Abstract
In recent years, the prevalence of acquired brain injury (ABI) has been on the rise, leading to impaired gait functionality in affected individuals. Traditional gait exoskeletons are typically rigid and bilateral and lack adaptability. To address this, the STELO, a pioneering modular gait-assistive device, was developed. This device can be externally configured with joint modules to cater to the diverse impairments of each patient, aiming to enhance adaptability and efficiency. This study aims to assess the safety and usability of the initial functional modular prototype, STELO, in a sample of 14 ABI-diagnosed participants. Adverse events, device adjustment assistance and time, and gait performance were evaluated during three sessions of device use. The results revealed that STELO was safe, with no serious adverse events reported. The need for assistance and time required for device adjustment decreased progressively over the sessions. Although there was no significant improvement in walking speed observed after three sessions of using STELO, participants and therapists reported satisfactory levels of comfort and usability in questionnaires. Overall, this study demonstrates that the STELO modular device offers a safe and adaptable solution for individuals with ABI, with positive user and therapist feedback.