Clinical Effectiveness of iReadMore for People With Alexia
NCT ID: NCT04849091
Last Updated: 2023-05-10
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2021-03-15
2024-04-30
Brief Summary
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This study aims to test the clinical effectiveness of iReadMore for improving reading accuracy and speed in real world users of the therapy.
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Detailed Description
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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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Study Design
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COHORT
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
Digital Alexia Therapy
Interventions
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iReadMore
Digital Alexia Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
University College, London
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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.
Other Identifiers
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7609/001
Identifier Type: -
Identifier Source: org_study_id
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