Single Arm Study Assessing the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Pediatric Participants With a Specific Learning Disability With Deficits in Reading
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Poppins
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Effect of Poppins Clinical on reading abilities (accuracy)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) and the International Classification of Diseases (ICD-11, 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;
- •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 (Securite Sociale)
- •Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.
排除标准
- •Subject has previously used Poppins Clinical or Mila-Learn;
- •Uncontrolled chronic illness (at investigator's discretion);
- •Previous epileptic seizures;
- •Participant actively participating in an interventional study that may affect results.
结局指标
主要结局
Effect of Poppins Clinical on reading abilities (accuracy)
时间窗: 8 weeks
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.
次要结局
- Reported adverse events(8 weeks)
- Effect of Poppins Clinical on reading abilities (speed)(8 weeks)
- Effect of Poppins Clinical on phonological skills(8 weeks)
- Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)(8 weeks)
- Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)(8 weeks)