Clinical Effectiveness of iReadMore for People With Alexia

NCT ID: NCT04849091

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Stroke Brain Injuries Aphasia Alexia Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

iReadMore

Intervention Type DEVICE

Digital Alexia Therapy

Interventions

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iReadMore

Digital Alexia Therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander P Leff, Professor

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Institute of Neurology, University College London

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Alexander P Leff, Professor

Role: CONTACT

02076791177

Thomas Langford, MSc

Role: CONTACT

07972267097

References

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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.

Reference Type BACKGROUND
PMID: 29912350 (View on PubMed)

Other Identifiers

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7609/001

Identifier Type: -

Identifier Source: org_study_id

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