What is this study trying to find out about severe Acquired Brain Injury?

This study is evaluating whether robotic assisted verticalization combined with leg mobilization helps patients with severe Acquired Brain Injury recover better compared to traditional verticalization methods. It aims to understand which approach better supports motor, cognitive, and functional recovery. The research is led by Anna Estraneo and involves multiple centers to improve rehabilitation care.

Who may be eligible for this severe Acquired Brain Injury clinical trial?

Adults aged 18 to 75 years with severe Acquired Brain Injury from various causes may be eligible. Participants need to have stable cognitive or behavioral status assessed over a week and not yet able to stand upright. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this severe Acquired Brain Injury clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. Participants may need to cover their own travel expenses, which are not guaranteed to be reimbursed. You can expect all necessary treatments and assessments during the study to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 75Years

All Genders

ID06469983

Study Comparing Robot-Assisted and Traditional Standing Therapy for Adults With Severe Acquired Brain Injury

Led by Anna Estraneo · Updated on 2025-11-20

118

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of robotic assisted verticalization plus mobilization VEM compared to traditional verticalization TV for patients with severe Acquired Brain Injury sABI. The study focuses on helping patients regain the ability to maintain an upright position, which is crucial for preventing complications from immobility and improving cognitive and muscular function. Prior research shows mixed results due to small or varied patient groups, so this large multicenter study aims to provide clearer evidence using standardized assessments.

CONDITIONS

Brief Title

Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 75 years
Diagnosis of severe Acquired Brain Injury due to traumatic, vascular, anoxic, or mixed causes
Stable behavioral or cognitive diagnosis confirmed by at least 4 evaluations within 1 week
Time since injury between 28 days and 6 months
Unable to maintain upright standing position
Written informed consent from the patient's legal representative or primary caregiver

You will not qualify if you...

Severe medical conditions that prevent verticalization, such as severe hypotension, hemodynamic instability, advanced heart failure, new or worsening arrhythmias, severe liver failure, severe lower limb vascular disease, sepsis or septic shock, recent venous thromboembolism, or severe autonomic dysreflexia
Severe conditions preventing lower limb movement, including fractures or heterotopic ossifications
Severe medical issues affecting EEG activity, such as frequent epileptiform abnormalities
Severe medical conditions affecting consciousness or cognitive status, like severe low sodium or low blood sugar
Contraindications to using the ErigoBasic or ErigoPro devices
Use of prohibited medications or drugs

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Study Comparing Robot-Assisted and Traditional Standing Therapy for Adults With Severe Acquired Brain Injury

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria