DyslexiaFORDYSNCT05028647
VAlidation of an Educational Technological Tool for Dyslexic Adolescents: an Open Controlled Study
A study testing Virtual reality training and Augmented reality training in people with Dyslexia, run by IRCCS Eugenio Medea at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Virtual reality training and Augmented reality training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- junior high school students aged 10-16y
- diagnosis of dyslexia
Who cannot join
- cognitive impairment (QI<85),
- diagnosis of conditions not compatible with the exposure to VR or AR environments:
- epilepsy,
- photosensibility,
- vestibular problems,
- perceptual problems,
- psychiatric conditions)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validazione di un Supporto Tecnologico Educativo Per Ragazzi Con Dislessia. Studio Aperto Randomizzato e Controllato
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
Read the detailed 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.
- Conditions
- Dyslexia
- Being tested
- Virtual reality training, Augmented reality training
- Keywords
- learning disability
- Medical subject headings
- Dyslexia, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality trainingDevice
one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a VR device (Oculos)
Augmented reality trainingDevice
one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a AR device (tablet)
| Study group | Role | What they receive |
|---|---|---|
| VR treatment | Active comparator | 5 subjects per country aged 13-16 treated with VR supported (Oculos) program, one hour a day for 5 days Receives: Device: Virtual reality training |
| AR treatment | Active comparator | 5 subjects per country aged 10-13 treated with AR supported (tablet) program, one hour a day for 5 days Receives: Device: Augmented reality training |
| control age 13-16 | No intervention | dyslexic subjects aged 13-16 not randomized to active treatment |
| Control age 10-12 | No intervention | dyslexic subjects aged 10-12 not randomized to active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores at the TAM (technology assessment questionnaire)
tolerability on the validated scale scoring 20-100 (higher score better acceptance)
Measured: 5 days
Secondary outcomes (1)
change in the PIRLS (Proficiency in reading skills) questionnaire scores
efficacy. scoring is qualitative on the various items reflecting the reading proficiency, typical scores between 300-700 (higher score better performance)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start9 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open randomized control trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Burgos, Asociatia Bucuresti Pentru Copii Dislexici, Augumented Reality Software ARSOFT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028647
- Sponsor's protocol ID
- 823
- Acronym
- FORDYS
- Status last verified
- Mar 2023
- First submitted
- 25 Aug 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validazione di un Supporto Tecnologico Educativo Per Ragazzi Con Dislessia. Studio Aperto Randomizzato e Controllato
- ClinicalTrials.gov ID
- NCT05028647
- Acronym / sponsor ID
- FORDYS / 823
- Conditions
- Dyslexia
- Keywords
- learning disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Universidad de Burgos, Asociatia Bucuresti Pentru Copii Dislexici, Augumented Reality Software ARSOFT
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- open randomized control trial
| Arm | Type | Receives |
|---|---|---|
| VR treatment | Active comparator | Device: Virtual reality training5 subjects per country aged 13-16 treated with VR supported (Oculos) program, one hour a day for 5 days |
| AR treatment | Active comparator | Device: Augmented reality training5 subjects per country aged 10-13 treated with AR supported (tablet) program, one hour a day for 5 days |
| control age 13-16 | No intervention | –dyslexic subjects aged 13-16 not randomized to active treatment |
| Control age 10-12 | No intervention | –dyslexic subjects aged 10-12 not randomized to active treatment |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- junior high school students aged 10-16y
- diagnosis of dyslexia
Key exclusion criteria (7 listed)
- cognitive impairment (QI<85),
- diagnosis of conditions not compatible with the exposure to VR or AR environments:
- epilepsy,
- photosensibility,
- vestibular problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality trainingone hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a VR device (Oculos) | Device | VR treatment |
| Augmented reality trainingone hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a AR device (tablet) | Device | AR treatment |
Primary outcome
scores at the TAM (technology assessment questionnaire)
Time frame: 5 days
tolerability on the validated scale scoring 20-100 (higher score better acceptance)
1 secondary outcome
change in the PIRLS (Proficiency in reading skills) questionnaire scores
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- web site of the general projectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Dyslexia
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Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
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Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training and Augmented reality training in people with Dyslexia, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores at the TAM (technology assessment questionnaire) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.