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Идёт набор NCT05808478

Eye-tracking Technology for Severe Communication Disability

Без фазы С лечением Communication Disabilities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AAC + Eye Tracking, AAC.
Кому может быть актуально
Состояния в реестре: Communication Disabilities. Базовые параметры: 3 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

  • MacArthur-Bates Communicative Development Inventory [Срок оценки: Month 0]
  • MacArthur-Bates Communicative Development Inventory [Срок оценки: Month 3]
  • MacArthur-Bates Communicative Development Inventory [Срок оценки: Month 6]
  • Communication Matrix [Срок оценки: Month 0]
  • Communication Matrix [Срок оценки: Month 3]
  • Communication Matrix [Срок оценки: Month 6]
  • Interactive Check list for Augmentative Communication [Срок оценки: Month 0]
  • Interactive Check list for Augmentative Communication [Срок оценки: Month 3]
  • Interactive Check list for Augmentative Communication [Срок оценки: Month 6]
Вторичные конечные точки (4)
  • The World Health Organization Quality of Life [Срок оценки: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Parenting Stress Index [Срок оценки: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Forerunners in Communication - ComFor [Срок оценки: T0 (Baseline) - T1 (3 months) - T2 (6 months)]
  • Vineland Adaptive Behavior Scales II [Срок оценки: T0 (Baseline) - T1 (3 months) - T2 (6 months)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Италия · 1 центр
  • IRCCS Neurolesi Bonino Pulejo — Messina

Публикации

  • 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. PMID 2523007
  • 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. PMID 28733123
  • 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. PMID 20485219

Идентификаторы

NCT: NCT05808478 · EYETRACK01

Первоисточники (государственные реестры)

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