Clinical trial NCT05154721: Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading
Official title: Effect of Music and Rhythm Training Delivered Through a Serious Game on the Reading Skills of Children With a Specific Learning Disorder Impacting Reading, a Multicentric Double-blind and Placebo-controlled Study (Mila-Learn-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Disorder, Specific
Learning Disabilities
Dyslexia
Specific Learning Disorder, With Impairment in Reading
Lead sponsor: Mila (bMotion Technologies)
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 151
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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%).
Primary purpose: TREATMENT

Brief 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%).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Specific Learning Disorder with Impairment in Reading through speech therapy testing and confirmed by a doctor. Specific Learning Disorder with Impairment in Reading is defined in the diagnostic and statistical manual of mental disorders (DSM-5).
* Patient 7-11 years old, schooled from the second year of primary school (CE1) to the last year of primary school (CM2).
* Native Speaker of French OR French bilingualism at home AND Child schooled in France for more than 3 years
* Person affiliated with a social security scheme.
* Participant's agreement to participate and the agreement of the holders of parental authority and commitment to follow the protocol.

Exclusion Criteria:

* Patient undergoing or having undergone speech therapy or psychomotor therapy during the 12 months before the start of the study.
* Patient who has previously used Mila-Learn.
* Uncontrolled, chronic illness, at the investigator's discretion.
* Participation in another interventional study that could impact the analysis of the study.

Primary outcomes:
measure: Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read
timeFrame: 8 weeks after the start of training (T2)
Secondary outcomes:
measure: Safety criteria
timeFrame: During the training phase, up to 8 weeks
measure: Evaluation of phonological skills measured by the Battery of Analytical Test on Written Language (BALE) initial or final phoneme deletion test
timeFrame: 8 weeks after the start of training (T2)
measure: Evaluation of speed and accuracy skills by the percentage of words correctly read in two minutes
timeFrame: 8 weeks after the start of training (T2)
measure: Evaluation of grapheme conversion skills in terms of speed and accuracy measured by two pseudo-word transcription tests
timeFrame: 8 weeks after the start of training (T2)
measure: Evaluation of self-esteem measured by the Rosenberg Self-Esteem scale ; using a 4-point scale format ranging from strongly agree to strongly disagree
timeFrame: 8 weeks after the start of training (T2)
measure: Evaluation of the reading skills by the children in the pseudo-word reading test, EVALEO 6-15
timeFrame: 16 weeks after the start of training (T3)
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre médical pluridisciplinaire CogCharonne
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Hôpital Pitié-Salpêtrière
name: David COHEN, Dr
role: PRINCIPAL_INVESTIGATOR
References: