Observational Follow-up Study Examining the Medium-term Effect on Non-inferiority of the Previous Training With the Digital Medical Device (DMD) Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Abilities of Pediatric Patients With Specific Learning Disorders Involving Reading and/or Writing Deficits (SLD Reading) Compared to a Control Group Receiving Weekly Speech and Reading Therapy Sessions (POPPINS-02-b, Ancillary Study to POPPINS-02)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Poppins
- 入组人数
- 306
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
The POPPINS-02-b follow-up study consists in following up patients who took part in the POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group designed to assess the effect of adding the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions on the skills of patients with reading disorders. Patients included in the original POPPINS-02 study were randomized into one of two groups:
- Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions.
- Control group (CONT group): will receive weekly speech and reading therapy sessions.
In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a preliminary evaluation (T1) and a final evaluation (T2) after this period.
All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will return to their usual speech therapy management with the frequency planned before their participation in POPPINS-02. During this follow-up phase, patients in both groups will not have access to the Poppins Clinical application. At the end of the 12-week follow-up period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and exploratory endpoints.
A questionnaire will also be submitted to parents and speech therapists caring for the children during T3 in order to collect information on the dates of speech therapy sessions during this follow-up period, and to benefit from their perspective on the medium-term effect of the study protocol on speech therapy follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects must meet all of the following inclusion criteria:
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Poppins Clinical (Device)
结局指标
主要结局
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
时间窗: 12 weeks
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
次要结局
- Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).(12 weeks)
- Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).(12 weeks)
- Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (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 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)
- Evaluate the medium-term effect of adding Poppins Clinical on metaphonological 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 text comprehension (non-inferiority).(12 weeks)