Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- manual muscle testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
standard care group
receive standard care without the intervention
干预措施: Standard medical treatment (Other)
Powered lower-limb exoskeleton group
receive standard care with exoskeleton-assisted training
干预措施: lower-limb exoskeleton (Device)
结局指标
主要结局
manual muscle testing
时间窗: 2 weeks
0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.
次要结局
未报告次要终点
研究者
Ke-Yun, Chao
Assistant Professor
Fu Jen Catholic University