- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06947512
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Efficacy of the Personalization of Visual Parameters and Text-to-Speech to Improve Reading Speed, Accuracy and Comprehension in Students With Learning Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Seleggo is a free compensatory tool for dyslexic students. It is an online platform where school textbooks are transcribed and visualized on the screen in portable format (PDF) versions, characterized by special attention to graphical features and readability, and can be listened to via TTS technology. Special functions such as karaoke modality, conceptual maps building software, summary creation, verbal and visual definition search and the possibility to record and retrieve one's own notes and sketches are also provided. Each student with Specific learning Disorder (SLD) has a personal library and can choose the parameters for text visualization to facilitate reading, modifying the display of the text, choosing font, size and spacing, as well as TTS parameters, such as speed and pitch.
The availability of many options for text visualization and TTS, however, can be advantageous only as far as the students are able to choose and use parameters that objectively facilitate their reading and comprehension. Since the analysis of the literature suggests that subjective choices may be misleading and that general recommendations may not fit the individual's needs, we decided to build an automatized, as objective as possible procedure to help the students find the combination of parameters that is most likely to facilitate them in reading and studying. This procedure, composed by an initial, gross-grained subjective procedure and followed by a thorough, systematic analysis of reading and comprehension performance, was named "Seleggo test" to match the compensatory tool it was meant to complement.
The present study aims to assess the actual advantage of personalized parameter selection through the "Seleggo Test" procedure in supporting reading compared to the use of standard parameters. The working hypothesis is that children with reading disorders would benefit from personalized text features and TTS.
The recruitment of participants will take place in schools. It is foreseen that 30 participants are recruited for each of the three groups: typically Developing children (TD), Developmental Dyslexia (DD) and Special Educational Needs (SEN) - with reading difficulties).
Additional children will be recruited form patients with DD at Scientific Institute (IRCCS) E. Medea, if necessary to reach the expected number. Children will attend the third grade of primary school to the third grade of middle school (7 to 15 years old).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Luisa Lorusso, Ph.D
- Phone Number: 031-877592
- Email: marialuisa.lorusso@lanostrafamiglia.it
Study Locations
-
-
LC
-
Bosisio Parini, LC, Italy, 23842
- Recruiting
- IRCCS E. Medea, polo di Bosisio Parini
-
Contact:
- Maria Luisa Lorusso, Ph.D
- Phone Number: 031-877592
- Email: marialuisa.lorusso@lanostrafamiglia.it
-
Contact:
- Francesca Borasio, Ph.D
- Email: francesca.borasio@lanostrafamiglia.it
-
-
TV
-
Conegliano, TV, Italy, 31015
- Recruiting
- IRCCS E.Medea, polo di Conegliano
-
Contact:
- Federica Martinez, MD
- Email: federica.martinez@lanostrafamiglia.it
-
Treviso, TV, Italy, 31100
- Recruiting
- Associazione La Nostra Famiglia
-
Contact:
- Malida Franzoi, MD
- Email: malida.franzoi@lanostrafamiglia.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria (for TD group):
- age 7-15 years
- no history of reading difficulties
- attends school in Italy
Exclusion Criteria (for TD group):
- special educational needs or diagnosis of neurodevelopmental disorders
Inclusion Criteria (for DD group):
- age 7-15 years
- diagnosis of Developmental Dyslexia or Specific Reading Disorder
- Attends school in Italy
Exclusion Criteria (for DD group):
- diagnosis of Intellectual Disability
Inclusion Criteria (for SEN group):
- age 7-15 years
- reported by school to have significant difficulties in reading and writing
- Attends school in Italy (at least 6 months continued schooling and exposure to the Italian language)
Exclusion Criteria (for SEN group):
- diagnosis of Intellectual Disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant
All participants in the study will be assessed with the Seleggo Test procedure and then tested on reading and writing to dictation in the two conditions, with personalized and with standard visual and auditory parameters for text visualization and TTS
|
Seleggo Test is a computerized procedure to identify the personalized visual and auditory parameters facilitating reading and writing for each participant.
By applying these parameters to the visualization and to the TTS software during reading of school texts, the participants are expected to be facilitated in reading and understanding the text.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters
Time Frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between reading speed (seconds to read the text displayed by the software) with personalized and with standard visual parameters
|
Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
|
Reading facilitation (accuracy), i.e. the advantage in reading performance (accuracy) produced by personalized parameters as compared to standard parameters
Time Frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between reading accuracy (number of errors in reading the text displayed by the software) with personalized and with standard visual parameters
|
Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
|
Comprehension facilitation, i.e. the advantage in auditory comprehension performance produced by personalized TTS parameters as compared to standard parameters
Time Frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
difference between writing accuracy (number of errors in writing a pre-defined list of nonwords) for stimuli dictated with personalized and with standard auditory parameters in the TTS device
|
Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
possibility to discriminate TD students' reading speed from that of students with DD and SEN
Time Frame: about 10 months
|
difference (ANOVAs) in performance (in terms of speed, expressed in seconds per syllable) on the reading tests delivered by the software, between the three groups (TD, DD and SEN)
|
about 10 months
|
|
possibility to discriminate TD students's reading accuracy from that of students with DD and SEN
Time Frame: about 10 months
|
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the reading tests delivered by the software, between the three groups (TD, DD and SEN)
|
about 10 months
|
|
possibility to discriminate TD students' writing accuracy from that of students with DD and SEN
Time Frame: about 10 months
|
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the writing tests delivered by the software, between the three groups (TD, DD and SEN)
|
about 10 months
|
|
validity and reliability values for the reading speed measures collected by the software
Time Frame: about 10 months
|
Pearson's correlations between the speed measures collected during the test and the speed measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders).
|
about 10 months
|
|
validity and reliability values for the reading accuracy measures collected by the software
Time Frame: about 10 months
|
Pearson's correlations between the reading accuracy measures collected during the test and the accuracy measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders).
|
about 10 months
|
|
validity and reliability values for the writing accuracy measures collected by the software
Time Frame: about 10 months
|
Pearson's correlations between the writing accuracy measures collected during the test and the accuracy measures obtained on standardized writing tests (Assessment Battery for Developmental Reading and Spelling Disorders).
|
about 10 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lorusso ML, Borasio F, Panetto P, Curioni M, Brotto G, Pons G, Carsetti A, Molteni M. Validation of a Web App Enabling Children with Dyslexia to Identify Personalized Visual and Auditory Parameters Facilitating Online Text Reading. Multimodal Technologies and Interaction. 2024; 8(1):5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 996
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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