NCT05154721

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Poppins · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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%).

Conditions

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

Interventions

Type	Name	Description
DEVICE	experimental Group - Mila-Learn	Eight tasks are used in Mila-Learn.
DEVICE	control Group - Mila-Placebo	Eight tasks similar to Mila-Learn are used in the placebo group

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2021-12-13
• Last updated: 2023-07-18

Locations

3 sites across 1 country: France