Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation
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: lower-limb exoskeleton, Standard medical treatment.
- Кому может быть актуально
- Состояния в реестре: Prolonged Mechanical Ventilation, Ventilator Weaning, Ventilator Dependent, Exoskeleton Device. Базовые параметры: 45 лет — 65 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
- Тайвань
- 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
Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients
Обзор
This study aims to evaluate the effects of powered lower-limb exoskeleton-assisted training on lower limb strength, respiratory parameters, 28-day ventilator-free days, and length of hospital stay in patients with prolonged mechanical ventilation admitted to a Respiratory Care Center. The goal is to provide clinical evidence for integrating rehabilitation and respiratory care in this patient population.
Подробное описание
Background:
Patients with prolonged mechanical ventilation often experience lower limb muscle weakness, respiratory muscle dysfunction, and impaired functional status due to prolonged bed rest, leading to lower weaning success rates and extended hospital stays. In recent years, exoskeleton robots have emerged as assistive training tools and have demonstrated potential in improving lower limb function and cardiopulmonary endurance in neurological and orthopedic populations. However, evidence supporting their use in prolonged mechanical ventilation patients remains limited.
Study Design: This study will be conducted in the Respiratory Care Center of Fu Jen Catholic University Hospital using purposive sampling.
Methods:
A total of 30 prolonged mechanical ventilation patients will be recruited and matched in a 1:1 ratio based on gender, age, and intensive care unit length of stay. The intervention group will receive exoskeleton-assisted training, while the control group will receive standard care without the intervention. Recruitment and informed consent will be conducted by research staff unaffiliated with the Respiratory Care Center.
Effect:
The study is expected to identify differences between the exoskeleton intervention and control groups in terms of lower limb muscle strength, respiratory physiological parameters, 28-day ventilator-free days, and hospital length of stay. The results will provide scientific evidence and practical guidance for the clinical integration of exercise rehabilitation and respiratory care for prolonged mechanical ventilation patients.
Key words:
Prolonged Mechanical Ventilation, Exoskeleton Robot, Exercise Training, Lower Limb Muscle Strengthening, Ventilator Weaning
Вмешательства
- Устройство lower-limb exoskeleton
regular therapy plus exoskeleton training - Другое Standard medical treatment
regular therapy
Первичные конечные точки
- manual muscle testing [Срок оценки: 2 weeks]
Критерии участия
Критерии включения
- Able to maintain a seated position for at least 1 minute.
- The participant or their legal representative is able to sign the informed consent form.
Критерии исключения
- Inability to follow instructions.
- Intubation/tracheostomy prior to current admission.
- Diagnosis of severe left heart failure.
- Diagnosis of neuromuscular disorders.
- Unable to stand.
- Complete paralysis of the lower extremities.
- Presence of unhealed ulcers in the lower extremities.
- Deep vein thrombosis of the lower extremities.
- Lower-limb amputation.
- Severe hypertension
- Severe cardiac conditions
- Severe bilateral joint disorders
- Severe pain while standing
- Severe osteoporosis
- Lower-limb fracture
- Ongoing epileptic seizure
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Тайвань · 1 центр
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Идентификаторы
NCT: NCT07445035 · FJUH114479