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Идёт набор NCT06237829

Testing Tactile Aids With Blind Subjects

Без фазы С лечением Vision, Low Blindness

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: Single bump acuity, Optimal spacing between bumps, Improving signal from a single bump with designer materials.
Кому может быть актуально
Состояния в реестре: Vision, Low, Blindness. Базовые параметры: от 16 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The objective of this project is to create richer tactile aids by using materials chemistry to create tactile sensations in tactile aids, as an alternative to traditional physical bumps, lines, or textures. These materials are commonly used in household products, but have not yet been used to enrich tactile aids. Successful outcomes are primarily the accuracy with which low vision or blind subjects identify objects made from tactile coatings versus traditional tactile aids. Other outcomes include time to completion of the task, or the number of distinctive categories that participants can identify.

Подробное описание

Traditional images and graphics, like mathematical plots or charts, are not accessible to low vision and blind people. Instead, for blind and low vision people, tactile aids are traditionally used to convey abstract concepts. However, tactile aids cannot convey as rich or as dense of information as traditional visual graphics, limiting independence and access to gainful employment for low vision and blind professionals.

The primary reason why tactile aids are inferior to visual graphics is that tactile aids are made from a combination of physical bumps, lines, and labels. Placing too many details on a single tactile aid quickly becomes illegible to the user because the various bumps, lines, and textures blur together, which is known as "tactile clutter".

The objective of this project is to create richer tactile aids by using materials chemistry to create tactile sensations in tactile aids, as an alternative to traditional physical bumps, lines, or textures. These materials are commonly used in household products, but have not yet been used to enrich tactile aids. Successful outcomes include having low vision or blind subjects identify objects made from our tactile materials quicker than traditional tactile aids, or to successfully identify more categories on a mathematical plot than is currently possible with existing tactile aids.

Вмешательства

  • Поведенческое Single bump acuity
    Investigators will design bumps of varying heights, spacings, diameters, and bump shapes (rounded top, flat top, angled top) which give a precise amount of mechanical stimulus to the finger. Subjects will be asked if they could notice a bump on the surface and instructed to make the judgment quickly (\<2 seconds). A psychometric curve, with a standard braille bump serving as the positive, \~100% success rate control, will be constructed
  • Поведенческое Optimal spacing between bumps
    Investigators will fabricate and characterize two bumps of varying widths (ranging from 150 μm to 3 times the bump width, based on fabrication resolution available in commercial tactile aid machines). Subjects will be asked to run their finger across the two bumps (two bumps always form a line, so investigators do not need to ask subjects to orient their fingers) quickly and asked if they felt one bump or two.
  • Поведенческое Improving signal from a single bump with designer materials
    Investigators will coat single bumps with our designer materials (with alkyl and amino functional groups) to improve the mechanical stimuli from a single bump. Subjects will then be asked to perform a similar experiment as the "single bump acuity" test and the "optimal spacing between bumps" test. ("can you notice the bump?" or "did you feel one or two bumps").

Первичные конечные точки

  • Success rate for correctly interpreting a tactile numeric plot of the GDP (Gross Domestic Product) of four countries. [Срок оценки: Immediately after human testing (middle of year 2)]
  • Usability of GDP plot tactile aid. [Срок оценки: Immediately after human testing (middle of year 2)]
  • Time to completion of a tactile board game. [Срок оценки: Immediately after human testing with this tactile aid (end of year 3)]
  • Success rate to completion for a fake money counting task. [Срок оценки: Immediately after human testing with this tactile aid (end of year 4)]
  • Success time to completion for a fake money counting task. [Срок оценки: Immediately after human testing with this tactile aid (end of year 4)]
  • Usability and general feedback [Срок оценки: Through study completion, 4 years.]

Критерии участия

Критерии включения

  • Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
  • Tactile Aid Usage: Participants must use tactile aids regularly.
  • Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.

Критерии исключения

\- Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Delaware — Newark

Идентификаторы

NCT: NCT06237829 · 372362

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗