Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Bi-monthly Speech and Reading Therapy on Reading Writing Abilities of Pediatric Patients With SLD Reading VS Control Group

NCT06902610 | Recruiting

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

Brief Summary

Poppins-02-b is an observational follow-up study examining the medium-term effect on non-inferiority of the previous training with the digital medical device (DMN) Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing abilities of pediatrics patients with specific learning disorders involving reading and/or writing deficits compared to a control group that received weekly speech and reading therapy sessions. Poppins-02-b is an ancillary study to Poppins-02 and consists of monitoring patients who participated in Poppins-02 study.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the medium term 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 2-minutes word reading rest form EVALEO (EVAL2M), assessing the number of words correctly read, 12 weeks after the last evaluation of the POPPINS-02 study

  12 weeks

Secondary Outcomes (6)

• Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).

  12 weeks

• Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).

  12 weeks

• Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).

  12 weeks

• Description and comparison of the medium-term effect of adding Poppins Clinical on the quality of life of parents between the two groups (EXP/CONT) (non-inferiority).

  12 weeks

• Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).

  12 weeks

Study Arms (2)

No intervention: CONTROL

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

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 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)
• Sampling Method: Probability Sample

Study Population

According to the DSM-5-TR or ICD-11 Specific Learning Disability (SLD) or Developmental Learning Disability (DLD) is one of the most common neurodevelopmental disorders. It affects between 5% and 15% of schoolchildren. In particular, SLD is one of the most common neurodevelopmental disorders. It affects between 6% and 8% of schoolchildren. It is characterized by significant and persistent difficulties in the acquisition of academic skills, which may include reading, writing or arithmetic, although dyslexia is by far the most common type, accounting for 80% of SLD. SLD first manifests itself during the teaching of academic or occupational functioning. Children with SLD do not have associated intellectual retardation, overt brain damage or degenerative disorders. They are therefore likely to benefit most from remediation.

You may qualify if:

• Patient who has been enrolled in the POPPINS-02 study.
• Participation agreement from the patient as well as from the legal guardians, and commitment to follow the protocol.

You may not qualify if:

• Any pathology that, at the discretion of the investigator, may prevent the patient from participating in the study.
• Patient participating in an interventional study that could affect the results.

Sponsors & Collaborators

• Poppins: lead
• Lindus Health: collaborator

Study Sites (2)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Hôpital Henri Laborit

Poitiers, 86000, France

RECRUITING

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

Central Study Contacts

François Vonthron

CONTACT

0669515961; francois@poppins.io

Mélanie Descamps

CONTACT

melanie@poppins.io

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: June 20, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)