Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lower-limb exoskeleton, Standard medical treatment.
- Who it may be relevant to
- Registry conditions: Prolonged Mechanical Ventilation, Ventilator Weaning, Ventilator Dependent, Exoskeleton Device. Basic parameters: 45 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients
Overview
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.
Detailed description
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
Interventions
- Device lower-limb exoskeleton
regular therapy plus exoskeleton training - Other Standard medical treatment
regular therapy
Primary outcome measures
- manual muscle testing [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Identifiers
NCT: NCT07445035 · FJUH114479