Eye-tracking Technology for Severe Communication Disability
ConditionCommunication Disabilities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorIRCCS Centro Neurolesi Bonino Pulejo
About this trial
The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AAC + Eye Tracking
BehavioralThe 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.
AAC
BehavioralTreatment 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (EG)Experimental treatment 1 intervention
Group B: Control Group (CG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Month 02
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.
Time frame
Month 33
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.
Time frame
Month 64
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.
Time frame
Month 0Secondary outcomes
1
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.
Time frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)2
Parenting Stress Index
Measures parenting stress
Time frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)3
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
Time frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)4
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.
Time frame
T0 (Baseline) - T1 (3 months) - T2 (6 months)Sponsors and contacts
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Source ClinicalTrials.gov