CompletedNot Applicable

Pilot Study on Device-assisted Mobilisation of Critically Ill Patients

Germany40 participantsStarted 2023-04-27

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of mobilisation (IMS)

Timeframe: 28 Days

Trial details

NCT IDNCT05716451

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-04

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