Меню
Идёт набор NCT05729061

Analysis of Human Movement With Assistive Devices

Без фазы С лечением Limb Loss Limb Weakness Limb Paralysis Movement Disorders

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: Assist-Knee, Prosthetic Knee, Prosthetic Ankle, Prosthetic Foot.
Кому может быть актуально
Состояния в реестре: Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders. Базовые параметры: 18 лет — 90 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization. Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.

Вмешательства

  • Устройство Assist-Knee
    Investigational prosthetic knee-ankle device
  • Устройство Prosthetic Knee
    Commercially available prosthetic knee devices
  • Устройство Prosthetic Ankle
    Commercially available prosthetic ankle devices
  • Устройство Prosthetic Foot
    Commercially available prosthetic foot devices
  • Устройство Ankle-Foot Orthosis
    Commercially available ankle-foot orthosis devices

Первичные конечные точки

  • Walking Speed with no intervention [Срок оценки: Collection at baseline]
  • Walking Speed with intervention [Срок оценки: Collection immediately after acclimation with intervention]
Вторичные конечные точки (4)
  • Time to Complete Sit-to-Stand with no intervention [Срок оценки: Collection at baseline]
  • Time to Complete Sit-to-Stand with intervention [Срок оценки: Collection immediately after acclimation with intervention]
  • Timed Up and Go (TUG) Test [Срок оценки: Collection at baseline]
  • Timed Up and Go (TUG) Test with intervention [Срок оценки: Collected immediately after acclimation with intervention]

Критерии участия

Inclusion Criteria for Nondisabled Participants:

  • Age 18 - 90 years
  • Has bilateral normal range of motion
  • Able to perform a variety of movement activities
  • Able to communicate and write individual perceptions in English
  • Able to provide written informed consent
  • Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill

Exclusion Criteria for Nondisabled Participants:

  • Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
  • Pregnancy
  • Not able to read and understand English

Inclusion Criteria for Participants with a Disability:

  • Age 18 - 90 years
  • Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
  • Medically stable
  • Has stable balance
  • Able to perform a variety of movement activities
  • Able to communicate and write individual perceptions in English
  • Able to provide written informed consent
  • Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
  • Able to safely complete the movements being tested and/or safely use the assistive devices being tested

Exclusion Criteria for Participants with a Disability:

  • Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
  • Pregnancy
  • Not able to read and understand English

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
Другое

Центры проведения

США · 1 центр
  • Orthocare Innovations, LLC — Edmonds

Идентификаторы

NCT: NCT05729061 · AD-001 · R44HD097826

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗