Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05028647 |
| Other study ID # |
823 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
IRCCS Eugenio Medea |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Virtual reality (VR) and augmented reality (AR) are gaining importance in the rehabilitation
programs for learning disabilities. The project will test tolerability and efficacy of a
VR/AR specially developed tool to improve reading abilities of adolescents with dyslexia aged
10-16
Description:
Dyslexia is the most common form of learning difficulty, with a prevalence of at least 10
percent, putting more than 700 million children and adults worldwide at risk of life-long
illiteracy and social exclusion (Springer-Charolles, Siegel, Jiménez & Ziegler, 2011). In the
EU context 2,500,000 dyslexic school children in the EU have a specific disorder in learning
to read and spell (dyslexia). Dyslexia is one of the development disorders that has been most
discussed and researched, however, intervention through technology is relatively recent. The
wide repertoire of manifestations and problems associated with dyslexia can be an obstacle to
access to a standardized curriculum. It can also make it difficult to access the training or
mobility programs provided by the European Union.
The FORDYS-VAR main objective is to provide an opportunity to improve the learning of people
with dyslexia through technology, specifically Virtual Reality (VR) and Augmented Reality
(AR). Introducing these technologies in the process of evaluation and intervention can become
a key element to improve the effectiveness of learning and the improvement of their training
experience.
Working with the AR and the VR provides people with dyslexia a safe and controlled
environment, improves their motivation, contributes to generate high levels of interaction.
Another advantage that we must emphasize is that you get an immediate feedback through
technology, which contributes to improve visual skills and memory.
The transnationally approach of this project is needed because dyslexia occurs in all
languages. Also we must consider that depending on the language, dyslexia will manifest
itself in different ways. Target groups: (1) Children with dyslexia that will be the
end-users of the materials developed; (2) Professionals involving in providing formal and
non-formal treatment of dyslexia: Therapist, educators; (3) Families of dyslexic children.
The FORDYS-VAR project aims to be a reference in the definitive treatment of dyslexia, The
creation of VR and AR materials for improvement the treatment of dyslexia in school children
will be the final goal of the project. As mentioned before, "the definitive treatment" has
not yet been found, but what is known is that the best treatments or the most effective
include aspects such as intensive sessions, explicit instructions, individual or small group
work and special attention must be paid to the phonological awareness and compensation
strategies. It has also been seen that in many cases the adherence to treatments is not very
high since they tend to be very repetitive and not very stimulating (children end up being
bored). Currently, the applied treatments are multisensory structured language education
(MSLE). They are usually multisensory, highly structured and sequential. For this reason, VR
and AR fit perfectly into improving the efficacy of these treatments.
- VR and AR will be immersive and interactive. That is, not only glasses will be used to
see, but also proposed tools will promote the interaction with gestural recognition so
that the experience is more immersive and, therefore, more active (this will impact in
the interaction with gestural recognition so that the experience is more immersive and,
therefore, more active (child engagement). Furthermore, a classroom (or a more playful
environment) will be simulated in which there will be different objects with which the
school children can interact, for example a blackboard, and a desk with a notebook.
- For the creation of the catalog of objects to work with AR, it will be directed above
all to work in the classroom and at home with the parents aimed at the building
students' phonological awareness and increasing their level of vocabulary.
A participatory design (co-design) for the development of VR materials from the experiences /
needs of the users will be employed in building the programs to be run on VR (Oculos) or AR
(tablets) apparatus.
A social impact assessment of the activities and results implemented by the project which
will take into account gender issues.
20 dyslexic boys and girls will be recruited in each country (60 total). Half of them will be
in the age group of 10-12y and half 13-16y.
All recruited subjects will complete the PIRLS questionnaire at admission. 5 subjects for
each age group will be randomly allocated to the intervention arm by a PC generated
randomization list and will be exposed to the VR (subjects aged 13-16) or AR (subjects aged
10-12) treatment. The treatment will last one week and imply 1 hour each day of supervised
use of the devices loaded with the specially developed software. At the end of the training
week the participants will repeat the PIRLS questionnaire and will complete the Technology
acceptance questionnaire and the Technical aspects questionnaire (both validated tools) to
assess the tolerability of the treatment. The group of subjects not exposed to treatment will
repeat the PIRLS questionnaire after one month.
The results of the tolerability questionnaires will be analysed to assess safety and
acceptance of the tools, while the possible difference in the PIRLS score pre/post treatment
will give information on efficacy.
