App-delivered Therapy for Arabic Readers With Hemianopic Alexia
Condition: Stroke
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Background

      Purpose and Experimental Design Reading a line of text is usually achieved by planning a
      series of saccades, which allow the eyes to jump from one word to another (reading
      scan-path). Arabic readers use peripheral visual information to the left of the word in order
      to plan their reading eye movements. Patients with HA are deprived of this information and
      compensate by creating inefficient reading scan-paths with many additional saccades,
      resulting in accurate but slow reading. Some patients abandon reading altogether, or lose
      their jobs because they cannot read fast enough.

      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.

      This study proposes to adapt these techniques for scrolling Arabic text, and to test them in
      Arabic-reading patients with left-sided HA. Rehabilitation material will be made available on
      the Internet (via an iPhone and/or iPad Application ('app')) for suitable subjects, in order
      to investigate whether patients benefit from using them outside of controlled trial
      conditions. During pre- and post-therapeutic intervention the investigators will record the
      following: reading speeds, visual field test scores, visual search test scores,
      eye-movements, and Activities of Daily Living scores. Length of time for which patients
      access rehabilitation material, will also be recorded.

      This study will help determine the efficacy of Internet-based behavioural rehabilitation. It
      will also provide information as to: 1) how much improvement may be gained through this
      program, and 2) how much practice patients will likely require in order to improve their
      reading significantly.

      Objectives

      This study proposes:

        1. Adapt and test reading rehabilitation techniques in patients with left-sided HA, using
           scrolling Arabic text;

        2. Investigate whether patients benefit from using such material outside of controlled
           trial conditions.

      Hypothesis

        1. Patients will report a significant improvement in the speed at which they read static
           text (newspaper, books, letters, etc.) as a function of quality activity of daily
           living.

        2. Patients will decrease the number of fixations (both progressive and regressive type
           saccades) when reading static text.

      Methods Thirteen Arabic-reading patients with left-sided homonymous HA following stroke will
      be studied over a period of three months. A single-subject baseline control design will be
      employed. There will be a treatment-free interval before and after reading therapy. Baseline
      assessments of visual fields, eye movement performance during text reading, text reading
      speed, and visual search performance will be carried out pre-intervention. Behavioural
      assessments will be repeated immediately following every five hours of therapy, and during
      follow-up. Patients will determine how long to wait between testing points, as they will
      differ in reading speeds.

      Patients meeting the study criteria will be identified through Dr. Alex Leff's Alexia clinic
      at the National Hospital for Neurology and Neurosurgery, University College London Hospital
      (UCLH), as well as through formal collaboration with the neuropsychology department at
      Wellington Hospital. In addition, patients will be given the option to join the study when
      downloading the reading therapy app from the Apple iTunes store. An online consent form will
      be included in the registration. The aim is to recruit at least thirteen patients to this
      study over the following three years.

      Thirteen healthy age-matched Arabic reading controls will be recruited from a variety of
      sources, including relatives and friends of patients. Controls will undergo the same
      assessment as patients, but will be assessed only once. They will not undergo the reading
      therapy.

      Consent Initially, both the information sheet and consent forms will be delivered in hard
      copy (written in both Arabic and English). When the application has been developed, pilot
      study will be conducted. Participants will complete online consent forms, and will be
      required to click certain key boxes to confirm that they have read or listened to, and
      understood, the information.

      Risks, Burdens, and Benefits:

      Benefits. App-delivered reading therapy has never before been available as a rehabilitation
      package for Arabic reading patients with HA. The app may be used as stand-alone self-help
      reading therapy, or as part of formal speech-language therapy. Additional benefits include
      real-time activity monitoring, tracking of treatment progress, personalised feedback and
      motivation support, portability and flexibility of use, and the potential to improve with
      practice.

      Risks/Burdens. This will be the first study in patients with left-sided HA using scrolling
      Arabic text. Thus there is little literature to guide the study. In order to maximize its
      potential, the investigators will adapt the established English-reading treatment approach
      used for patients with right-sided HA. There is no way of predicting how many patients will
      use the application. Some participants may not meet the study criteria. In addition, the
      patients themselves will manage their use of the application. There is therefore an inherent
      risk of their not accessing the rehabilitation materials for the required period of time, and
      not entering the data correctly.

      Data Collection

      Participants will be required to enter the following data in order to gain full access to the
      rehabilitation material:

      Data to be collected on App-based patients

        1. A unique login, created by themselves. (This does not have to be their real name.) This
           will ensure that each time they access the application; their data is collected under
           their name.

        2. Their email address (optional), for use only if they forget their login details.

        3. The extent and side of their hemianopia. If they have not had this test performed by
           their own doctor or optometrist, a section of this application provides self-testing.

        4. A test of their reading speed. This will be self-administered. Participants will time
           themselves (a timer on the application will be activated by the touch screen) reading a
           standard text aloud. Their text reading speed will be calculated and feedback to them.
           Participants may check or recheck this at various times during the study.

        5. A test of their performance on a visual search test. This will be self-administered.
           Participants will be tested on their accuracy and speed when finding objects on a
           section of the application. Their performance scores will be calculated and feedback to
           them. Participants may check or recheck this at various times during the study.

        6. 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.
           Their scores will be calculated but not feedback to them.

      Other optional fields, which may prove useful in data analysis if enough subjects complete
      them will include:

        1. The cause of their hemianopia. (This is usually stroke or head injury, but a free text
           option will be provided.)

        2. How much reading they can manage with their hemianopia

        3. Whether their hemianopia has caused them to change or loose their employment

      Participants will access the app and enter all personal data themselves. The only data we
      will collect that is not directly controlled by the participants is the amount of time they
      access the rehabilitation materials and their logon identification. The latter will ensure
      that the same participant is not logging on to the application under multiple names.

      Rehabilitation materials used in the app-based reading training The rehabilitation materials
      will consist simply of chapters of text, which scroll from left-to-right: that is, from the
      blind visual field of the participants to their normal visual field. The texts will be
      sourced from books out of copyright, freely available on the Internet. The aim is to provide
      streaming text from other websites, such as news, current affairs etc. The participant may
      control the speed at which the text scrolls. Participants will be advised to practice the
      reading therapy on most days and to aim for 20 to 40 minutes per day. They will also be asked
      to test their reading speeds every time they complete five hours of rehabilitation. Subjects
      will be prompted to check their reading speeds after every five hours of exposure to therapy.
      If they choose not to record any of this data, their access to the rehabilitation materials
      will not be affected.

      Data to be collected on Face-to-Face patients Patients with HA adopt an inefficient reading
      strategy to compensate for their visual impairment on the hemianopic side. Therefore, we want
      to compare the patients' reading scan-paths to those generated by healthy controls reading
      the same static passages. We will be recording eye movements of participants as they read 10
      passages using an eye-tracking device. A between groups statistical analysis will be
      performed.
    

Intervention name(s): Reading Training
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment