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Eye-tracking Technology for Severe Communication Disability

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05808478
Enrollment
30
Registered
2023-04-11
Start date
2022-01-22
Completion date
2026-12-31
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication Disabilities

Keywords

Augmentative and Alternative Communication, Eye tracker, Communication Disabilities

Brief summary

The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system.

Detailed description

The term complex communication needs includes all patients who present severe disturbances in speech and language production and/or in comprehension, in relation to oral or written communication modalities. The main purpose of Augmentative and Alternative Communication (AAC) is to promote the best possible communication for people with complex communication needs, through the use of techniques, methods and tools aimed not at replacing pre-existing communication methods but at increasing skills of natural communication through the enhancement of present skills. The Eye tracker system, thanks to allows the recording and analysis of eye movements, could be used successfully to support communication in patients with severe communication disability. The goal of this study is to develop an efficacy Augmentative and Alternative Communication intervention using eye-tracking technology for patients with severe communication disability. The secondary objective was to examine the psychosocial impact of technology for AAC on parents' perspectives and quality of life.

Interventions

BEHAVIORALAAC + Eye Tracking

The AAC treatment will be supported by the use of an innovative high-tech tool, such as Eye Tracking. The duration of treatment will be 6 months, with sessions of 45 minutes twice a week.

BEHAVIORALAAC

Treatment involves the use of conventional AAC, with low-tech tools, such as PECS or sign language. The duration of treatment will be six months, twice a week, with sessions of 45 minutes.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* aged between 3 and 17 years affected by neuropsychiatric pathology presenting complex communication needs * Control of eye motility and visual fixation * ability to maintain position in front of the monitor * availability of at least one member of the family nucleus to participate in the therapeutic process * cognitive skills appropriate to the task such as being able to recognize images and being able to memorize procedures necessary to use the various basic functions

Exclusion criteria

* age not between 3 and 17 years * difficulty in controlling ocular motility and visual fixation * the unavailability of at least one member of the family nucleus to participate in the therapeutic process * impaired cognitive skills on the task such as being able to recognize pictures and being able to memorize procedures necessary to use various basic functions

Design outcomes

Primary

MeasureTime frameDescription
MacArthur-Bates Communicative Development InventoryMonth 0The MacArthur-Bates Communicative Development Inventory is a questionnaire for parents. This is used for the study and evaluation of communication and language in children with typical and atypical development.
Communication MatrixMonth 0is an online assessment tool created to help professionals and family members support people with severe communication disorders on their journey to greater self-expression. Total score on an assessment of early expressive communication skills.
Interactive Check list for Augmentative CommunicationMonth 0Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior

Secondary

MeasureTime frameDescription
Vineland Adaptive Behavior Scales IIT0 (Baseline) - T1 (3 months) - T2 (6 months)The Vineland Adaptive Behavior Scales are a standardized semi-structured interview to measure adaptive behavior, among the most sensitive to change in autism research. Standard scores have a mean of 100 and a standard deviation of 15.
Forerunners in Communication - ComForT0 (Baseline) - T1 (3 months) - T2 (6 months)Forerunners in Communication assesses the precursors of augmentative communication. It measures the ability to perceive and attribute meanings to forms of communication
The World Health Organization Quality of LifeT0 (Baseline) - T1 (3 months) - T2 (6 months)The World Health Organization Quality of Life -BREF consists of 26 questions. The World Health Organization Quality of Life -BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Parenting Stress IndexT0 (Baseline) - T1 (3 months) - T2 (6 months)Measures parenting stress

Countries

Italy

Contacts

Primary ContactFrancesca Cuinotta, MD, PhD
francesca.cucinotta@irccsme.it09060128257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026