well-known that game-based cognitive exercises can increase motivation to treatment which in
      turn can increase learning strategies and improve outcomes after rehabilitation processes.
      Competitive tasks can also improve the effort and interest of the players and the intensity
      of the task through increasing motivation to win, get a reward and beat the others. Since
      motivation was an important element of our research, we assessed this capacity at the end of
      the treatment with the Intrinsic Motivation Scale. Also, the revised Competitiveness Index
      was used to measure the subject's preference for competitive situations. Finally, usability
      was considered a secondary outcome of our study since most of the games employed here were
      designed to be played in a new virtual reality system which was build to facilitate
      competitive strategies among 2-4 players (see secondary outcomes). Sample Size Calculation:
      There was any previous study that used the design proposed in this investigation. Considering
      a reduction bigger of 20% on the Hit-Reaction Time of the CPT-II scores in the active group
      intervention, sample size in both groups of 27 participants and standard-deviation in the
      magnitude of half of the medium score in each group (moderate variability), the study will be
      able to detect a moderate effect size (ES = 0,4). Calculating a sample loss of 10% each
      group, we define a sample size per group of 30 individuals. Statistical methods Statistical
      analyses will be performed with Statistical Package for the Social Sciences (SPSS) 12.0. The
      univariate analyses will be performed with the t student test / Mann-Whitney to continuous
      variables or Chi-Square test (X²) / Fischer test to categorical variables. The effective of
      the intervention over time will be assess through analyses of mixed models (repeated measures
      ANOVA).
    

Intervention name(s): Competitive training; Non-Competitive Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min; 30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Attention; Competitive; Training