Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness
EriCOS
1 other identifier
interventional
47
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2016
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
December 24, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedAugust 13, 2019
August 1, 2019
3.2 years
December 22, 2015
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recovery of consciousness
Time to improve 1 diagnostic consciousness category in the Coma Recovery Scale - Revised (CRS-R)
4 weeks
Secondary Outcomes (4)
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
Study Arms (3)
Control group standard physiotherapy
ACTIVE COMPARATORPatients 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.
Erigo®Pro group without FES
ACTIVE COMPARATORPatients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device but without functional electrical stimulation (FES) of the leg muscles.
Erigo®Pro group with FES
ACTIVE COMPARATORPatients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device including functional electrical stimulation (FES) of the leg muscles.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Informed consent provided by legal representative of patient
- unresponsive wakefulness syndrome (UWS) or minimal conscious state (MCS), defined by CRS-R
- acquired brain injury as reason for disorder of consciousness
You may not qualify if:
- pre-existing coma, UWS, or MCS
- permanent sedation and/or analgesia with continuous i.v.-application
- body weight \> 135 kg
- length of leg of less than 75 cm or more than 100 cm
- contractures in leg joints
- unstable fractures
- open wounds / severe skin irritations on the leg
- severe heart failure or unstable arrhythmias
- aggressive / uncooperative behavior
- other medical reasons for strict bed rest
- severe arterial occlusion disease of the legs
- cardiac pacer
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- Therapiezentrum Burgaucollaborator
Study Sites (2)
Therapiezentrum Burgau
Burgau, Bavaria, 89331, Germany
Department of Neurology, University of Munich
Munich, Bavaria, 81377, Germany
Related Publications (1)
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.
PMID: 36536249DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Bender, Prof.Dr.
Ludwig-Maximilians - University of Munich
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
December 22, 2015
First Posted
December 24, 2015
Study Start
January 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08