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临床试验/NCT05808478
NCT05808478招募中不适用

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

IRCCS Centro Neurolesi Bonino Pulejo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
MacArthur-Bates Communicative Development Inventory

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Experimental Group (EG)

Experimental

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.

干预措施: AAC + Eye Tracking (Behavioral)

Control Group (CG)

Active Comparator

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.

干预措施: AAC (Behavioral)

结局指标

主要结局

MacArthur-Bates Communicative Development Inventory

时间窗: 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

时间窗: 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

时间窗: Month 6

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

MacArthur-Bates Communicative Development Inventory

时间窗: 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.

MacArthur-Bates Communicative Development Inventory

时间窗: 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.

Communication Matrix

时间窗: 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.

Communication Matrix

时间窗: 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.

Interactive Check list for Augmentative Communication

时间窗: Month 0

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

Interactive Check list for Augmentative Communication

时间窗: Month 3

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Cucinotta

Principal Investigator

IRCCS Centro Neurolesi Bonino Pulejo

研究点 (1)

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