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Completed

NCT Number: NCT05716451

Pilot Study on Device-assisted Mobilisation of Critically Ill Patients

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:

1. The intervention will relieve the burden of the health care staff in the unit 2. The intervention will positively influence the functional outcome of critically ill patients 3. The intervention is perceived as positive by the patients

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Univiversitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Device-assisted mobilisation with the sit/stand stabilizer Liana

Device

Non-invasive device-assisted mobilisation with LIANA

Primary outcomes

  1. 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)

Secondary outcomes

  1. Frequency of IMS ≥ 4

    Time frame: 28 Days

    Frequency of Days with IMS ≥ 4 till ICU discharge (or Day 28)

  2. Handgrip strength

    Time frame: 28 Days

    Muscle strength measured using handgrip strength till ICU discharge (or Day 28)

  3. MRC Sum Score

    Time frame: 28 Days

    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

  4. Diaphragma function

    Time frame: 28 Days

    Diaphragm function by diaphragmatic thickening fraction using ultrasound till ICU discharge (or Day 28)

  5. CPAx Score

    Time frame: 28 Days

    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

  6. Trunk Control Test

    Time frame: 28 Days

    Trunk stability using the trunk control test during the ICU stay (or till Day 28)

  7. Duration of MV

    Time frame: 180 Days

    Duration of mechanical ventilation (MV) in days

  8. Patient satisfaction with VRS

    Time frame: 28 Days

    Patient satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 the worst score

  9. Staff satisfaction with VRS

    Time frame: 28 Days

    Staff satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 being worst score

  10. Staff binding time

    Time frame: 28 Days

    Staff binding time for mobilisation during the ICU stay (or Day 28)

  11. ICU LOS

    Time frame: 180 Days

    ICU length of stay in Days

  12. Hospital LOS

    Time frame: 180 Days

    Hospital length of stays

  13. Time in rehabilitation and hospital

    Time frame: 180 Days

    Time in rehabilitation facilities or hospital in days

  14. (I)ADL

    Time frame: 180 Days

    (Intrumental) Activities of Daily Living Score as measured by Iwashyna et al.; range 0-11, 0 the worst

  15. Disability

    Time frame: 180 Days

    Disability measured with the WHODAS 2.0 score

  16. Quality of life

    Time frame: 180 Days

    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/

  17. Physical Function

    Time frame: 180 Days

    Physical function measured with the Barthel Score, scoring from 0-100 with 0 the worst

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support

Acronym: LIANA-I

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Dec 15, 2025

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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