An interventional study of experimental Group - Mila-Learn and control Group - Mila-Placebo in Learning Disorder, Specific, Learning Disabilities and Dyslexia, sponsored by Mila (bMotion Technologies). Completed at 3 sites in France. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Mila (bMotion Technologies) · Not applicable, Interventional, and Treatment
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%).
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's enrollment of 151 is above the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →This is the only study on the registry with Mila (bMotion Technologies) as lead sponsor.
Compared within Dyslexia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Specific Learning Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group (EXPE Group) will receive the Mila-Learn game.
Device: experimental Group - Mila-Learn
The control group (CONT Group) will receive the Mila-Placebo game.
Device: control Group - Mila-Placebo
Eight tasks are used in Mila-Learn.
Eight tasks similar to Mila-Learn are used in the placebo group
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)
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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