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Communication DisabilitiesNCT05808478

Eye-tracking Technology for Severe Communication Disability

A study testing AAC + Eye Tracking and AAC in people with Communication Disabilities, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Communication Disabilities
What is being tested?
AAC + Eye Tracking and AAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
22 Jan 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Francesca Cuinotta, MD, PhD contact

09060128257

francesca.cucinotta@irccsme.it

Italy1 site, 1 recruiting

  • IRCCS Neurolesi Bonino Pulejo

    Messina, 98100

    Francesca Cucinotta, PhD, 09060128256, francesca.cucinotta@irccsme.it

    Recruiting

Other trials in Italy

About this study

Official title: Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

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

Read the 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.

Being tested
AAC + Eye Tracking, AAC
Keywords
Augmentative and Alternative Communication, Eye tracker, Communication Disabilities
Medical subject headings
Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AAC + Eye TrackingBehavioural

    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.

  • AACBehavioural

    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.

Study groups in NCT05808478
Study groupRoleWhat they receive
Experimental Group (EG)ExperimentalThe experimental group will undergo treatment with innovative high-tech tools, such as Eye Tracking, for communication purposes. The duration of the treatment will be six months, twice a week, with sessions of 45 minutes.
Receives: Behavioral: AAC + Eye Tracking
Control Group (CG)Active comparatorThe control group will undergo conventional AAC treatment, with low-tech tools, such as PECS or sign language. The duration of the treatment will be six months, twice a week, with sessions of 45 minutes.
Receives: Behavioral: AAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MacArthur-Bates Communicative Development Inventory

    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.

    Measured: Month 0

  2. MacArthur-Bates Communicative Development Inventory

    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.

    Measured: Month 3

  3. MacArthur-Bates Communicative Development Inventory

    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.

    Measured: Month 6

  4. Communication Matrix

    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.

    Measured: Month 0

  5. Communication Matrix

    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.

    Measured: Month 3

  6. Communication Matrix

    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.

    Measured: Month 6

  7. Interactive Check list for Augmentative Communication

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

    Measured: Month 0

  8. Interactive Check list for Augmentative Communication

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

    Measured: Month 3

  9. Interactive Check list for Augmentative Communication

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

    Measured: Month 6

Secondary outcomes (4)

  1. The World Health Organization Quality of Life

    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.

    Measured: T0 (Baseline) - T1 (3 months) - T2 (6 months)

  2. Parenting Stress Index

    Measures parenting stress

    Measured: T0 (Baseline) - T1 (3 months) - T2 (6 months)

  3. Forerunners in Communication - ComFor

    Forerunners in Communication assesses the precursors of augmentative communication. It measures the ability to perceive and attribute meanings to forms of communication

    Measured: T0 (Baseline) - T1 (3 months) - T2 (6 months)

  4. Vineland Adaptive Behavior Scales II

    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.

    Measured: T0 (Baseline) - T1 (3 months) - T2 (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start22 Jan 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808478
Sponsor's protocol ID
EYETRACK01
Status last verified
Mar 2023
First submitted
17 Mar 2023
Last updated
11 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mirenda P, Eicher D, Beukelman DR. Synthetic and natural speech preferences of male and female listeners in four age groups. J Speech Hear Res. 1989 Mar;32(1):175-83. doi: 10.1044/jshr.3201.175.

    PubMed 2523007

  • Corallo F, Bonanno L, Lo Buono V, De Salvo S, Rifici C, Pollicino P, Allone C, Palmeri R, Todaro A, Alagna A, Bramanti A, Bramanti P, Marino S. Augmentative and Alternative Communication Effects on Quality of Life in Patients with Locked-in Syndrome and Their Caregivers. J Stroke Cerebrovasc Dis. 2017 Sep;26(9):1929-1933. doi: 10.1016/j.jstrokecerebrovasdis.2017.06.026. Epub 2017 Jul 18.

    PubMed 28733123

  • Uliano D, Falciglia G, Del Viscio C, Picelli A, Gandolfi M, Passarella A. Augmentative and alternative communication in adolescents with severe intellectual disability: a clinical experience. Eur J Phys Rehabil Med. 2010 Jun;46(2):147-52. Epub 2010 Apr 13.

    PubMed 20485219

Questions about this trial

What is this clinical trial studying?

A study testing AAC + Eye Tracking and AAC in people with Communication Disabilities, run by IRCCS Centro Neurolesi Bonino Pulejo 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Apr 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesca Cuinotta, MD, PhD (09060128257, francesca.cucinotta@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MacArthur-Bates Communicative Development Inventory (time frame: Month 0). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05808478, which also lists 3 linked publications.

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 11 Apr 2023.

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