Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading

bMotion Technologies

Status: Completed

Conditions: Learning Disabilities; Specific Learning Disorder, With Impairment in Reading; Dyslexia; Learning Disorder, Specific

Treatments: Device: control Group - Mila-Placebo; Device: experimental Group - Mila-Learn

Study type: Interventional

Funder types: Industry

Identifiers

NCT05154721

Mila-Learn-01

2021-A01709-32 (Other Identifier)

Details and patient eligibility

About

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.

Full 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%).

Enrollment: 151 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 2 patient groups, including a placebo group

EXPE Group

Experimental group

Description:

The experimental group (EXPE Group) will receive the Mila-Learn game.

Treatment:

Device: experimental Group - Mila-Learn

CONT Group

Placebo Comparator group

Description:

The control group (CONT Group) will receive the Mila-Placebo game.

Treatment:

Device: control Group - Mila-Placebo