Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592911
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-09
Brief Title:
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 andor Written Expression Deficit vs a Control Group Receiving Conventional SOC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicentric Randomized Non-inferiority Study Examining the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Addition to Reduced Conventional Standard of Care on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading andor Written Expression Deficit Compared With a Control Group Receiving Conventional Standard of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPPINS-02
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 reduced conventional standard of care on the reading and writing skills of pediatric participants with a specific learning disability with reading andor 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 ie 1 speech and reading therapy sessions per week
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 ie 1 speech and reading therapy sessions per week
Detailed Description:
The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills
Poppins Clinical is a software as a medical device saMD that combines a musical and cognitive training program and a written language training program It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders SLD with reading deficit Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game
The POPPINS-02 study thus proposes to include two patient arms
The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy 1 session each 2 weeks
The control arm having only conventional speech and reading therapy 1 session per week during 12 weeks
A randomization list will be generated directing patients to the experimental or control arm and informing parents the patient and the speech and reading therapist after the first pre-test The investigator and his team will be blinded to the patient allocation group It is therefore a single-blind study since parents patients and speech and reading therapists will be aware of the randomization
In the experimental group patients will have access to training with Poppins Clinical for 5 sessions per week each session lasting approximately 20 minutes
Poppins Clinical is a software as a medical device saMD that combines a musical and cognitive training program and a written language training program It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders SLD with reading deficit Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game
The POPPINS-02 study thus proposes to include two patient arms
The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy 1 session each 2 weeks
The control arm having only conventional speech and reading therapy 1 session per week during 12 weeks
A randomization list will be generated directing patients to the experimental or control arm and informing parents the patient and the speech and reading therapist after the first pre-test The investigator and his team will be blinded to the patient allocation group It is therefore a single-blind study since parents patients and speech and reading therapists will be aware of the randomization
In the experimental group patients will have access to training with Poppins Clinical for 5 sessions per week each session lasting approximately 20 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None