Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading
Condition: Learning Disorder, Specific; Learning Disabilities; Dyslexia; Specific Learning Disorder, With Impairment in Reading
MeSH terms: Dyslexia; Learning Disabilities; Specific Learning Disorder
Study type: Interventional

Summary: 
      Mila-Learn-01 is a double-blind clinical study (meaning that neither the patient nor the
      doctor or his/her team will know which game the child has), which enables us to see the
      effect of a serious game on the child's reading skills.

      The patients who will participate in this research will receive, at random, one of the two
      serious study games, the experimental game (Mila-Learn) or the placebo game (Mila-Placebo).
      The tasks designed in the placebo game mirror those of Mila-Learn.

      Each game comprises eight tasks to be completed on a touchscreen tablet. Each session lasts
      25 minutes (±20%); five training sessions lasting 25 minutes are planned per week for eight
      weeks.
    

Detailed description: 
      The study consists of a randomised, double-blind clinical trial with a control group to
      evaluate the impact of the Mila-Learn game on children's skills. In order to maintain the
      blinding of the patient and his/her family, the study will be presented to them as evaluating
      the effect of serious games on a child's learning without explaining that the study is
      specifically interested in the Mila-Learn game, music and rhythm.

      Each child included in the study will be randomised:

        -  either to the experimental group (EXPE Group) and in this case will receive the
           Mila-Learn game

        -  or to the control group (CONT Group) and will receive the Mila-Placebo game.

      A randomisation list will be edited by the statistician. It will allow us to know whether the
      patient will be in the experimental arm or the control arm when sending out the tablets,
      depending on the chronological order of the inclusions, so that we can send the corresponding
      tablet to the patient.

      In each group, the children will follow the same training protocol consisting of five
      training sessions per week on the game corresponding to their group. Each game comprises 8
      tasks to be completed on a touchscreen tablet. Each session lasts 25 minutes (±20%).
    

Intervention name(s): experimental Group - Mila-Learn; control Group - Mila-Placebo
Intervention type(s): Device; Device
Intervention description(s): Eight tasks are used in Mila-Learn.; Eight tasks similar to Mila-Learn are used in the placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The experimental arm (EXPE Group) will receive the Mila-Learn game and the control arm (CONT Group) will receive the Mila-Placebo game.
In each group, the children will follow the same training protocol consisting of five training sessions per week on the game corresponding to their group. Each game comprises 8 tasks to be completed on a touchscreen tablet. Each session lasts 25 minutes (±20%).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment