Clinical trial NCT05808478: Eye-tracking Technology for Severe Communication Disability
Official title: Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Communication Disabilities
Keywords: Augmentative and Alternative Communication, Eye tracker, Communication Disabilities
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: MacArthur-Bates Communicative Development Inventory
timeFrame: Month 0
measure: MacArthur-Bates Communicative Development Inventory
timeFrame: Month 3
measure: MacArthur-Bates Communicative Development Inventory
timeFrame: Month 6
measure: Communication Matrix
timeFrame: Month 0
measure: Communication Matrix
timeFrame: Month 3
measure: Communication Matrix
timeFrame: Month 6
measure: Interactive Check list for Augmentative Communication
timeFrame: Month 0
measure: Interactive Check list for Augmentative Communication
timeFrame: Month 3
measure: Interactive Check list for Augmentative Communication
timeFrame: Month 6
Secondary outcomes:
measure: The World Health Organization Quality of Life
timeFrame: T0 (Baseline) - T1 (3 months) - T2 (6 months)
measure: Parenting Stress Index
timeFrame: T0 (Baseline) - T1 (3 months) - T2 (6 months)
measure: Forerunners in Communication - ComFor
timeFrame: T0 (Baseline) - T1 (3 months) - T2 (6 months)
measure: Vineland Adaptive Behavior Scales II
timeFrame: T0 (Baseline) - T1 (3 months) - T2 (6 months)
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Neurolesi Bonino Pulejo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.