Comparing robotic and traditional methods for helping patients with severe brain injuries stand up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of robotic-assisted verticalization compared to traditional verticalization methods for patients with severe acquired brain injury (sABI). The study involves a multicenter approach, focusing on patients who are in a prolonged disorder of consciousness and have not yet recovered the ability to stand. Participants will undergo rehabilitation that includes exercises aimed at facilitating their recovery to an upright position, which is crucial for preventing complications associated with immobility. The trial aims to determine if robotic assistance can enhance the rehabilitation process and improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

• Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
  Sant'Angelo dei Lombardi, Avellino, Italy Recruiting
• IRCCS Maugeri Bari
  Bari, Bari, Italy Recruiting
• IRCCS Maugeri Telese Terme
  Telese Terme, Bn, Italy Recruiting
• Ospedale Policlinico San Martino
  Genova, Genova, Italy Recruiting
• IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi
  Milan, Milan, Italy Recruiting
• ICS Maugeri
  Pavia, Pavia, Italy Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Caregivers and patients with severe brain injury: using the SAFE scale to monitor behavior together

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• Web-based therapy for cognitive and speech rehabilitation in hospital

  This project will try delivering cognitive and speech therapy through a web-based platform called Cognishine for adults in hospital after stroke or other acquired brain injury.

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• Sensor robot-assisted therapy for kids with brain injury

  This trial tests Inrobics Rehab, a robot-assisted home and clinic therapy, to see if it helps children aged 7-16 with acquired brain injury improve motor, thinking, and social skills while being easy to use.

  Recruiting Inrobics Social Robotics, S.L. · Madrid, Madrid · NCT07448103

• Acoustic and breathing tests for dysarthria after acquired brain injury

  This study will see if combining voice recordings, breathing tests, and a clinical speech check can help identify the type and severity of dysarthria in adults after an acquired brain injury.

  Recruiting University of Salamanca · Salamanca, Salamanca · NCT07435155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.