Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
Location status: Recruiting
NCT Number: NCT07445035
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.
Interested in participating?
Request Info45 year–65 year
All sexes
Interventional
Not applicable
New Taipei City, 24352, Taiwan
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
regular therapy plus exoskeleton training
regular therapy
Time frame: 2 weeks
0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.
Contact information is provided by the study sponsor or research team.
Fu Jen Catholic University
Other
Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06642714
Prolonged Mechanical Ventilation, Tracheostomy
Beijing, China
View Trial DetailsNCT07372794
Critical Illness, Disease Attributes
Beijing, Beijing Municipality, China
View Trial DetailsNCT06125210
Prolonged Mechanical Ventilation
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07177183
Critical Illness, Disease Attributes
Brno, Czechia
View Trial Details