Clinical Effectiveness of iReadMore for People With Alexia

Stroke Clinical Trial

Official title: Investigating the Clinical Effectiveness of iReadMore; a Digital Therapy for People With Alexia (Acquired Dyslexia)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

Further analyses will be conducted on alexia subtypes and the influence of therapy dose and intensity on the therapeutic outcomes.

Ethical approval for the iReadMore roll-out trial was obtained from the UCL Research Ethics Committee (ID: 7609/001). ;

Related Conditions & MeSH terms

• Alexia
• Aphasia
• Brain Injuries
• Dementia
• Dyslexia
• Stroke

• NCT number: NCT04849091
• Study type: Observational
• Source: University College, London
• Contact: Alexander P Leff, Professor
• Phone: 02076791177
• Email: a.leff@ucl.ac.uk
• Status: Recruiting
• Start date: March 15, 2021
• Completion date: April 2024