An interventional study of ErigoBasic or ErigoPro® and Traditional Verticalization in Acquired Brain Injury and Disorder of Consciousness, sponsored by Anna Estraneo. Recruiting at 6 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Anna Estraneo · Not applicable, Interventional, and Treatment
In the rehabilitation project for patients with severe Acquired Brain Injury (sABI), it is essential to include exercises that facilitate the recovery of the upright position (or verticalization). Recently, tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase. The present multicentre study aims at evaluating the effectiveness of robotic assisted verticalization plus mobilization (VEM) versus traditional verticalization (TV) in a large cohort of patients with sABI.
Background Italian Consensus on rehabilitation of patients with severe acquired brain injury (sABI) and recent American Academy of Neurology guidelines on patients with sABI and prolonged disorder of consciousness (pDoC) provided recommendations for admission of such complex disabled patients to inpatient specialized rehabilitation units with high expertise on multidisciplinary care.
In such dedicated settings (in Italy named as high specialty rehabilitation for sABI, Cod 75) a comprehensive standard rehabilitation programme includes positioning, prolonged passive range of motion exercises, and splinting protocols to prevent or remediate neuromuscular complications (contractures, spasticity, and heterotopic ossifications). Simultaneously, basic multi-sensory stimulation or targeted cognitive training should be implemented for facilitating cognitive functioning recovery. In the rehabilitation project for patients with sABI, it is essential to include exercises that facilitate the recovery of the upright position (or verticalization), in order to prevent secondary complications from immobility (e.g., stasis pneumonias, deep vein thrombosis), to facilitate the stabilization of the haemodynamic balance (known to be altered in this population after the acute event), to promote the improvement of cognitive performance (especially vigilance and attention), and to improve the muscular-cutaneous trophism. Verticalization with traditional tilt-table training can show several adverse events: no leg movements during tilt-table verticalization lead to limited musculoskeletal and cardiovascular response; 2. pooling of blood in the lower extremities which can lead to a drop of the central blood and hypotension; 3. It requires substantial modification of cardiovascular therapy due to presyncope symptoms.
More recently, tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase. However, contrasting, and inconclusive effects of controlled verticalization on functionality, gait/balance and level of consciousness in patients with sABI have been found, likely because of the limited methodological quality of the available clinical trials. All studies present some concerns such as small cohorts or heterogeneous cohorts of patients with sABI (e.g., chronic patients with sequelae of sABI) or the randomization process is not described.
The present multicentre study aims at overcoming these limitations evaluating the effectiveness of robotic assisted verticalization versus traditional verticalization (TV) in a large cohort of patients with sABI. Standardized and validated clinical tools will be used for evaluating effect on patient's motor, cognitive and functional performances. Additional markers will be used as outcome measures for investigating possible brain plasticity. Neurophysiological findings (e.g., EEG background activity and reactivity and quantitative EEG metrics) and blood biomarkers have been correlated to cognitive performance and assist prognostication in patients with sABI and pDoC34,. Brain-derived neurotrophic factor, BDNF, a neurotrophin involved in neurogenesis and synaptic plasticity can be upregulated by physical exercise. However, a recent study showed that BDNF serum levels do not change after robotic assisted verticalization in patients with pDoC. Neurofilament light chain, NF-L, a marker of primary and secondary neurodegeneration in sABI was linked to long-term axonal degeneration and poor outcome. Glial fibrillary acid protein, GFAP, a filament protein is related to brain function recovery.
Methods 118 patients will be randomized to receive either VEM or TV at the same period of the day throughout the experiment. In the week before starting study protocol, the VEM and TV groups will undergo a preliminary "tolerance session test" of gradual verticalization (starting from 10 min and then progression toward 30 min).
The study protocol will involve 5 VEM or 5 TV sessions per week for 4 weeks (total 20 sessions). Each daily VEM or SR session last 30 minutes.
VEM protocol and parameters: Erigo® gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance. The Erigo verticalization is coupled with the rhythmic passive movement of the lower limbs ensuring the more normal range of motion (ROM) and the alternation of loading and unloading of the lower limbs, based on patient's osteo-articular condition (e.g., ROM=45°; cadence=min. 24 steps per minute).
TV protocol: consists in gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance, using a traditional standing device (i.e., non-robotic traditional tilt table) Both groups received an additional 60 minute-comprehensive daily (60 minutes) rehabilitation programme in the 3 months of the study. This programme consists of alternate bed positioning, passive limbs mobilization, activities to increase arousal (e.g., multisensory stimulation), language and swallowing therapy based on patient's functional condition.
Primary endpoint Level of Cognitive Functioning, LCF Secondary endpoints Modified Ashworth scale, MAS; Muscle Research Council, MRC (EpDoC) pDoC reflex movement to nociceptive stimulation (pDoC); Disability Rating Scale, DRS; Adverse Events Report (AER)+Agitation Behavior Scale and Nociception Coma Scale respectively; System Usability Scale (SUS); modified Barthel Index (mBI).
Exploratory endpoints Coma Recovery-Scale Revised, CRS-R (in pDoC) EEG architecture (e.g., microstates, functional connectivity, and complexity measures) Blood biomarkers (i.e., BDNF, NF-L, and GFAP); Fondazione Don Gnocchi-Clinical Complications Scale, FDG-CCS.
Adverse Events Report (weekly from enrolment through termination of RV or TV protocol). During VEM session Heart rate (HR), mean arterial pressure (MAP), oxygen saturation (SaO2), agitation, and pain will be monitored. Additionally, agitation and pain will be measured by the Agitation Behavior Scale and Nociception Coma Scale respectively.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 118 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Anna Estraneo is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Erigo® gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance. The Erigo verticalization is coupled with the rhythmic passive movement of the lower limbs ensuring the more normal range of motion (ROM) and the alternation of loading and unloading of the lower limbs, based on patient's osteo-articular condition (e.g., ROM=45°; cadence=min. 24 steps per minute).
Device: ErigoBasic or ErigoPro®
gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance, using a traditional standing device (i.e., non-robotic traditional tilt table)
Behavioral: Traditional Verticalization
Static bed with integrated robotic stepper (ErigoBasic) and optionally integrated with Functional Electrical Stimulation (FES ErigoPro®). The Erigo is a robot designed to be used for early functional mobilisation of patients with neurological manifestations or who are bedridden, even in intensive care. It is a tilt table equipped with an integrated passive stepper controlled by microprocessors that generate physiological leg movements: the patient's thighs are secured by straps to the movement mechanisms and the feet are secured to plates equipped with shock absorbers, while the upper body is held in place by a sling integrated into the table. Erigo provides active functions: gradual elevation in orthostatism up to 90°, controlled and independent mobilisation of the lower limbs, and functional stimulation.
gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance, using a traditional standing device (i.e., non-robotic traditional tilt table)
Levels of cognitive functioning
A clinical scale assessing global cognitive functioning in patients emerged from a disorder of consciousness. Higher scores indicate a higher cognitive functioning
Time frame: 5 weeks
Modified Ashworth scale
A clinical scale assessing spasticity. Higher scores indicate a more severe spasticity
Time frame: 5 weeks - 1 month after treatment
Medical Research Council Scale
A clinical scale assessing muscle functioning. Higher scores indicating a better functioning
Time frame: 5 weeks - 1 month after treatment
modified Barthel Index
It is a measure of functional disability, with higher scores indicating higher functional independence
Time frame: 5 weeks - 1 month after treatment
Disability Rating Scale
It is a measure of functional disability, with higher scores indicating higher disability
Time frame: 5 weeks - 1 month after treatment
System Usability Scale
It is a measure of usability and compliance. Higher scores indicate a better performance
Time frame: 5 weeks - 1 month after treatment
Spectral metrics
Measure of quantitative EEG. Higher values indicate a better functional connectivity
Time frame: 5 weeks - 1 month after treatment
Microstate metrics
Measure of quantitative EEG. Higher values indicate a better functional connectivity
Time frame: 5 weeks - 1 month after treatment
Connectivity metrics
Measure of quantitative EEG. Higher values indicate a better functional connectivity
Time frame: 5 weeks - 1 month after treatment
Brain-derived neurotrophic factor
Blood biomarker. Higher value indicate higher brain plasticity
Time frame: 5 weeks - 1 month after treatment
Neurofilament-Light
Blood biomarker. Higher value indicate higher brain plasticity
Time frame: 5 weeks - 1 month after treatment
Glial fibrillary acidic protein
Blood biomarker. Higher value indicate higher brain plasticity
Time frame: 5 weeks - 1 month after treatment
Fondazione Don Gnocchi-Clinical Complications Scale
A clinical scale assessing clinical complications. Higher scores indicate more and more severe clinical complications
Time frame: 5 weeks - 1 month after treatment
Coma Recovery Scale-Revised total score
A clinical scale assessing the level of consciousness in patients with disorders of consciousness. Higher scores indicate a higher level of consciousness
Time frame: 5 weeks - 1 month after treatment
Levels of cognitive functioning
A clinical scale assessing global cognitive functioning in patients emerged from a disorder of consciousness. Higher scores indicate a higher cognitive functioning
Time frame: 1 month after treatment
Plan to share: No — A plan for wide dissemination of the results will be activated at the beginning, during and at the end of the project, through presentations at national and international conferences, and newsletters of scientific societies in the rehabilitation, neurological, and neuropsychological fields, to ensure that the results are shared with the scientific community. At the end of the project, the analysed results will be the subject of scientific publications in national and international peer-reviewed journals. The project will also be presented at regular conferences involving stakeholders (clinicians, patient and family associations) in accordance with the dissemination plan of the pnrr Fit4Med project.
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