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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-04-03

Brief Summary

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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.

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Detailed Description

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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%).

Conditions

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Learning Disorder, Specific Learning Disabilities Dyslexia Specific Learning Disorder, With Impairment in Reading

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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EXPE Group

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

Group Type EXPERIMENTAL

experimental Group - Mila-Learn

Intervention Type DEVICE

Eight tasks are used in Mila-Learn.

CONT Group

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

Group Type PLACEBO_COMPARATOR

control Group - Mila-Placebo

Intervention Type DEVICE

Eight tasks similar to Mila-Learn are used in the placebo group

Interventions

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experimental Group - Mila-Learn

Eight tasks are used in Mila-Learn.

Intervention Type DEVICE

control Group - Mila-Placebo

Eight tasks similar to Mila-Learn are used in the placebo group

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No