Actively Recruiting
Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
Led by Anna Estraneo · Updated on 2025-11-20
118
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Anna Estraneo
Lead Sponsor
I
Istituti Clinici Scientifici Maugeri SpA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Severe acquired brain injury due to traumatic, vascular, anoxic, or mixed causes
- Stable behavioral or cognitive diagnosis confirmed by at least 4 evaluations in 1 week
- Time since injury between 28 days and 6 months
- Unable to stand upright
- Written informed consent provided by legal representative or primary caregiver
You will not qualify if you...
- Severe medical conditions preventing safe verticalization (e.g., severe low blood pressure, unstable heart failure, new arrhythmias, severe liver failure, severe blood vessel disease, sepsis, new blood clots, severe autonomic disorders)
- Severe medical issues preventing lower limb movement (e.g., fractures, bone growth abnormalities)
- Medical conditions affecting brain activity on EEG (e.g., frequent epileptic abnormalities)
- Severe conditions affecting consciousness or cognition (e.g., severe low sodium or low blood sugar)
- Contraindications to using the Erigo device as specified by manufacturer
- Use of prohibited drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Avellino, Italy, 83054
Actively Recruiting
2
IRCCS Maugeri Telese Terme
Telese Terme, BN, Italy, 82037
Actively Recruiting
3
IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi
Milan, Milan, Italy, 20148
Actively Recruiting
4
IRCCS Maugeri Bari
Bari, Italy, 70124
Actively Recruiting
5
Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
6
ICS Maugeri
Pavia, Italy, 27100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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