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NCT Number: NCT05808478

Eye-tracking Technology for Severe Communication Disability

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

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Key information

Conditions

Communication Disabilities Communication Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Neurolesi Bonino Pulejo

Messina, 98100, Italy

Location status: Recruiting

Location contact

Francesca Cucinotta, PhD

CONTACT

[email protected]

09060128256

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AAC + Eye Tracking

Behavioral

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.

AAC

Behavioral

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.

Primary outcomes

  1. MacArthur-Bates Communicative Development Inventory

    Time frame: Month 0

    The 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.

  2. MacArthur-Bates Communicative Development Inventory

    Time frame: Month 3

    The 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.

  3. MacArthur-Bates Communicative Development Inventory

    Time frame: Month 6

    The 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.

  4. Communication Matrix

    Time frame: Month 0

    is 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.

  5. Communication Matrix

    Time frame: Month 3

    is 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.

  6. Communication Matrix

    Time frame: Month 6

    is 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.

  7. Interactive Check list for Augmentative Communication

    Time frame: Month 0

    Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior

  8. Interactive Check list for Augmentative Communication

    Time frame: Month 3

    Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior

  9. Interactive Check list for Augmentative Communication

    Time frame: Month 6

    Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior

Secondary outcomes

  1. The World Health Organization Quality of Life

    Time frame: T0 (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.

  2. Parenting Stress Index

    Time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)

    Measures parenting stress

  3. Forerunners in Communication - ComFor

    Time frame: T0 (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

  4. Vineland Adaptive Behavior Scales II

    Time frame: T0 (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Cuinotta, MD, PhD

CONTACT

[email protected]

09060128257

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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