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Clinical Trials/NCT05808478
NCT05808478
Recruiting
Not Applicable

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country30 target enrollmentJanuary 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Communication Disabilities
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
30
Locations
1
Primary Endpoint
MacArthur-Bates Communicative Development Inventory
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2022
End Date
December 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francesca Cucinotta

Principal Investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

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

Outcomes

Primary Outcomes

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.

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.

Interactive Check list for Augmentative Communication

Time Frame: Month 6

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

Secondary Outcomes

  • Vineland Adaptive Behavior Scales II(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))
  • The World Health Organization Quality of Life(T0 (Baseline) - T1 (3 months) - T2 (6 months))

Study Sites (1)

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