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NCT Number: NCT07445035

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

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.

Recruiting

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location status: Recruiting

Location contact

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886905301879

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lower-limb exoskeleton

Device

regular therapy plus exoskeleton training

Standard Medical Treatment

Other

regular therapy

Primary outcomes

  1. manual muscle testing

    Time frame: 2 weeks

    0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886-905-301-879

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Jul 1, 2026

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.

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