Muscle WeaknessLIANA-INCT05716451
Pilot Study on Device-assisted Mobilisation of Critically Ill Patients
A study testing Device-assisted mobilisation with the sit/stand stabilizer Liana in people with Muscle Weakness and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This Pilot study will hypothesize that patients with organ insufficiency and breathing assistance in our post-anaesthesia care unit (PACU) and ICU will be mobilized more often to an ICU mobility scale (IMS) ≥ 4 (i.e. standing) using the Liana® mobilizer. Therefore a randomized controlled pilot study will be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness
- What is being tested?
- Device-assisted mobilisation with the sit/stand stabilizer Liana
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2023to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intensive care patient with ventilatory support and an expected intensive care stay of at least another 48 h
- Age ≥ 18 years
- Current length of intensive care stay < 48 h
Who cannot join
- Moribund and critically ill
- Suspected 6-month mortality > 75%.
- Increased intracranial pressure
- Critically ill after cardiopulmonary resuscitation
- Critically ill with primary neuromuscular disease or motor neuron disease
- One or more amputated extremities
Show all 13Show fewer
- Patients, within 2h after surgery
- Unstable fractures
- Severe traumatic brain injury (e.g., brain and skull injuries)
- Circulatory instability with norepinephrine > 0.3 µg/kg/min
- Patients for whom there is an indication for deep sedation (RASS -5)
- Language barrier
- Fitting of legs into leg trays is not possible due to e.g. patient weight
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Univiversitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
This Pilot study will hypothesize that patients with organ insufficiency and breathing assistance in our post-anaesthesia care unit (PACU) and ICU will be mobilized more often to an ICU mobility scale (IMS) ≥ 4 (i.e. standing) using the Liana® mobilizer. Therefore a randomized controlled pilot study will be conducted. The aim is to achieve an important physical function mile stone more often using this device.
Secondary hypotheses are:
- The intervention will relieve the burden of the health care staff in the unit
- The intervention will positively influence the functional outcome of critically ill patients
- The intervention is perceived as positive by the patients
Read the detailed description
Patients who have been treated in the ICU for a prolonged period of time often have a high degree of immobility. In this context, a state of generalized weakness associated with muscle atrophy (ICUAW) develops in approximately 40% of ICU patients. The severity of generalized weakness may be individual in each patient. It is certain that especially elderly patients and patients with prolonged immobilization have an increased incidence of ICUAW. Symptoms can be highly variable depending on the severity of the course. Some patients report weakness of the extremities to paresis and weakness of the respiratory muscles. Weakness of the respiratory musculature can lead to a prolonged weaning process of mechanical ventilation, prolonging the stay in the ICU. Functional impairments due to ICUAW may also persist many years after the ICU stay. If ICUAW is diagnosed promptly, outcome can be improved by targeted early mobilization. Early mobilization is defined as mobilization in the first 72 h from ICU admission. However, there are numerous barriers to the implementation of early mobilization in critically ill patients, so this remains a major challenge.
Various studies have shown that patients can benefit from a high level of mobilization. For example, Scheffenbichler et al. showed that a high dose of mobilization was associated with increased independence of patients after discharge. The level of mobilization showed positive effects not only in this study, but also in Paton and colleagues. They were able to show that achieving a higher level of mobility (according to the Intensive Care Mobility Scale) was associated with improved outcome at six months. They found that achieving a higher level of mobilization positively affected the health status of patients, whereas increasing the number of mobilizations did not.
With device-assisted mobilization, patients could be mobilized to standing position early and more frequently. The aim of this pilot study is to test whether mobilization of critically ill patients with ventilatory support using device-assisted mobilization leads to increased mobilization to standing (IMS 4) or beyond.
- Conditions
- Muscle Weakness, Critical Illness
- Being tested
- Device-assisted mobilisation with the sit/stand stabilizer Liana
- Keywords
- ICUAW, Muscle Weakness
- Medical subject headings
- Muscle Weakness, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-assisted mobilisation with the sit/stand stabilizer LianaDevice
Non-invasive device-assisted mobilisation with LIANA
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Mobilization incl. support by the Liana. In the intervention group, Liana is used to train trunk stability in a sitting position. If this is successful, the patient is trained to stand. Mobilization to higher levels is performed according to clinical standards. Receives: Device: Device-assisted mobilisation with the sit/stand stabilizer Liana |
| Control Group | No intervention | Standard of Care without the use of the Liana. In the control group the therapy is carried out according to the ward standard without using the Liana. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mobilisation (IMS)
Mean level of mobilisation measured with the Intensive Car Unit Mobility Scale (IMS) till ICU discharge (or Day 28); IMS ranges from 0 (no mobilization) to 10 (independent walking)
Measured: 28 Days
Secondary outcomes (17)
Frequency of IMS ≥ 4
Frequency of Days with IMS ≥ 4 till ICU discharge (or Day 28)
Measured: 28 Days
Handgrip strength
Muscle strength measured using handgrip strength till ICU discharge (or Day 28)
Measured: 28 Days
MRC Sum Score
Muscle strength measured using Medical Research Council (MRC) Sum Score till ICU discharge (or Day 28); MRC Sum Score ranges from 0 to 60, with 0 worst value
Measured: 28 Days
Diaphragma function
Diaphragm function by diaphragmatic thickening fraction using ultrasound till ICU discharge (or Day 28)
Measured: 28 Days
CPAx Score
The Chelsea Critical Care Physical Assessment Tool (CPAx) during the ICU stay (or till Day 28); ranging from 0 to 50 with 0 the worst score
Measured: 28 Days
Trunk Control Test
Trunk stability using the trunk control test during the ICU stay (or till Day 28)
Measured: 28 Days
Duration of MV
Duration of mechanical ventilation (MV) in days
Measured: 180 Days
Patient satisfaction with VRS
Patient satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 the worst score
Measured: 28 Days
Staff satisfaction with VRS
Staff satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 being worst score
Measured: 28 Days
Staff binding time
Staff binding time for mobilisation during the ICU stay (or Day 28)
Measured: 28 Days
ICU LOS
ICU length of stay in Days
Measured: 180 Days
Hospital LOS
Hospital length of stays
Measured: 180 Days
Time in rehabilitation and hospital
Time in rehabilitation facilities or hospital in days
Measured: 180 Days
(I)ADL
(Intrumental) Activities of Daily Living Score as measured by Iwashyna et al.; range 0-11, 0 the worst
Measured: 180 Days
Disability
Disability measured with the WHODAS 2.0 score
Measured: 180 Days
Quality of life
Quality of life measured with the EQ-5D-5L. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Detail information is available at https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/
Measured: 180 Days
Physical Function
Physical function measured with the Barthel Score, scoring from 0-100 with 0 the worst
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start27 Apr 2023
- Primary completion4 Apr 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan J Schaller, Charite University, Berlin, Germany
- Investigators
- Stefan J Schaller, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716451
- Sponsor's protocol ID
- LIANA-I
- Acronym
- LIANA-I
- Status last verified
- Dec 2025
- First submitted
- 28 Jan 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan is to share deidentified data by reasonable scientific request and after signing an appropriate agreement.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
- ClinicalTrials.gov ID
- NCT05716451
- Acronym / sponsor ID
- LIANA-I / LIANA-I
- Conditions
- Muscle Weakness, Critical Illness
- Keywords
- ICUAW, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 8 Feb 2023 (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 Pilot study will hypothesize that patients with organ insufficiency and breathing assistance in our post-anaesthesia care unit (PACU) and ICU will be mobilized more often to an ICU mobility scale (IMS) ≥ 4 (i.e. standing) using the Liana® mobilizer. Therefore a randomized controlled pilot study will be conducted. The aim is to achieve an important physical function mile stone more often using this device.
Secondary hypotheses are:
- The intervention will relieve the burden of the health care staff in the unit
- The intervention will positively influence the functional outcome of critically ill patients
- The intervention is perceived as positive by the patients
Detailed description
Patients who have been treated in the ICU for a prolonged period of time often have a high degree of immobility. In this context, a state of generalized weakness associated with muscle atrophy (ICUAW) develops in approximately 40% of ICU patients. The severity of generalized weakness may be individual in each patient. It is certain that especially elderly patients and patients with prolonged immobilization have an increased incidence of ICUAW. Symptoms can be highly variable depending on the severity of the course. Some patients report weakness of the extremities to paresis and weakness of the respiratory muscles. Weakness of the respiratory musculature can lead to a prolonged weaning process of mechanical ventilation, prolonging the stay in the ICU. Functional impairments due to ICUAW may also persist many years after the ICU stay. If ICUAW is diagnosed promptly, outcome can be improved by targeted early mobilization. Early mobilization is defined as mobilization in the first 72 h from ICU admission. However, there are numerous barriers to the implementation of early mobilization in critically ill patients, so this remains a major challenge.
Various studies have shown that patients can benefit from a high level of mobilization. For example, Scheffenbichler et al. showed that a high dose of mobilization was associated with increased independence of patients after discharge. The level of mobilization showed positive effects not only in this study, but also in Paton and colleagues. They were able to show that achieving a higher level of mobility (according to the Intensive Care Mobility Scale) was associated with improved outcome at six months. They found that achieving a higher level of mobilization positively affected the health status of patients, whereas increasing the number of mobilizations did not.
With device-assisted mobilization, patients could be mobilized to standing position early and more frequently. The aim of this pilot study is to test whether mobilization of critically ill patients with ventilatory support using device-assisted mobilization leads to increased mobilization to standing (IMS 4) or beyond.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Device-assisted mobilisation with the sit/stand stabilizer LianaMobilization incl. support by the Liana. In the intervention group, Liana is used to train trunk stability in a sitting position. If this is successful, the patient is trained to stand. Mobilization to higher levels is performed according to clinical standards. |
| Control Group | No intervention | –Standard of Care without the use of the Liana. In the control group the therapy is carried out according to the ward standard without using the Liana. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intensive care patient with ventilatory support and an expected intensive care stay of at least another 48 h
- Age ≥ 18 years
- Current length of intensive care stay < 48 h
Key exclusion criteria (13 listed)
- Moribund and critically ill
- Suspected 6-month mortality > 75%.
- Increased intracranial pressure
- Critically ill after cardiopulmonary resuscitation
- Critically ill with primary neuromuscular disease or motor neuron disease
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 |
|---|---|---|
| Device-assisted mobilisation with the sit/stand stabilizer LianaNon-invasive device-assisted mobilisation with LIANA | Device | Intervention Group |
Primary outcome
Level of mobilisation (IMS)
Time frame: 28 Days
Mean level of mobilisation measured with the Intensive Car Unit Mobility Scale (IMS) till ICU discharge (or Day 28); IMS ranges from 0 (no mobilization) to 10 (independent walking)
17 secondary outcomes
Frequency of IMS ≥ 4
Time frame: 28 Days
Handgrip strength
Time frame: 28 Days
MRC Sum Score
Time frame: 28 Days
Diaphragma function
Time frame: 28 Days
CPAx Score
Time frame: 28 Days
Trunk Control Test
Time frame: 28 Days
Duration of MV
Time frame: 180 Days
Patient satisfaction with VRS
Time frame: 28 Days
Staff satisfaction with VRS
Time frame: 28 Days
Staff binding time
Time frame: 28 Days
ICU LOS
Time frame: 180 Days
Hospital LOS
Time frame: 180 Days
Time in rehabilitation and hospital
Time frame: 180 Days
(I)ADL
Time frame: 180 Days
Disability
Time frame: 180 Days
Quality of life
Time frame: 180 Days
Physical Function
Time frame: 180 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. The plan is to share deidentified data by reasonable scientific request and after signing an appropriate agreement.
Related trials for Muscle Weakness
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
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. This study is not recruiting at the moment.
Stefan J Schaller, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device-assisted mobilisation with the sit/stand stabilizer Liana in people with Muscle Weakness and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 15 Dec 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of mobilisation (IMS) (time frame: 28 Days). 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 15 Dec 2025.