Clinical Effectiveness of iReadMore for People With Alexia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Brain Injuries; Dementia; Aphasia; Alexia
• Intervention / Treatment: Device: iReadMore

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Alexander P Leff, Professor; Phone Number: 02076791177; Email: a.leff@ucl.ac.uk
• Study Contact Backup: Name: Thomas Langford, MSc; Phone Number: 07972267097; Email: thomas.langford.18@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3AR
    • Recruiting
    • Institute of Neurology, University College London
    • Sub-Investigator: Zoe Woodhead, PhD, MSc
    • Sub-Investigator: Jenny Crinion, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study involves real world users of the iReadMore therapy who have an acquired reading impairment. Users will self-register into the study via the app. In order to participate, users must have access to WiFi and an Android tablet device.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of developmental reading or speech and language disability

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iReadMore users; Participants will be iReadMore users who completed a baseline reading test between XX/XX/XXXX and XX/XX/XXXX, and who performed at least 5 hours of reading training and a second (interval) reading test. iReadMore users will self-register to participate in the study.	Device: iReadMore; Digital Alexia Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Word Reading Test - Change in Reading Accuracy and Speed 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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-Reported Outcome Measures - Activities of Daily Living (ADL)	Activities of Daily Living - Participants are asked to rate how easy they find completing a series of everyday tasks, including language and non-language related tasks. Responses are reported using a 7-point Likert scale from 0 to 6 denoting 'Very Easy' to 'Very Hard'.	At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours
Participant-Reported Outcome Measures - Qualitative Questions	Qualitative Questions - participants are also asked three open text questions on their experiences of the therapy and their reading abilities at that point in time.	At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Medical Research Council
• Investigators: Principal Investigator: Alexander P Leff, Professor, University College, London

Publications and helpful links

General Publications

• Woodhead ZVJ, Kerry SJ, Aguilar OM, Ong YH, Hogan JS, Pappa K, Leff AP, Crinion JT. Randomized trial of iReadMore word reading training and brain stimulation in central alexia. Brain. 2018 Jul 1;141(7):2127-2141. doi: 10.1093/brain/awy138.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Therapy; Dyslexia; Digital; Reading disorder; Alexia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Speech Disorders; Brain Injuries; Dyslexia; Aphasia
• Other Study ID Numbers: 7609/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No