Investigating the Clinical Effectiveness of iReadMore; a Digital Therapy for People With Alexia (Acquired Dyslexia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Word Reading Test - Change in Reading Accuracy and Speed from baseline to 20 hours
研究概览
简要总结
iReadMore will provide an app-based therapy for people with pure or central alexia.
This study aims to test the clinical effectiveness of iReadMore for improving reading accuracy and speed in real world users of the therapy.
详细描述
iReadMore is a self-led therapy app for improving single word reading accuracy and speed in individuals with acquired reading impairments. iReadMore has been demonstrated to improve reading speed and accuracy in pure and central alexias (Woodhead et al., 2013, 2018). iReadMore therapy is not expected to improve reading for the remaining alexia subtypes.
iReadMore includes 590 of the most frequently written words from the SUBTLEX lexical database (Brysbaert and New, 2009). High frequency words were chosen to maximise the relevance (ecological utility) of the training to everyday life. The therapy mechanism relies on mass practice of cross-modal, paired associate learning (Holcomb and Anderson, 1993) based on the Triangle Model approach to reading. Untrained words will not be affected, and thus word reading improvements are not expected to generalise beyond trained items.
The therapy utilises gamification and is designed to be accessible in order to drive motivation and engagement for the user group. iReadMore is downloadable via the Google Play store on Android tablet devices. iReadMore is a CE-marked class 1 medical device that was developed by the Neurotherapeutics Group, University College London.
An online roll-out trial will be conducted to evaluate the clinical effectiveness of iReadMore with a study population of real world users. The therapy will be evaluated in a clinical population with a reading impairment of any acquired cause (such as stroke or brain injury). Participants will self-enrol in the study through the app, which has been co-designed to ensure accessibility to this user group.
A within-participant evaluation of trained versus untrained items will investigate the clinical effectiveness of the therapy for improving reading speed and accuracy. The primary outcomes are improvements in single word reading accuracy and speed. Interval testing will be conducted after every 5 hours of therapy. The secondary outcomes are self-reported Activities of Daily Living and a series of qualitative questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Diagnosed with stroke, dementia, brain injury or brain tumour
- •Diagnosed or self-diagnosed with impaired reading ability
- •Willing and able to give informed consent for participation in the study
排除标准
- •History of developmental reading or speech and language disability
结局指标
主要结局
Word Reading Test - Change in Reading Accuracy and Speed from baseline to 20 hours
时间窗: At baseline and after every 5 hours of therapy up to a maximum dose of 50 hours. Primary outcome is change from baseline to 20 hours.
Change in single word reading accuracy and speed will be assessed in a Word Reading Test (WRT) delivered in the app. At interval tests, the WRT will include both trained and untrained words to investigate the treatment-specific effects.
次要结局
- Participant-Reported Outcome Measures - Activities of Daily Living (ADL)(At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours)
- Participant-Reported Outcome Measures - Qualitative Questions(At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours)