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

August 12, 2019 updated by: Andreas Bender, Ludwig-Maximilians - University of Munich
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Burgau, Bayern, Germany, 89331
        • Therapiezentrum Burgau
      • Munich, Bayern, Germany, 81377
        • Department of Neurology, University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to recovery of consciousness
Time Frame: 4 weeks
Time to improve 1 diagnostic consciousness category in the Coma Recovery Scale - Revised (CRS-R)
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
6 months
Degree of spasticity
Time Frame: 4 weeks
Degree of spasticity, measured with the modified Ashworth Scale (mAS)
4 weeks
Occurrence of typical neurorehabilitation complications
Time Frame: 4 weeks
Do pneumonias and pressure ulcers occur in a patient (clinical observation)?
4 weeks
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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Therapiezentrum Burgau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Bender, Prof.Dr., Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 560-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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