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

NCT05154721 | Completed

• 2 other identifiers: Mila-Learn-012021-A01709-32
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Safety criteria

  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

  8 weeks after the start of training (T2)

• Evaluation of speed and accuracy skills by the percentage of words correctly read in two minutes

  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

  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

  8 weeks after the start of training (T2)

Study Arms (2)

EXPE Group

EXPERIMENTAL

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

Device: experimental Group - Mila-Learn

CONT Group

PLACEBO COMPARATOR

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

Device: control Group - Mila-Placebo

Interventions

experimental Group - Mila-Learn DEVICE

Eight tasks are used in Mila-Learn.

EXPE Group

control Group - Mila-Placebo DEVICE

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

CONT Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poppins: lead

Study Sites (3)

Centre médical pluridisciplinaire CogCharonne

Paris, 75011, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Centre Hospitalier Henri Laborit

Poitiers, 86000, France

Location

Related Publications (1)

• Descamps M, Grossard C, Pellerin H, Lechevalier C, Xavier J, Matos J, Vonthron F, Grosmaitre C, Habib M, Falissard B, Cohen D. Rhythm training improves word-reading in children with dyslexia. Sci Rep. 2025 May 21;15(1):17631. doi: 10.1038/s41598-025-02485-y.

  PMID: 40399331 DERIVED

MeSH Terms

Conditions

Specific Learning Disorder; Learning Disabilities; Dyslexia

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Language Disorders

Study Officials

• David COHEN, Dr

  Hôpital Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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%).

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 13, 2021
• Study Start: October 1, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

FR (3)