Comparing Virtual Reality and Traditional Cognitive Training for Brain Injury Rehabilitation
Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
This study tests whether using virtual reality for brain injury rehabilitation helps people improve their thinking skills and daily activities better than traditional training methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 3 sites (Sant'Angelo dei Lombardi, Avellino and 2 other locations) |
| Trial ID | NCT06474871 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a non-immersive Virtual Reality (VR) rehabilitation system compared to traditional cognitive training in patients with severe acquired brain injury. It aims to address gaps in existing literature by focusing on a diverse patient population and employing a randomized controlled trial design. Participants will engage in rehabilitation activities designed to enhance executive functions and daily living skills through VR technology, which may offer increased motivation and engagement. The study will include multiple centers to ensure a robust sample size and generalizable results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a stable clinical diagnosis of severe acquired brain injury, who are within 28 days to 6 months post-injury.
Not a fit: Patients with severe medical conditions that hinder participation or those with prior neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive rehabilitation outcomes for patients with severe acquired brain injury.
How similar studies have performed: Previous studies have shown promise in using VR for rehabilitation in stroke patients, but this approach in a broader ABI context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * LCF ≥4 at study entry; * Age 18-75 * Stable clinical diagnosis (i.e., stable LCF); * Time post-injury between 28 days and 6 months; * Ability to complete the pre-test A section of the Italian version of the Trail Making Test (TMT); * A pathological B-A score of the TMT according to normative data adjusted for age and education; * Signed informed consent by the patient or by the patient's primary caregiver. Exclusion Criteria: * Severe medical conditions that might hamper participation in the rehabilitation sessions, or influence diagnosis; * Previous neurodegenerative or acquired neurological diseases that affect cognitive domains (e.g., dementia)
Where this trial is running
Sant'Angelo dei Lombardi, Avellino and 2 other locations
- Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS — Sant'Angelo dei Lombardi, Avellino, Italy (Recruiting)
- ICS Maugeri — Telese Terme, Benevento, Italy (Recruiting)
- IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS — Milan, 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.