Prolonged Mechanical VentilationNCT07445035
Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation
A study testing lower-limb exoskeleton and Standard medical treatment in people with Prolonged Mechanical Ventilation and Ventilator Weaning, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Prolonged Mechanical Ventilation, Ventilator Weaning, Ventilator Dependent
- What is being tested?
- lower-limb exoskeleton and Standard medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886905301879, ck_qq@hotmail.con
About this study
Official title: 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.
Read the 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
- Conditions
- Prolonged Mechanical Ventilation, Ventilator Weaning, Ventilator Dependent, Exoskeleton Device, Exercise Training
- Being tested
- lower-limb exoskeleton, Standard medical treatment
- Keywords
- prolonged mechanical ventilation, ventilator weaning, lower limb muscle strengthening, exoskeleton robot, exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower-limb exoskeletonDevice
regular therapy plus exoskeleton training
Standard medical treatmentOther
regular therapy
| Study group | Role | What they receive |
|---|---|---|
| standard care group | Active comparator | receive standard care without the intervention Receives: Other: Standard medical treatment |
| Powered lower-limb exoskeleton group | Experimental | receive standard care with exoskeleton-assisted training Receives: Device: lower-limb exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
manual muscle testing
0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start26 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445035
- Sponsor's protocol ID
- FJUH114479
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients
- ClinicalTrials.gov ID
- NCT07445035
- Acronym / sponsor ID
- FJUH114479
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | Active comparator | Other: Standard medical treatmentreceive standard care without the intervention |
| Powered lower-limb exoskeleton group | Experimental | Device: lower-limb exoskeletonreceive standard care with exoskeleton-assisted training |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- Inability to follow instructions.
- Intubation/tracheostomy prior to current admission.
- Diagnosis of severe left heart failure.
- Diagnosis of neuromuscular disorders.
- Unable to stand.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower-limb exoskeletonregular therapy plus exoskeleton training | Device | Powered lower-limb exoskeleton group |
| Standard medical treatmentregular therapy | Other | standard care group |
Primary outcome
manual muscle testing
Time frame: 2 weeks
0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower-limb exoskeleton and Standard medical treatment in people with Prolonged Mechanical Ventilation and Ventilator Weaning, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886-905-301-879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
manual muscle testing (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.