COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04750265

Stefan J Schaller, MD

stefan.schaller@charite.de

2021-02-11

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

- 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

2

Charite University, Berlin, Germany

18

100

Germany

Critical disease at enrollment

8: Critical disease at enrollment

20

Level of mobilization;Level of mobilization

None

Not reported

[{"arm_notes": "", "treatment_id": 1127, "treatment_name": "Robotic assisted early mobilization", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]