Pilot Study on Device-assisted Mobilisation of Critically Ill Patients

NCT05716451 | Completed

• 1 other identifier: LIANA-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The aim is to achieve an important physical function mile stone more often using this device. Secondary hypotheses are:

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

Conditions

Muscle Weakness; Critical Illness

Keywords

ICUAW; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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)

  28 Days

Secondary Outcomes (17)

• Frequency of IMS ≥ 4

  28 Days

• Handgrip strength

  28 Days

• MRC Sum Score

  28 Days

• Diaphragma function

  28 Days

• CPAx Score

  28 Days

Study Arms (2)

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.

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.

Interventions

Device-assisted mobilisation with the sit/stand stabilizer Liana DEVICE

Non-invasive device-assisted mobilisation with LIANA

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes

Study Officials

• Stefan J Schaller, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: April 27, 2023
• Primary Completion: April 4, 2025
• Study Completion: November 11, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

DE (1)