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App-delivered Therapy for Arabic Readers With Hemianopic Alexia

This study is currently recruiting participants.
Verified October 2017 by Jenny Crinion, University College London Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02482350
First Posted: June 26, 2015
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jenny Crinion, University College London Hospitals
  Purpose
Hemianopia refers to compromised vision in one half of the visual field, in either one or both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually caused by stroke or head injury. In order to read, participants have to move their eyes along a line of text three to four times per second. Such eye movements are called saccades. One makes use of peripheral visual information to the right (if reading from left to right, e.g., in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA patients are deprived of much of this information. Patients with HA require far more saccades, which slows their reading significantly and often prevents them from reading efficiently for work or pleasure. It follows that the reading ability of those who read left-to-right would be compromised more by right-sided HA, and in those who read right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of left-sided HA following stroke, in Arabic readers. An online treatment package has been developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment resources exist for the condition in right-to-left readers. The aim is to develop novel Arabic reading tests and rehabilitation material. The current project proposes to 1) translate this package into Arabic, 2) develop new Arabic reading test materials and 3) collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to develop an effective, novel, and empirically supported reading treatment package for Arabic readers with HA.

Condition Intervention
Stroke Behavioral: Reading Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: App-delivered Therapy for Arabic Readers With Hemianopic Alexia

Further study details as provided by Jenny Crinion, University College London Hospitals:

Primary Outcome Measures:
  • Improvement of reading speed [ Time Frame: 1 month ]
    Average total reading time will be calculated in words per minute (wpm) using descriptive statistics in IBM SPSS.


Secondary Outcome Measures:
  • Patients will report improvement in static text reading (newspapers, books, letters, etc.) as a function of quality activity of daily living. [ Time Frame: 2 months ]
    Participants will rate themselves on their ability to perform activities of daily living (ADLs) as a measure of their functional status in regards to their reading impairment.

  • Decrease in the number of fixations [ Time Frame: 1 month ]
    Fixation: maintaining visual gaze on a single location

  • Decrease in average fixation durations [ Time Frame: 1 month ]
    Fixation duration: length of fixational pauses during reading


Estimated Enrollment: 13
Study Start Date: July 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reading Training
A 3-months study design. There will be three distinct phases: base-line testing, reading training, and follow-up testing. T1-T7 indicate the 7 time-points at which we assess the following: reading speeds (word-per-minute), visual field test, visual search test, and Activities of Daily Living rating scale (T1: Day 1, Initial assessments; T2: Day 30, Pre-training assessments; T3: Day 60, During Reading Training (RT) after 5-hours; T4: During RT after 10-hours; T5: During RT after 15-hours; T6: During RT after 20-hour; T7: Day 90, Post-training assessments). Arabic reading patients with left-sided HA will receive app-delivered reading training in a single subject control based design for 1 month.
Behavioral: Reading Training
Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must:

    1. Have a right-sided hemispheric stroke, tumor or head injury
    2. Demonstrate a fixed left visual field homonymous deficit as defined by missing one or more stimuli on the automated visual field test developed for the application
    3. Have a baseline text reading speed of more than 40 words per minute
    4. Have been Arabic readers premorbidly

Exclusion Criteria:

  • Patients presenting:

    1. impaired speech production, speech comprehension or writing (to rule out those with central alexia)
    2. a premorbid history of neurological or psychiatric illness
    3. a baseline text reading speed of less than 40 words per minute (to exclude patients with pure alexia) will be excluded from the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482350


Contacts
Contact: Jennifer T Crinion, PhD +44 (0) 20 76791129 j.crinion@ucl.ac.uk
Contact: Sharifa M Alragam, MS Phone: + 44 (0)207 679 1186 sharifa.alragam.12@ucl.ac.uk

Locations
United Kingdom
The Wellington Hospital Recruiting
London, United Kingdom, NW8 9LE
Contact: Tamsin Reed, MSC    +44 (0) 207 483 5474    Tamsin.Reed@HCAHealthcare.co.uk   
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Jennifer T Crinion, PhD Institute of Cognitive Neuroscience
  More Information

Responsible Party: Jenny Crinion, Dr, University College London Hospitals
ClinicalTrials.gov Identifier: NCT02482350     History of Changes
Other Study ID Numbers: 150817
First Submitted: June 15, 2015
First Posted: June 26, 2015
Last Update Posted: October 25, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No