NCT02639481|CompletedPhase 3
Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness
EriCOS
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EriCOS
Sponsor study identifier
interventional
47
1 country
2
Study Start
January 2016
Actual (reported)Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)Patients with acquired brain injury (ABI) often suffer from severe disorders of consciousness (DOC), such as coma, unresponsive wakefulness syndrome (UWS), or minimally conscious state (MCS). This study examines the effect, a novel robotic rehabilitation device (the Erigo®Pro system) has on the recovery of consciousness of DOC patients. The device enables patients to be verticalized very early during acute neurorehabilitation and includes robotic leg movement training as well as functional electrical stimulation (FES) of leg nerves. Patients will be randomly allocated to one of three treatment groups: (i) control group with standard physiotherapy without the device, (ii) device treatment without FES, and (iii) device treatment with FES. Time until recovery of consciousness, rehabilitation outcome, and amount of complications will be the outcome variables.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2015
Actual (reported)December 24, 2015
Actual (reported)January 2016
Actual (reported)March 2019
Actual (reported)March 2019
Actual (reported)Time to recovery of consciousness
Time to improve 1 diagnostic consciousness category in the Coma Recovery Scale - Revised (CRS-R)
4 weeks
Independence in the activities of daily living
6 months
Degree of spasticity
4 weeks
Occurrence of typical neurorehabilitation complications
4 weeks
Change in bioelectrical brain activity
4 weeks
Patients will receive standard physiotherapy for 60 minutes, including the goal of verticalization and stimulation of the patient but without the use of the robotic Erigo®Pro device.
Patients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device but without functional electrical stimulation (FES) of the leg muscles.
Classical standard physiotherapy, including measures to verticalize patients by means of orthesis, classical tilt tables, or castings
Use of the Erigo®Pro device to verticalize patients to above 60° while performing robotic stepping leg movements. FES ist not used.
Therapiezentrum Burgau
Burgau, Bavaria, 89331, Germany
Department of Neurology, University of Munich
Munich, Bavaria, 81377, Germany
Rosenfelder MJ, Helmschrott VC, Willacker L, Einhaupl B, Raiser TM, Bender A. Effect of robotic tilt table verticalization on recovery in patients with disorders of consciousness: a randomized controlled trial. J Neurol. 2023 Mar;270(3):1721-1734. doi: 10.1007/s00415-022-11508-x. Epub 2022 Dec 19.
Andreas Bender, Prof.Dr.
Ludwig-Maximilians - University of Munich
47 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2015
First Posted
December 24, 2015
Study Start
January 2016
Actual (reported)Neuromonitoring in Patients During Aortic Valve Replacement
Patients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device including functional electrical stimulation (FES) of the leg muscles.
Use of the Erigo®Pro device to verticalize patients to above 60° while performing robotic stepping leg movements. FES is applied during then whole treatment session, providing electrical stimulation to the muscles of the upper and lower leg, synchronous to the robotic stepping movements
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)Last Updated
August 13, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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