Robotic Assisted Early Mobilization in Ventilated ICU Patients

NCT ID: NCT04423796

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2022-09-12

Brief Summary

Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.

Conditions

Critical Illness Polyneuromyopathy; Critical Illness; Early Ambulation; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic assisted early mobilization

Robotic assisted early mobilization started within 72 hours of ICU admission.

Group Type: EXPERIMENTAL

Robotic-assisted early mobilization

Intervention Type: DEVICE

The early mobilization is done by robotic assistance devices.

Early mobilization

Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.

Group Type: ACTIVE_COMPARATOR

Early mobilization

Intervention Type: OTHER

Early mobilization by health care professionals without robotic assistance.

Interventions

Robotic-assisted early mobilization

The early mobilization is done by robotic assistance devices.

Intervention Type: DEVICE

Early mobilization

Early mobilization by health care professionals without robotic assistance.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Invasive mechanically ventilated and expected to be ventilated for another 24 hours
• Cardiovascular stability, allowing mobilization
• Respiratory stability, allowing mobilization

Exclusion Criteria

• Bed-bound before ICU admission
• Bed-rest order or contraindication of weight load of the lower extremity or spine
• Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
• Fresh SAB, ICB or elevated ICP
• Status epilepticus
• Acute intoxication
• Shock with catecholamine doses >0.3µg/kg/min or acute bleeding including organ ruptures
• Multiorgan failure with lactate > 4 mmol/l
• Body height outside the range 150-195 cm
• Body weight outside the range 45-135 kg
• pAVK IV°
• Pacemakers or other electrical stimulators
• Implanted medical pumps
• Pregnancy
• Life expectancy below 7 days or acute palliative care situation
• Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
• Unable to understand the official language
• ICU stay > 72h at the time of enrolment

Translated with www.DeepL.com/Translator (free version)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reactive Robotics GmbH

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan J Schaller

Deputy Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, Germany

Countries

Germany

References

Lorenz M, Langer N, Kloss P, Maechler M, Bald A, Warner L, Fuest K, Weiss B, Schaller SJ. ROBotic-assisted Early Mobilization in ventilated surgical critically ill patients (ROBEM-I)-A randomized, controlled, outcome-assessor-blinded pilot study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101549. doi: 10.1016/j.accpm.2025.101549. Epub 2025 May 23.

Reference Type: DERIVED

PMID: 40414562 (View on PubMed)

Other Identifiers

ROBEM I

Identifier Type: -

Identifier Source: org_study_id