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Recruiting NCT05808478

Eye-tracking Technology for Severe Communication Disability

No phase Interventional Communication Disabilities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AAC + Eye Tracking, AAC.
Who it may be relevant to
Registry conditions: Communication Disabilities. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

Overview

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

  • Behavioral AAC + 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.
  • Behavioral AAC
    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 outcome measures

  • MacArthur-Bates Communicative Development Inventory [Time frame: Month 0]
  • MacArthur-Bates Communicative Development Inventory [Time frame: Month 3]
  • MacArthur-Bates Communicative Development Inventory [Time frame: Month 6]
  • Communication Matrix [Time frame: Month 0]
  • Communication Matrix [Time frame: Month 3]
  • Communication Matrix [Time frame: Month 6]
  • Interactive Check list for Augmentative Communication [Time frame: Month 0]
  • Interactive Check list for Augmentative Communication [Time frame: Month 3]
  • Interactive Check list for Augmentative Communication [Time frame: Month 6]
Secondary outcome measures (4)
  • The World Health Organization Quality of Life [Time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Parenting Stress Index [Time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Forerunners in Communication - ComFor [Time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Vineland Adaptive Behavior Scales II [Time frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • IRCCS Neurolesi Bonino Pulejo — Messina

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. PMID 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. PMID 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. PMID 20485219

Identifiers

NCT: NCT05808478 · EYETRACK01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗