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Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation

Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07445035
Enrollment
30
Registered
2026-03-03
Start date
2026-06-26
Completion date
2026-12-31
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Training, Exoskeleton Device, Prolonged Mechanical Ventilation, Ventilator Dependent, Ventilator Weaning

Keywords

prolonged mechanical ventilation, ventilator weaning, lower limb muscle strengthening, exoskeleton robot, exercise training

Brief summary

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

DEVICElower-limb exoskeleton

regular therapy plus exoskeleton training

OTHERStandard medical treatment

regular therapy

Sponsors

Fu Jen Catholic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
manual muscle testing2 weeks0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.

Countries

Taiwan

Contacts

CONTACTKe-Yun Chao, PhD
C00152@mail.fjuh.fju.edu.tw+886-905-301-879
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD

Fu Jen Catholic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026