Robotic Assisted Early Mobilization in Ventilated ICU Patients

NCT04423796 | Completed

• 1 other identifier: ROBEM I
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Early mobilization; pilot trial; feasibility trial; robotic assisted

Outcome Measures

Primary Outcomes (1)

• Feasibility of early mobilization

  Frequency of early mobilization performed by one health care provider during mechanical ventilation

  Up to Day 5

Secondary Outcomes (12)

• Mobilization level

  up to Day 5

• Mobilization duration

  up to Day 5

• Frequency of mobilization

  up to Day 5

• Pain level

  up to Day 5

• Anxiety

  up to Day 5

Study Arms (2)

Robotic assisted early mobilization

EXPERIMENTAL

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

Device: Robotic-assisted early mobilization

Early mobilization

ACTIVE COMPARATOR

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

Other: Early mobilization

Interventions

Robotic-assisted early mobilization DEVICE

The early mobilization is done by robotic assistance devices.

Robotic assisted early mobilization

Early mobilization OTHER

Early mobilization by health care professionals without robotic assistance.

Early mobilization

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Reactive Robotics GmbH: collaborator

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 40414562 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Stefan J Schaller, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director

Model Details: Randomized, controlled, parallel-group, open label pilot trial

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 9, 2020
• Study Start: November 13, 2020
• Primary Completion: August 14, 2022
• Study Completion: September 12, 2022
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publishing results.
• Access Criteria: Data will be shared to other researchers on reasonable request.

Locations

DE (1)