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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise Training; Ventilator Weaning; Prolonged Mechanical Ventilation; Exoskeleton Device; Ventilator Dependent
• Intervention / Treatment: Other: Standard medical treatment; Device: lower-limb exoskeleton

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: C00152@mail.fjuh.fju.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Contact: Ke-Yun Chao, PhD; Phone Number: +886905301879; Email: ck_qq@hotmail.con

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard care group; receive standard care without the intervention	Other: Standard medical treatment; regular therapy
Experimental: Powered lower-limb exoskeleton group; receive standard care with exoskeleton-assisted training	Device: lower-limb exoskeleton; regular therapy plus exoskeleton training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
manual muscle testing	0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.	2 weeks

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise training; ventilator weaning; prolonged mechanical ventilation; exoskeleton robot; lower limb muscle strengthening
• Other Study ID Numbers: FJUH114479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No