Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial

NCT06469983 | Recruiting

• 1 other identifier: VEM-sABI
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Acquired Brain Injury; Disorder of Consciousness

Keywords

Disorders of Consciousness; rehabilitation; verticalization; robotic

Outcome Measures

Primary Outcomes (1)

• 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

  5 weeks

Secondary Outcomes (5)

• Modified Ashworth scale

  5 weeks - 1 month after treatment

• Medical Research Council Scale

  5 weeks - 1 month after treatment

• modified Barthel Index

  5 weeks - 1 month after treatment

• Disability Rating Scale

  5 weeks - 1 month after treatment

• System Usability Scale

  5 weeks - 1 month after treatment

Other Outcomes (9)

• Spectral metrics

  5 weeks - 1 month after treatment

• Microstate metrics

  5 weeks - 1 month after treatment

• Connectivity metrics

  5 weeks - 1 month after treatment

Study Arms (2)

Robotic Verticalization

EXPERIMENTAL

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®

Traditional Verticalization

ACTIVE COMPARATOR

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

Interventions

ErigoBasic or ErigoPro® DEVICE

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.

Robotic Verticalization

Traditional Verticalization BEHAVIORAL

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)

Traditional Verticalization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years;
• sABI due to traumatic, vascular, anoxic, or mixed etiology;
• Stable behavioral/cognitive diagnosis on at least 4 behavioral evaluations in 1 week using the Italian version of the CRS-R in patients with pDoC, or the LCF-based cognitive assessment in patients with eDoC;
• Time post-injury between 28 days and 6 months \[1\];
• Not recovered upright station;
• Written informed consent by the patient's legal rep-resentative/primary caregiver.

You may not qualify if:

• Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe symptomatic heart failure with reduced ejection fraction, cardiac arrhythmia of new diagnosis or arrhythmic flare, severe hepatic failure, chronic severe lower limb arterio-venous disease, sep-sis/septic shock, thrombus venous embolism of new diag-nosis, severe autonomic dysreflexia);
• Severe medical conditions hampering lower limb mobili-zation (e.g., fractures, heterotopic ossifications);
• Severe medical conditions impacting EEG activity (e.g., sub-continuous or abundant EEG epileptiform abnormali-ties);
• Severe medical conditions influencing conscious-ness/cognitive status, such as severe hyponatremia or hy-poglycemia;
• Contraindications to the use of Erigo®Basic and/or Eri-go®Pro (Hocoma, Volketswil, Switzerland) as per technical data sheet (see Appendix A);
• Presence of prohibited drugs

Sponsors & Collaborators

• Anna Estraneo: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Ospedale Policlinico San Martino: collaborator

Study Sites (6)

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

RECRUITING

IRCCS Maugeri Telese Terme

Telese Terme, BN, 82037, Italy

RECRUITING

IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi

Milan, Milan, 20148, Italy

RECRUITING

IRCCS Maugeri Bari

Bari, 70124, Italy

RECRUITING

Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

ICS Maugeri

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double blind could not be applicable since a physical therapist could be blinded due to the nature of the intervention (VEM or SV). However, clinical evaluation will be performed by an examiner blind to the patient' group of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)