Eye-tracking Technology for Severe Communication Disability

Communication Disabilities Clinical Trial

Official title:

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808478
• Other study ID #: EYETRACK01
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Francesca Cuinotta, MD, PhD
• Phone: 09060128257
• Email: francesca.cucinotta[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communication Disabilities
• Communication Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Neurolesi Bonino Pulejo	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. Erratum In: J Speech Hear Res 1989 Sep;32(3):703. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 0
Primary	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.	Month 3
Primary	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.	Month 6
Primary	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.	Month 0
Primary	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.	Month 3
Primary	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.	Month 6
Primary	Interactive Check list for Augmentative Communication	Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior	Month 0
Primary	Interactive Check list for Augmentative Communication	Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior	Month 3
Primary	Interactive Check list for Augmentative Communication	Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior	Month 6
Secondary	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.	T0 (Baseline) - T1 (3 months) - T2 (6 months)
Secondary	Parenting Stress Index	Measures parenting stress	T0 (Baseline) - T1 (3 months) - T2 (6 months)
Secondary	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	T0 (Baseline) - T1 (3 months) - T2 (6 months)
Secondary	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.	T0 (Baseline) - T1 (3 months) - T2 (6 months)