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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Atrial Septal Defect (ASD) is a type of congenital heart defect that can potentially be treated without open-heart surgery. Traditionally, ASD closure has been done surgically, but percutaneous transcatheter occluder devices offer a less invasive alternative. This research evaluates the Lifetech Cera™ ASD Occluder, a device designed for non-surgical closure of ASD, aiming to collect real-world clinical data and confirm its long-term safety and performance while identifying any unknown side effects. The study is a multi-center, single-arm post-market clinical follow-up involving patients who have already received the Lifetech Cera™ ASD Occluder device between January 1, 2020, and December 31, 2023. About 139 participants will be enrolled and followed for a total of 24 months after implantation. This follow-up will provide important information on the procedural success and ongoing safety of the device. Participants will be monitored through scheduled follow-up visits to assess the device's performance and any complications. Researchers will collect clinical data, including procedural success measured at 6 months post-implantation. The total study duration includes an enrollment period of approximately one year and a two-year follow-up post-implantation, ensuring long-term safety monitoring and data collection.

All Genders
6 locations
V

Actively Recruiting

Researchers are evaluating the effectiveness of rehabilitation using virtual reality compared with conventional physiotherapy in adults aged 40 to 65 years with chronic low back pain lasting at least three months. This prospective randomized controlled trial includes 80 participants and aims to address both physical and psychosocial factors such as pain, postural control, kinesiophobia, stress, anxiety, and depression, which impact functional ability and quality of life. The study seeks to provide evidence on whether integrating virtual reality into rehabilitation can improve movement quality and patient engagement compared to standard physiotherapy. Participants will be randomly assigned to one of two groups for a four-week rehabilitation program. The experimental group will receive conventional rehabilitation combined with non-immersive virtual reality training using the Tecnobody Homing Studio system, which offers interactive exercises with visual and auditory feedback to improve postural control, coordination, and functional mobility. The control group will receive conventional rehabilitation alone, consisting of therapeutic exercises focused on spinal mobility, core stability, balance, and lower limb function. The virtual reality sessions replace a portion of standard exercises to keep total therapy time similar between groups. Throughout the study, assessments will be conducted at baseline, after the four-week program, and at an eight-week follow-up. Participants will undergo tests measuring balance, posture, joint mobility, muscle strength, pain intensity, pressure pain threshold, body composition, and psychosocial factors like kinesiophobia and stress. Therapy adherence will be tracked by recording attendance, and safety monitoring will include observing any adverse events related to virtual reality use. The study's outcome measures aim to evaluate lasting effects on motor and psychosocial function in this patient population.

Age: 40Years - 65YearsAll GendersPhase Not Applicable
1 location