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Идёт набор NCT05600140

Viewing Strategy Training in Children With (Cerebral) Visual Impairment

Без фазы С лечением Vision Disorders Vision, Low

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: Viewing strategy training.
Кому может быть актуально
Состояния в реестре: Vision Disorders, Vision, Low. Базовые параметры: 5 лет — 12 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Viewing Strategy Training in Children With (Cerebral) Visual Impairment: From Spontaneous Eye Movements to a Structured Viewing Strategy

Обзор

Viewing strategies are strategies used to process visual Information. Many children with visual impairment seem to lack systematic viewing strategies. However, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. In addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach. The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI, and (2) to evaluate whether training viewing strategies results in more efficiënt visual Information processing.

Вмешательства

  • Поведенческое Viewing strategy training
    Children receive a visual training of viewing strategies (six weeks, 2 times a week, 30 minutes). During the training, children are instructed to use specific viewing strategies (looking in a structured direction which fits the task at hand, zooming in and out / change of visual selective attentional field, visual discrimination). The verbal instructions and exercises are protocol-based. A textbook is used to describe the reactions of the children during training.

Первичные конечные точки

  • Changes in reading accuracy after viewing strategy training [Срок оценки: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
  • Changes in reading speed after viewing strategy training [Срок оценки: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
  • Changes in visual search accuracy after training [Срок оценки: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
  • Changes in visual search speed after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in saccade amplitudes during reading and visual search after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in fixation duration during reading and search after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in average distance between fixation points during conjunction search (EB-VSA) after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Вторичные конечные точки (4)
  • Changes in WISC-V visual processing speed index (VSI) after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in local visual selective attention after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in global visual selective attention after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
  • Changes in visual identification speed after training [Срок оценки: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]

Критерии участия

Inclusion criteria typically developing children with normal vision:

  • Age 5-12 years
  • linear distant visual acuity of 0.1 logMAR or better
  • Verbal IQ above 70
  • Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with ocular visual impairment:

  • Age 5-12 years
  • Children with linear distance visual acuity better <=1.3logMAR and >0.1 logMAR
  • Intact central visual field (at least > 30 degrees)
  • Children with a verbal IQ above 70
  • Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with cerebral visual impairment:

  • Age 5-12 years
  • Linear distance visual acuity <=0.3 logMAR
  • Having the diagnosis CVI (verified by ophthalmologists)
  • Children with a verbal IQ above 70
  • Absence of psychiatric problems like ASS or AD(H)D

Additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. Training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). The age range for study 2 is 5-9 years.

Критерии исключения

  • Children with VI: linear near visual acuity >1.0 logMAR
  • Children with visual field defect < 30 degrees
  • Children with a verbal IQ below 70
  • Children who attended a form of vision training in the past two years
  • Children with psychiatric problems like ASS or AD(H)D
  • Auditory impairment or language impairments
  • Major life events during training

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • Royal Dutch Visio — Nijmegen

Идентификаторы

NCT: NCT05600140 · NL81584.091.22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗