NCT06469983 Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
| NCT ID | NCT06469983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anna Estraneo |
| Condition | Acquired Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2024-12-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06469983 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acquired Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06469983 currently recruiting?
Yes, NCT06469983 is actively recruiting participants. Visit ClinicalTrials.gov or contact Anna Estraneo to inquire about joining.
Where is the NCT06469983 trial being conducted?
This trial is being conducted at Sant'Angelo dei Lombardi, Italy, Telese Terme, Italy, Milan, Italy, Bari, Italy and 2 additional locations.
Who is sponsoring the NCT06469983 clinical trial?
NCT06469983 is sponsored by Anna Estraneo. The trial plans to enroll 118 participants.