Sanok

Atrial Septal Defect ASD is a type of congenital heart defect that may be closed without open-heart surgery. Traditionally, ASD closure was done surgically, but less invasive options like percutaneous transcatheter occluder devices have become available. This research aims to collect real-world clinical data and confirm the long-term safety and performance of the Lifetech Cera153 ASD Occluder, a device used to close ASD without surgery. The study also seeks to identify any previously unknown side effects of this device. Participants in this study will have received the Lifetech Cera153 ASD Occluder between January 2020 and December 2023, following instructions for use. The study is single-armed and observational, planned under the Regulation EU 2017745. Subjects will be followed up for two years after device implantation to track outcomes and safety. The enrollment period is expected to last about one year with a target of 139 participants. During the study, researchers will monitor procedural success six months after implantation and assess successful closure of the defect immediately after the procedure, at hospital discharge, and at 12 months. They will also track new onset arrhythmias requiring treatment, device or procedure-related adverse events and serious adverse events, as well as any deaths from the time of the procedure up to two years post-implantation. Participants must attend follow-up visits as part of the study, with all data collected and processed with their consent.

Researchers are evaluating the effectiveness of rehabilitation using virtual reality compared with conventional physiotherapy in patients aged 40 to 65 years with chronic low back pain lasting at least three months. This prospective, randomized controlled trial includes 80 participants to reduce variability and assess the impact of virtual reality on physical and psychosocial outcomes in this population. The study focuses on improving movement quality, postural control, and functional mobility while addressing common psychosocial factors such as fear of movement, stress, anxiety, and depression. Participants will be randomly assigned to one of two groups an experimental group receiving conventional rehabilitation combined with non-immersive virtual reality training using the Tecnobody Homing Studio system, and a control group receiving conventional rehabilitation alone. Both groups will complete a standardized four-week rehabilitation program supervised by a physiotherapist. The virtual reality exercises will replace some conventional exercises and provide interactive tasks with visual and auditory biofeedback using a 3D camera for real-time motion analysis. During the study, participants will be assessed at baseline, immediately after the four-week program, and at an eight-week follow-up. Evaluations will include tests of balance, posture, joint mobility, lower limb strength, pain intensity, pressure pain threshold, and psychosocial measures such as kinesiophobia, stress, anxiety, depression, functional disability, quality of life, and motivation for physical activity. Attendance and adherence will be monitored, and any adverse events related to the rehabilitation or virtual reality use will be recorded. The trial aims to provide evidence on virtual reality-assisted rehabilitations role in managing chronic low back pain.