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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Poppins Clinical.
- Кому может быть актуально
- Состояния в реестре: Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia. Базовые параметры: 7 лет — 11 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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.
Подробное описание
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:
1. Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions. 2. 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.
Access to the Poppins Clinical digital medical device will be offered to children in the two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study at the end of the experiment.
The investigator and his team will remain blind as to which groups will be assigned to the POPPINS-02 study.
Вмешательства
- Устройство Poppins Clinical
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.
Первичные конечные точки
- 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 [Срок оценки: 12 weeks]
Вторичные конечные точки (6)
- Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority). [Срок оценки: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority). [Срок оценки: 12 weeks]
- Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority). [Срок оценки: 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). [Срок оценки: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority). [Срок оценки: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority). [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Франция · 2 центра
- Hôpital Pitié-Salpêtrière — Paris
- Hôpital Henri Laborit — Poitiers
Идентификаторы
NCT: NCT06902610 · POPPINS-02-b