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Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness (EriCOS)

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ClinicalTrials.gov Identifier: NCT02639481
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Therapiezentrum Burgau
Information provided by (Responsible Party):
Andreas Bender, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Brain Injuries Disorders of Consciousness Behavioral: Standard physiotherapy Device: Erigo®Pro group without FES Device: Erigo®Pro group with FES Phase 3

Detailed Description:

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). These DOC can be temporary or persistent. Verticalization and multisensory stimulation are traditionally important therapeutic principles in the neurorehabilitation of such patients. These principles have not yet been tested in randomized controlled trials yet. This trial will therefore evaluate the effect that a 4 week training with a verticalization device (the Erigo®Pro system) with integrated repetitive robotic leg movements and functional electrical stimulation of the leg muscles (FES) has on the clinical course of DOC patients in an inpatient neurorehabilitation setting, following acute ABI. 156 patients will be randomized 1:1:1 to one of the following groups: (i) control group without the Erigo®Pro, (ii) treatment with the Erigo®Pro without FES, and (iii) treatment with the Erigo®Pro and simultaneous FES. There will be 4 training sessions per week for 4 weeks with each session being 60 minutes in length. This will be part of the standard neurorehabilitation program, which in Germany comprises 300 minutes of therapy per day. Patients in the active treatment groups ii) and iii) are required to be verticalized above 60° for at least 35 minutes per treatment session. Patients in the control group will be treated with conventional methods, including verticalization by therapists but without the help of the device. FES will be conducted with the following parameters: 8 channels covering the major ventral and dorsal muscles of the upper and lower, initial current 10 milli ampere (mA), pulse with 250 micro seconds (µs), frequency 25 herz (Hz), ramp 3. Current will be gradually increased to the motor threshold plus 20%.

The investigators will test the following hypotheses:

  1. Treatment with the Erigo®Pro system will lead to a quicker recovery of consciousness (increase of at least one diagnostic category of the CRS-R) than conventional therapy,
  2. Treatment with the Erigo®Pro system including FES will lead to a quicker recovery of consciousness than using the Erigo®Pro without FES, 3).) Treatment with the Erigo®Pro system will decrease spasticity and complications of neurorehabilitation (pneumonia, pressure ulcers) than conventional therapy, and

4.) Treatment with the Erigo®Pro system will lead to an improved longterm patient outcome (6 months) with regard to independence in the activities of daily living, compared to conventional therapy.

The main outcome variable is the Coma Recovery Scale - revised (CRS-R), secondary variables are the Functional Independence Measure (FIM), the Nociception Coma Scale (NCS), the Modified Ashworth Scale for spasticity, and quantitative HD-EEG measures for brain activity (power, variability, entropy).

Study visits will be prior to first treatment (t0), during the first treatment in vertical position (t1), directly following the first treatment in horizontal patient positioning (t2), 2 weeks after the first treatment (halfway through treatment protocol, t3), at the end of the final treatment after weeks (t4), and final outcome measurement, 6 months after the patient inclusion (t5) within the patients living environment (nursing home or home).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Arm Intervention/treatment
Active Comparator: Control group standard physiotherapy
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.
Behavioral: Standard physiotherapy
Classical standard physiotherapy, including measures to verticalize patients by means of orthesis, classical tilt tables, or castings

Active Comparator: Erigo®Pro group without FES
Patients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device but without functional electrical stimulation (FES) of the leg muscles.
Device: Erigo®Pro group without FES
Use of the Erigo®Pro device to verticalize patients to above 60° while performing robotic stepping leg movements. FES ist not used.

Active Comparator: Erigo®Pro group with FES
Patients will receive 60 minutes of therapy with the robotic Erigo®Pro verticalization device including functional electrical stimulation (FES) of the leg muscles.
Device: Erigo®Pro group with FES
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




Primary Outcome Measures :
  1. Time to recovery of consciousness [ Time Frame: 4 weeks ]
    Time to improve 1 diagnostic consciousness category in the Coma Recovery Scale - Revised (CRS-R)


Secondary Outcome Measures :
  1. Independence in the activities of daily living [ Time Frame: 6 months ]
    How independent are patients 6 months after study inclusion, measured by the Functional Independence Measure (FIM)

  2. Degree of spasticity [ Time Frame: 4 weeks ]
    Degree of spasticity, measured with the modified Ashworth Scale (mAS)

  3. Occurrence of typical neurorehabilitation complications [ Time Frame: 4 weeks ]
    Do pneumonias and pressure ulcers occur in a patient (clinical observation)?

  4. Change in bioelectrical brain activity [ Time Frame: 4 weeks ]
    Does treatment lead to increased bioelectrical brain activity, measured by high density EEG (power, variability, entropy)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639481


Locations
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Germany
Therapiezentrum Burgau
Burgau, Bayern, Germany, 89331
Department of Neurology, University of Munich
Munich, Bayern, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Therapiezentrum Burgau
Investigators
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Principal Investigator: Andreas Bender, Prof.Dr. Ludwig-Maximilians - University of Munich

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Responsible Party: Andreas Bender, Professor of Neurology, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02639481     History of Changes
Other Study ID Numbers: 560-15
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Andreas Bender, Ludwig-Maximilians - University of Munich:
traumatic brain injury
stroke
disorders of consciousness
rehabilitation
robotic rehabilitation device
Additional relevant MeSH terms:
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Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders