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New treatment option for Acquired Brain Injury
Official title Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06469983
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Time post-injury between 28 days and 6 months [1];
- Not recovered upright station;
You likely can't join if
- Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sant'Angelo dei Lombardi, Avellino, Italy
- Telese Terme, BN, Italy
- Milan, Milan, Italy
- Bari, Italy
- Genova, Italy
- Pavia, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sant'Angelo dei Lombardi, Avellino, Italy; Telese Terme, BN, Italy; Milan, Milan, Italy; Bari, Italy; Genova, Italy; Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.