Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01709-32 | Other Identifier | French Study Registration number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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%).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPE Group | Experimental | The experimental group (EXPE Group) will receive the Mila-Learn game. |
|
| CONT Group | Placebo Comparator | The control group (CONT Group) will receive the Mila-Placebo game. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental Group - Mila-Learn | Device | Eight tasks are used in Mila-Learn. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks after the start of training (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety criteria | Descriptive evaluation of any adverse events reported by the users. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David COHEN, Dr | Hôpital Pitié-Salpêtrière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre médical pluridisciplinaire CogCharonne | Paris | 75011 | France | |||
| Hôpital Pitié-Salpêtrière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40399331 | Derived | Descamps M, Grossard C, Pellerin H, Lechevalier C, Xavier J, Matos J, Vonthron F, Grosmaitre C, Habib M, Falissard B, Cohen D. Rhythm training improves word-reading in children with dyslexia. Sci Rep. 2025 May 21;15(1):17631. doi: 10.1038/s41598-025-02485-y. |
Not provided
Not provided
Not provided
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%).
Not provided
Not provided
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.
Evaluations will be carried out in a double-blind manner. The evaluators will not know to which group the children belong.
| control Group - Mila-Placebo |
| Device |
Eight tasks similar to Mila-Learn are used in the placebo group |
|
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. |
| 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). | 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. | 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. | 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. | 16 weeks after the start of training (T3) |
| Paris |
| 75013 |
| France |
| Centre Hospitalier Henri Laborit | Poitiers | 86000 | France |
| ID | Term |
|---|---|
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007806 | Language Disorders |
Not provided
Not provided