Eye-tracking Technology for Severe Communication Disability

NCT05808478 | Recruiting

• 1 other identifier: EYETRACK01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Communication Disabilities

Keywords

Augmentative and Alternative Communication, Eye tracker, Communication Disabilities

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• Interactive Check list for Augmentative Communication

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

  Month 0

• Interactive Check list for Augmentative Communication

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

  Month 3

• Interactive Check list for Augmentative Communication

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

  Month 6

Secondary Outcomes (4)

• The World Health Organization Quality of Life

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

• Parenting Stress Index

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

• Forerunners in Communication - ComFor

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

• Vineland Adaptive Behavior Scales II

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

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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

Control Group (CG)

ACTIVE COMPARATOR

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

AAC + Eye Tracking BEHAVIORAL

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.

Experimental Group (EG)

AAC BEHAVIORAL

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.

Control Group (CG)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi Bonino Pulejo

Messina, 98100, Italy

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Francesca Cuinotta, MD, PhD

CONTACT

09060128257; francesca.cucinotta@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 11, 2023
• Study Start: January 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

IT (1)