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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

ConditionsLearning Disorder, SpecificLearning DisabilitySpecific Learning Disorder, With Impairment in ReadingDyslexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-11
SponsorPoppins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

306 Participants
are divided into 2 treatment groups
Group A: No intervention: CONTROL0 interventions
Group B: Experimental1 intervention

Trial outcomes

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

Time frame
12 weeks

Secondary outcomes

1

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

This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the 2-minute word reading test from EVALEO (EVAL2M), assessing the number of words read, 12 weeks after the last evaluation of the POPPINS-02 study.

Time frame
12 weeks
2

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

This endpoint evaluates the mid-term effect of the addition of Poppins Clinical on word reading skills in terms of speed and accuracy as assessed by a text reading test (Alouette) (speed and accuracy scores), 12 weeks after the last evaluation of the POPPINS-02 study.

Time frame
12 weeks
3

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

This endpoint examines the mid-term impact of adding Poppins Clinical on parents' stress levels, measured using the parenting stress index short form, 12 weeks after the last evaluation of the POPPINS-02 study.

Time frame
12 weeks
4

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).

This endpoint examines the mid-term impact of adding Poppins Clinical on parents' quality of life, measured using the EQ-5D-5L quality of life questionnaire, 12 weeks after the last evaluation of the POPPINS-02 study.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poppins

Lead sponsor

Lindus Health

Collaborator

Source ClinicalTrials.gov
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