Learning Disorder, SpecificNCT05154721
Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading
A study testing experimental Group - Mila-Learn in people with Learning Disorder, Specific and Learning Disabilities, run by Poppins at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Learning Disorder, Specific, Learning Disabilities, Dyslexia
- What is being tested?
- experimental Group - Mila-Learn
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Oct 2021to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Centre médical pluridisciplinaire CogCharonne
Paris, 75011
Hôpital Pitié-Salpêtrière
Paris, 75013
Centre Hospitalier Henri Laborit
Poitiers, 86000
About this study
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)
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.
Read the 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
- Being tested
- experimental Group - Mila-Learn, control Group - Mila-Placebo
- Medical subject headings
- Specific Learning Disorder, Learning Disabilities, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental Group - Mila-LearnDevice
Eight tasks are used in Mila-Learn.
control Group - Mila-PlaceboDevice
Eight tasks similar to Mila-Learn are used in the placebo group
| Study group | Role | What they receive |
|---|---|---|
| EXPE Group | Experimental | The experimental group (EXPE Group) will receive the Mila-Learn game. Receives: Device: experimental Group - Mila-Learn |
| CONT Group | Placebo comparator | The control group (CONT Group) will receive the Mila-Placebo game. Receives: Device: control Group - Mila-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks after the start of training (T2)
Secondary outcomes (6)
Safety criteria
Descriptive evaluation of any adverse events reported by the users.
Measured: 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
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.
Measured: 8 weeks after the start of training (T2)
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).
Measured: 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
This endpoint relates to phoneme-grapheme correspondence skills, evaluated using two pseudo-word transcription tests.
Measured: 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
This endpoint relates to the evolution of the child's self-esteem measured by the Rosenberg Self-Esteem scale.
Measured: 8 weeks after the start of training (T2)
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.
Measured: 16 weeks after the start of training (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Oct 2021
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning Disorder, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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%).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poppins
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David COHEN, Dr, Principal investigator, Hôpital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154721
- Sponsor's protocol ID
- Mila-Learn-01
- Other IDs
- 2021-A01709-32
- Status last verified
- Jul 2023
- First submitted
- 23 Nov 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40399331
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05154721
- Acronym / sponsor ID
- Mila-Learn-01
- Conditions
- Learning Disorder, Specific, Learning Disabilities, Dyslexia, Specific Learning Disorder, With Impairment in Reading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- PoppinsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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%).
| Arm | Type | Receives |
|---|---|---|
| EXPE Group | Experimental | Device: experimental Group - Mila-LearnThe experimental group (EXPE Group) will receive the Mila-Learn game. |
| CONT Group | Placebo comparator | Device: control Group - Mila-PlaceboThe control group (CONT Group) will receive the Mila-Placebo game. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental Group - Mila-LearnEight tasks are used in Mila-Learn. | Device | EXPE Group |
| control Group - Mila-PlaceboEight tasks similar to Mila-Learn are used in the placebo group | Device | CONT Group |
Primary outcome
Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read
Time frame: 8 weeks after the start of training (T2)
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.
6 secondary outcomes
Safety criteria
Time frame: 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
Time frame: 8 weeks after the start of training (T2)
Evaluation of speed and accuracy skills by the percentage of words correctly read in two minutes
Time frame: 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
Time frame: 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
Time frame: 8 weeks after the start of training (T2)
Evaluation of the reading skills by the children in the pseudo-word reading test, EVALEO 6-15
Time frame: 16 weeks after the start of training (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 40399331Descamps 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David COHEN, Dr principal investigator
Hôpital Pitié-Salpêtrière
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental Group - Mila-Learn in people with Learning Disorder, Specific and Learning Disabilities, run by Poppins at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of musical and rhythmic training measured by the number of pseudo-words correctly read (time frame: 8 weeks after the start of training (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.