Comparing robotic and traditional methods for helping patients with severe brain injuries stand up
Multicentric Study on Combined Verticalization and Mobilization in Patients With Severe Acquired Brain Injury: A Randomized Controlled Trial
This study is testing if using robots to help patients with severe brain injuries stand up is better than traditional methods for their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 6 sites (Sant'Angelo dei Lombardi, Avellino and 5 other locations) |
| Trial ID | NCT06469983 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with prolonged disorder of consciousness who are 28 days to 6 months post-injury and have not yet recovered the ability to stand.
Not a fit: Patients with severe medical conditions that affect their ability to participate in verticalization or those with significant mobility restrictions due to fractures or other complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation outcomes and quality of life for patients with severe brain injuries.
How similar studies have performed: Other studies have shown promise in using robotic assistance for rehabilitation, but this specific approach is relatively novel in the context of severe acquired brain injury.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sant'Angelo dei Lombardi, Avellino and 5 other locations
- Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS — Sant'Angelo dei Lombardi, Avellino, Italy (Recruiting)
- IRCCS Maugeri Telese Terme — Telese Terme, Bn, Italy (Recruiting)
- IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi — Milan, Milan, Italy (Recruiting)
- IRCCS Maugeri Bari — Bari, Italy (Recruiting)
- Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- ICS Maugeri — Pavia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.