Исследование автоматической настройки динамического AFO
Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Katheryn Allyn, CPO, LPO
- Номер телефона: 206-390-0228
Учебное резервное копирование контактов
- Имя: Joan Sanders, PhD
- Номер телефона: 206-221-5872
- Электронная почта: jsanders@uw.edu
Места учебы
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Washington
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Seattle, Washington, Соединенные Штаты, 98105
- Рекрутинг
- University of Washington, Dept. of Bioengineering
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Контакт:
- Joan Sanders, PhD
- Номер телефона: 206-221-5872
- Электронная почта: jsanders@uw.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria (Healthy Volunteers):
-able to run continuously for 1 minute
Inclusion Criteria (All Other Volunteers)
- prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
- Use prescribed offloading AFO at least 20 hours per week
- Prescribed AFO strut length of at least 200 mm
- Able to run continuously for 1 minute
Exclusion Criteria (Healthy Volunteers):
- limited sensation in the lower limbs
- use an assistive device
Exclusion Criteria (All Other Volunteers):
- Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
- Unable to sit, stand, or negotiate a step onto lab treadmill
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Aim 2
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. |
The Dynamic AFO is able to adjust in stiffness depending on activity. |
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Экспериментальный: Aim 3
Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a "locked" mode that functions similar to their own orthotic--the order in which they are tested will be randomized. |
The Dynamic AFO is able to adjust in stiffness depending on activity. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time Running Per Day
Временное ограничение: Calculated across all days of data collection (up to 4 weeks).
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Collected while participant uses device in free-living environment. |
Calculated across all days of data collection (up to 4 weeks).
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Longest Running Bout Duration
Временное ограничение: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
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Collected while participant uses device in free-living environment. |
Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
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PROMIS-Fatigue
Временное ограничение: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
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Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating a greater level of fatigue. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
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Pain Score
Временное ограничение: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
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Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each Pain-Score question asks participants to rank on a scale from 1 to 10 (categorical options), with higher scores indicating a greater level of pain. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
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Orthotic Evaluation Questionnaire (OEQ)
Временное ограничение: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
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Similar to the Prosthesis Evaluation Questionnaire (PEQ), the OEQ will ask various questions concerning their experience wearing the variable stiffness AFO. Participants will rate their overall satisfaction, ability to ambulate, the health of their limb, the utility of the device, and their overall well-being after wearing the device. |
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
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Running Speed on Treadmill
Временное ограничение: In-lab testing will occur over the course of up to 2 hours at a time.
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Participants carrying out the in-lab protocol will be asked to run using the variable stiffness AFO and running speed will be documented at various time points. |
In-lab testing will occur over the course of up to 2 hours at a time.
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Extended Figure-of-8 Test
Временное ограничение: In-lab testing wil occur over the course of up to 2 hours at a time.
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Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test. |
In-lab testing wil occur over the course of up to 2 hours at a time.
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Joan E Sanders, PhD, University of Washington
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- STUDY00009120
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .