Eye-tracking Technology for Severe Communication Disability

Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
Overall Status
Recruiting
CT.gov ID
NCT05808478
Collaborator
(none)
30
1
2
59.3
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: AAC + Eye Tracking
  • Behavioral: AAC
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology
Actual Study Start Date :
Jan 22, 2022
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. MacArthur-Bates Communicative Development Inventory [Month 0]

    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.

  2. MacArthur-Bates Communicative Development Inventory [Month 3]

    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.

  3. MacArthur-Bates Communicative Development Inventory [Month 6]

    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.

  4. Communication Matrix [Month 0]

    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.

  5. Communication Matrix [Month 3]

    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.

  6. Communication Matrix [Month 6]

    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.

  7. Interactive Check list for Augmentative Communication [Month 0]

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

  8. Interactive Check list for Augmentative Communication [Month 3]

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

  9. Interactive Check list for Augmentative Communication [Month 6]

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

Secondary Outcome Measures

  1. The World Health Organization Quality of Life [T0 (Baseline) - T1 (3 months) - T2 (6 months)]

    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.

  2. Parenting Stress Index [T0 (Baseline) - T1 (3 months) - T2 (6 months)]

    Measures parenting stress

  3. Forerunners in Communication - ComFor [T0 (Baseline) - T1 (3 months) - T2 (6 months)]

    Forerunners in Communication assesses the precursors of augmentative communication. It measures the ability to perceive and attribute meanings to forms of communication

  4. Vineland Adaptive Behavior Scales II [T0 (Baseline) - T1 (3 months) - T2 (6 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 17 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Neurolesi Bonino Pulejo Messina Italy 98100

Sponsors and Collaborators

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Francesca Cucinotta, Principal Investigator, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier:
NCT05808478
Other Study ID Numbers:
  • EYETRACK01
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francesca Cucinotta, Principal Investigator, IRCCS Centro Neurolesi "Bonino-Pulejo"
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2023