Clinical Effectiveness of iReadMore for People With Alexia

NCT04849091 | Unknown

• 1 other identifier: 7609/001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Brain Injuries; Aphasia; Alexia; Dementia

Keywords

Digital; Therapy; Reading disorder; Alexia; Dyslexia; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Participant-Reported Outcome Measures - Activities of Daily Living (ADL)

  At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours

• Participant-Reported Outcome Measures - Qualitative Questions

  At baseline and after every 10 hours of therapy up to a maximum dose of 50 hours

Study Arms (1)

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

Interventions

iReadMore DEVICE

Digital Alexia Therapy

iReadMore users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of developmental reading or speech and language disability

Sponsors & Collaborators

• University College, London: lead
• Medical Research Council: collaborator

Study Sites (1)

Institute of Neurology, University College London

London, WC1N 3AR, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 29912350 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries; Aphasia; Dyslexia; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Specific Learning Disorder; Learning Disabilities; Neurodevelopmental Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Alexander P Leff, Professor

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander P Leff, Professor

CONTACT

02076791177; a.leff@ucl.ac.uk

Thomas Langford, MSc

CONTACT

07972267097; thomas.langford.18@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: March 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)