Safety and Effectiveness of New Textile Braces to Treat Adolescent Idiopathic Scoliosis in Girls Aged 10 to 14

What this Trial Is About

Adolescent idiopathic scoliosis AIS is a common three-dimensional spinal deformity in youths with unknown causes, where spinal curvature tends to worsen during puberty. This research evaluates anisotropic textile braces designed to improve spinal correction and reduce curve progression in AIS, addressing limitations of traditional rigid braces that can be uncomfortable and visually unappealing to teenagers. The study aims to provide a more comfortable and psychologically acceptable alternative while considering the needs of patients. The anisotropic textile braces use a combination of rigid, semi-rigid, and flexible materials to provide several correction mechanisms axial elongation with textile composites fitted closely to the trunk, 3-point pressure using semi-rigid pads, elastic bands to correct kyphosis or lordosis, uneven straps for derotation between pelvis and shoulders, and sensors that actively help maintain correct posture. Participants will wear these braces for 12 to 18 months, instructed to wear them 23 hours per day. Health evaluations including heart, lung function, and sensory tests will be performed at the start. Participants will undergo clinical assessments, radiographic imaging, and self-report measures throughout the study and follow-up after completion. The primary outcome is the progression of the spinal curve measured over 18 months, while secondary outcomes include posture improvement. The study lasts up to 18 months per participant and monitors safety and adherence to the brace protocol, with the goal of improving scoliosis management in adolescents.

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis