Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness
Condition: Brain Injuries; Disorders of Consciousness
MeSH terms: Brain Injuries; Consciousness Disorders
Study type: Interventional
Phase: Phase 3

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.
    

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).
    

Intervention name(s): Standard physiotherapy; Erigo®Pro group without FES; Erigo®Pro group with FES
Intervention type(s): Behavioral; Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury; stroke; disorders of consciousness; rehabilitation; robotic rehabilitation device