Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02482350 |
| Other study ID # |
150817 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
May 2023 |
| Source |
University College London Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
