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

Dyslexia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154721
• Other study ID #: Mila-Learn-01
• Secondary ID: 2021-A01709-32
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: April 3, 2023

Study information

• Verified date: July 2023
• Source: Mila (bMotion Technologies)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslexia
• Learning Disabilities
• Specific Learning Disorder

Intervention

Device:
• experimental Group - Mila-Learn
Eight tasks are used in Mila-Learn.
• control Group - Mila-Placebo
Eight tasks similar to Mila-Learn are used in the placebo group

Locations

Country	Name	City	State
France	Centre médical pluridisciplinaire CogCharonne	Paris
France	Hôpital Pitié-Salpêtrière	Paris
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Mila (bMotion Technologies)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Safety criteria	Descriptive evaluation of any adverse events reported by the users.	During the training phase, up to 8 weeks
Secondary	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.	8 weeks after the start of training (T2)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)