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.
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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
151
Eight tasks are used in Mila-Learn.
Eight tasks similar to Mila-Learn are used in the placebo group
Centre médical pluridisciplinaire CogCharonne
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
Centre Hospitalier Henri Laborit
Poitiers, France
Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read
Absolute change in the number of pseudo-words correctly read by the children in the pseudo-word reading test, EVALEO 6-15, by Launay, Maeder, Roustit and Touzin, 2018.
Time frame: 8 weeks after the start of training (T2)
Safety criteria
Descriptive evaluation of any adverse events reported by the users.
Time frame: During the training phase, up to 8 weeks
Evaluation of phonological skills measured by the Battery of Analytical Test on Written Language (BALE) initial or final phoneme deletion test
This endpoint relates to the child's phonological skills at T2 compared to T1, evaluated using the BALE \[Battery of Analytical Tests on Written Language\] initial or final phoneme deletion test.
Time frame: 8 weeks after the start of training (T2)
Evaluation of speed and accuracy skills by the percentage of words correctly read in two minutes
This endpoint relates to reading skills in terms of speed and accuracy. The analysis will focus on the percentage of words correctly read in two minutes (EVAL2M, Evaleo 6-15).
Time frame: 8 weeks after the start of training (T2)
Evaluation of grapheme conversion skills in terms of speed and accuracy measured by two pseudo-word transcription tests
This endpoint relates to phoneme-grapheme correspondence skills, evaluated using two pseudo-word transcription tests.
Time frame: 8 weeks after the start of training (T2)
Evaluation of self-esteem measured by the Rosenberg Self-Esteem scale ; using a 4-point scale format ranging from strongly agree to strongly disagree
This endpoint relates to the evolution of the child's self-esteem measured by the Rosenberg Self-Esteem scale.
Time frame: 8 weeks after the start of training (T2)
Evaluation of the reading skills by the children in the pseudo-word reading test, EVALEO 6-15
The primary endpoint is the absolute change in the number of pseudo-words correctly read by the children in the pseudo-word reading test, EVALEO 6-15, by Launay, Maeder, Roustit and Touzin, 2018.
Time frame: 16 weeks after the start of training (T3)
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