Robotic Vs. Traditional Verticalization in Patients with Severe Acquired Brain Injury: a Randomized Controlled Trial

Launched by ANNA ESTRANEO · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help patients with severe acquired brain injury (sABI) learn to stand up or get into an upright position. One method uses a robotic device that helps move the lower limbs, while the other is the traditional way of helping patients stand. The goal is to see which method is more effective for patients who are currently unable to stand on their own after their injury.

To be eligible for this study, patients need to have a stable diagnosis of a disorder of consciousness, meaning they may have some awareness but are not fully alert, and they should be between 28 days to 6 months post-injury. They also need to have consent provided by themselves or their primary caregiver. Participants can expect to be part of a larger group of patients and will receive either the robotic or traditional method to help them stand. This study aims to improve rehabilitation practices for patients with brain injuries, making it an important step in their recovery journey.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Stable clinical diagnosis of pDoC based on repeated Coma Recovery Scale -revised, CRS-R, or emerged from DoC (Level of Cognitive Functioning, LCF ≥4)
• • Time post-injury 28 days- 6 months ;
• • non-recovered upright station
• • Signed informed consent by the patient or by the patient's primary caregiver.
• Exclusion Criteria:
• • Severe medical conditions influencing clinical diagnosis and EEG activity (e.g., sub-continuous or abundant EEG epileptiform discharges) or hampering verticalization (e.g., severe hypotension or cardio-vascular instability) or lower limb mobilization (e.g., fractures, heterotopic ossifications).