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

NCT07445035 | Recruiting

• 1 other identifier: FJUH114479
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• manual muscle testing

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

  2 weeks

Study Arms (2)

standard care group

ACTIVE COMPARATOR

receive standard care without the intervention

Other: Standard medical treatment

Powered lower-limb exoskeleton group

EXPERIMENTAL

receive standard care with exoskeleton-assisted training

Device: lower-limb exoskeleton

Interventions

lower-limb exoskeleton DEVICE

regular therapy plus exoskeleton training

Powered lower-limb exoskeleton group

Standard medical treatment OTHER

regular therapy

standard care group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

Study Officials

• Ke-Yun Chao, PhD

  Fu Jen Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886-905-301-879; C00152@mail.fjuh.fju.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)