Examining the Effect of a Digital MD for Cognitive and Musical Training + Reduced Conventional SOC on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit vs a Control Group Receiving Conventional SOC.

NCT06592911 | Completed

• 1 other identifier: POPPINS-02
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

Brief Summary

Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing skills of pediatric participants with a specific learning disability with reading and/or written expression deficit. Participants will be assigned randomly either to an experimental group that will use the medical device in combination with reduced speech and reading therapy sessions (1 session each 2 weeks) or to the control group receiving conventional standard of care, i.e. 1 speech and reading therapy sessions per week.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.

  This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of correctly read words.

  12 weeks

Secondary Outcomes (8)

• Secondary safety objective

  12 weeks

• Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)

  12 weeks

• Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)

  12 weeks

• Secondary objective 3: description and evaluation of the coast associated to children's treatment

  12 weeks

• Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)

  12 weeks

Study Arms (2)

CONTROL

NO INTERVENTION

1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical

EXPERIMENTAL

EXPERIMENTAL

Reduced speech and reading therapy sessions (1 session every 2 weeks) and use of the medical device Poppins Clinical

Device: Poppins Clinical

Interventions

Poppins Clinical DEVICE

Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.

EXPERIMENTAL

Eligibility Criteria

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

You may qualify if:

• Diagnosis of SLD with reading deficit, based on a speech-language assessment. SLD with reading deficit is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, 2022). The speech-language assessment should consist of at least three reading and/or transcription tests with a SD (standard deviation) of at least - 1.4 or a result below the 20th percentile or two reading and/or transcription tests with a SD of at least - 2 SD or a results below the 10th percentile;
• Subject aged between 7 and 11, enrolled from CE1 to CM2;
• Subject receiving speech and reading therapy for less than 2 years, receiving speech and reading therapy for written language for less than 2 years, with a maximum treatment frequency of one session per week, either for at least 3 months for children followed for more than 3 months, or for the duration of the treatment for children followed for less than 3 months.;
• French mother tongue or French bilingualism at home and more than 3 years schooling in France;
• Tablet or smartphone available at home;
• Subject affiliated to the French National Insurance (Sécurité Sociale);
• Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.

You may not qualify if:

• Subject has previously used Poppins Clinical or a previous version (Mila-Learn);
• Unstabilized chronic illness (at investigator's discretion);
• Participants with autism spectrum disorders or documented intellectual disabilities;
• Vision or Hearing difficulties preventing the use of the tablet or smartphone;
• Any condition that, in the opinion of the investigator, may prevent the patient from participating in the trial
• Participant actively participating in an interventional study that may affect results.
• Concurrent participation of any other family member in the same clinical trial

Sponsors & Collaborators

• Poppins: lead
• Lindus Health: collaborator

Study Sites (2)

Hôpital Pitié-Salpêtrière, Paris, Paris 75013

Paris, 75013, France

Location

Hôpital Henri Laborit Poitiers, 86000

Poitiers, 86000, France

Location

Related Publications (1)

• Grossard C, Descamps M, Cadoni S, Pellerin H, Vonthron F, Xavier J, Falissard B, Cohen D. Assessing the Noninferiority of a Rhythm and Language Training Serious Game Combined With Speech Therapy Versus Speech Therapy Care for Children With Dyslexia: Protocol for an Investigator-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 3;14:e71326. doi: 10.2196/71326.

  PMID: 40179385 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 Design

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

Model Details: Multicentric randomized non-inferiority study

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: September 19, 2024
• Study Start: December 20, 2024
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)