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RecruitingNCT05808478Updated Apr 11, 2023

Eye-tracking Technology for Severe Communication Disability

An interventional study of AAC + Eye Tracking and AAC in Communication Disabilities, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Recruiting at 1 site in Italy. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Communication Disabilities

Keywords

  • Augmentative and Alternative Communication, Eye tracker, Communication Disabilities
03

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental Group (EG)

    The 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.

    Behavioral: AAC + Eye Tracking

  • Active comparator
    Control Group (CG)

    The 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.

    Behavioral: AAC

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.

05

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Month 6

  7. Interactive Check list for Augmentative Communication

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

    Time frame: Month 0

  8. Interactive Check list for Augmentative Communication

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

    Time frame: Month 3

  9. Interactive Check list for Augmentative Communication

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

    Time frame: Month 6

Secondary outcomes

  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.

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

  2. Parenting Stress Index

    Measures parenting stress

    Time frame: 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

    Time frame: 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.

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

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. Erratum In: J Speech Hear Res 1989 Sep;32(3):703. 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 ↗
08

Registry details

Key details

Study ID
NCT05808478
Lead sponsor
IRCCS Centro Neurolesi Bonino Pulejo
Responsible party
Francesca Cucinotta (Principal Investigator, IRCCS Centro Neurolesi Bonino Pulejo) — Principal investigator
First posted
Apr 11, 2023
Start date
Jan 22, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 11, 2023

Study contacts

Francesca Cuinotta, MD, PhD
Contact
francesca.cucinotta@irccsme.it
09060128257

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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