VAlidation of an Educational Technological Tool for Dyslexic Adolescents: an Open Controlled Study
FORDYS
Validazione di un Supporto Tecnologico Educativo Per Ragazzi Con Dislessia. Studio Aperto Randomizzato e Controllato
1 other identifier
interventional
60
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2021
CompletedFirst Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 21, 2023
March 1, 2023
9 months
August 25, 2021
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
scores at the TAM (technology assessment questionnaire)
tolerability on the validated scale scoring 20-100 (higher score better acceptance)
5 days
Secondary Outcomes (1)
change in the PIRLS (Proficiency in reading skills) questionnaire scores
5 days
Study Arms (4)
VR treatment
ACTIVE COMPARATOR5 subjects per country aged 13-16 treated with VR supported (Oculos) program, one hour a day for 5 days
AR treatment
ACTIVE COMPARATOR5 subjects per country aged 10-13 treated with AR supported (tablet) program, one hour a day for 5 days
control age 13-16
NO INTERVENTIONdyslexic subjects aged 13-16 not randomized to active treatment
Control age 10-12
NO INTERVENTIONdyslexic subjects aged 10-12 not randomized to active treatment
Interventions
one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a VR device (Oculos)
one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a AR device (tablet)
Eligibility Criteria
You may qualify if:
- junior high school students aged 10-16y
- diagnosis of dyslexia
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS Eugenio Medealead
- Universidad de Burgoscollaborator
- Asociatia Bucuresti Pentru Copii Dislexicicollaborator
- Augumented Reality Software ARSOFTcollaborator
Study Sites (1)
IRCCS Medea
Conegliano, Treviso, 31015, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 31, 2021
Study Start
April 9, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
March 21, 2023
Record last verified: 2023-03