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Eye-tracking Technology for Severe Communication Disability

Primary Purpose

Communication Disabilities

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AAC + Eye Tracking
AAC
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Communication Disabilities focused on measuring Augmentative and Alternative Communication, Eye tracker, Communication Disabilities

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Neurolesi Bonino PulejoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group (EG)

Control Group (CG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Parenting Stress Index
Measures parenting stress
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
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.

Full Information

First Posted
March 17, 2023
Last Updated
March 30, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05808478
Brief Title
Eye-tracking Technology for Severe Communication Disability
Official Title
Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication Disabilities
Keywords
Augmentative and Alternative Communication, Eye tracker, Communication Disabilities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group (EG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AAC + Eye Tracking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AAC
Intervention Description
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 Measure Information:
Title
MacArthur-Bates Communicative Development Inventory
Description
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.
Time Frame
Month 0
Title
MacArthur-Bates Communicative Development Inventory
Description
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.
Time Frame
Month 3
Title
MacArthur-Bates Communicative Development Inventory
Description
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.
Time Frame
Month 6
Title
Communication Matrix
Description
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.
Time Frame
Month 0
Title
Communication Matrix
Description
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.
Time Frame
Month 3
Title
Communication Matrix
Description
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.
Time Frame
Month 6
Title
Interactive Check list for Augmentative Communication
Description
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Time Frame
Month 0
Title
Interactive Check list for Augmentative Communication
Description
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Time Frame
Month 3
Title
Interactive Check list for Augmentative Communication
Description
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
The World Health Organization Quality of Life
Description
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.
Time Frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Title
Parenting Stress Index
Description
Measures parenting stress
Time Frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Title
Forerunners in Communication - ComFor
Description
Forerunners in Communication assesses the precursors of augmentative communication. It measures the ability to perceive and attribute meanings to forms of communication
Time Frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Title
Vineland Adaptive Behavior Scales II
Description
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.
Time Frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Cuinotta, MD, PhD
Phone
09060128257
Email
francesca.cucinotta@irccsme.it
Facility Information:
Facility Name
IRCCS Neurolesi Bonino Pulejo
City
Messina
ZIP/Postal Code
98100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Cucinotta, PhD
Phone
09060128256
Email
francesca.cucinotta@irccsme.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
2523007
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.
Results Reference
background
PubMed Identifier
28733123
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.
Results Reference
background
PubMed Identifier
20485219
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.
Results Reference
background

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Eye-tracking Technology for Severe Communication Disability

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