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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00432-45 | Other Identifier | ANSM |
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The goal of this clinical trial is to assess the effect on reading skills of the digital medical device Poppins Clinical for cognitive and musical training in pediatric participants (ages 7-11) with a specific learning disability with reading deficit. The main objective of the study is to assess the evolution in reading skills through a word reading task before and after the intervention.
Participants will be asked to train with the digital medical device Poppins Clinical 5 times per week for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Poppins Clinical on reading abilities (accuracy) | Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of reading accuracy) of participants using a word reading task and measuring the number of correctly read words. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reported adverse events | To evaluate safety, reported adverse events during the 8 weeks follow-up phase will be evaluated. | 8 weeks |
| Effect of Poppins Clinical on reading abilities (speed) | Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of speed) of participants using a word reading task and measuring the number of read words. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cohen | Hôpital Pitié-Salpêtrière, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40750096 | Derived | Grossard C, Descamps M, Pellerin H, Vonthron F, Cohen D. Children's Improvement After Language and Rhythm Training With the Digital Medical Device Poppins for Dyslexia: Single-Arm Intervention Study. JMIR Serious Games. 2025 Aug 1;13:e76435. doi: 10.2196/76435. |
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| 8 weeks |
| Effect of Poppins Clinical on phonological skills | Evaluate the effect of 8 weeks of training with Poppins Clinical on phonological skills of participants using the BALE test. | 8 weeks |
| Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy) | Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading accuracy) using a word reading task and measuring the number of correctly read words. | 8 weeks |
| Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed) | Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading speed) using a word reading task and measuring the number of read words. | 8 weeks |
| ID | Term |
|---|---|
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007806 | Language Disorders |
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