Eye-tracking Technology for Severe Communication Disability

March 30, 2023 updated by: Francesca Cucinotta, IRCCS Centro Neurolesi "Bonino-Pulejo"

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MacArthur-Bates Communicative Development Inventory
Time Frame: 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.
Month 0
MacArthur-Bates Communicative Development Inventory
Time Frame: 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.
Month 3
MacArthur-Bates Communicative Development Inventory
Time Frame: 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.
Month 6
Communication Matrix
Time Frame: 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.
Month 0
Communication Matrix
Time Frame: 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.
Month 3
Communication Matrix
Time Frame: 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.
Month 6
Interactive Check list for Augmentative Communication
Time Frame: Month 0
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Month 0
Interactive Check list for Augmentative Communication
Time Frame: Month 3
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Month 3
Interactive Check list for Augmentative Communication
Time Frame: Month 6
Interactive Check list for Augmentative Communication is an observational tool for evaluating interactive behavior
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The World Health Organization Quality of Life
Time Frame: 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.
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Parenting Stress Index
Time Frame: T0 (Baseline) - T1 (3 months) - T2 (6 months)
Measures parenting stress
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Forerunners in Communication - ComFor
Time Frame: 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
T0 (Baseline) - T1 (3 months) - T2 (6 months)
Vineland Adaptive Behavior Scales II
Time Frame: 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.
T0 (Baseline) - T1 (3 months) - T2 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Centro Neurolesi "Bonino-Pulejo"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EYETRACK01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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