StrokeNCT04849091
Clinical Effectiveness of iReadMore for People With Alexia
An observational study of Stroke and Brain Injuries, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injuries, Aphasia
- What is being tested?
- iReadMore
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2021to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of developmental reading or speech and language disability
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Neurology, University College London
London, WC1N 3AR
Zoe Woodhead, PhD, MSc
Jenny Crinion, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Stroke, Brain Injuries, Aphasia, Alexia, Dementia
- Being tested
- iReadMore
- Keywords
- Digital, Therapy, Reading disorder, Alexia, Dyslexia, Rehabilitation
- Medical subject headings
- Stroke, Brain Injuries, Aphasia, Dyslexia, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iReadMoreDevice
Digital Alexia Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iReadMore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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'.
Measured: 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.
Measured: At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start15 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Alexander P Leff, Professor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849091
- Sponsor's protocol ID
- 7609/001
- Status last verified
- May 2023
- First submitted
- 7 Apr 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29912350
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Effectiveness of iReadMore; a Digital Therapy for People With Alexia (Acquired Dyslexia)
- ClinicalTrials.gov ID
- NCT04849091
- Acronym / sponsor ID
- 7609/001
- Conditions
- Stroke, Brain Injuries, Aphasia, Alexia, Dementia
- Keywords
- Digital, Therapy, Reading disorder, Alexia, Dyslexia, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iReadMore users | – | Device: iReadMoreParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of developmental reading or speech and language disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iReadMoreDigital Alexia Therapy | Device | iReadMore users |
Primary outcome
Word Reading Test - Change in Reading Accuracy and Speed from baseline to 20 hours
Time frame: 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.
2 secondary outcomes
Participant-Reported Outcome Measures - Activities of Daily Living (ADL)
Time frame: At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours
Participant-Reported Outcome Measures - Qualitative Questions
Time frame: At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 29912350Woodhead 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander P Leff, Professor principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Brain Injuries, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander P Leff, Professor (02076791177, a.leff@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Reading Test - Change in Reading Accuracy and Speed from baseline to 20 hours (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.