he Cover Spine Orthosis (CSO) is a novel therapeutic device specifically engineered to address excessive thoracic curvature in individuals diagnosed with hyperkyphosis. Utilizing three-dimensional (3D) printing technology, the orthosis is produced from thermoplastic polyurethane, a material known for its flexibility and durability. The CSO incorporates two primary corrective components positioned anteriorly and posteriorly. The anterior section functions to stabilize the thoracic region from the front, while the posterior section delivers a corrective force from the back, targeting spinal alignment. To ensure a secure and adaptive fit, elastic webbing with Velcro and loop fasteners is integrated on both sides of the shoulder and trunk. These connectors link the anterior and posterior components, maintaining optimal suspension of the orthosis on the user's body. Furthermore, the design features a broad contact area, which enhances postural control by distributing mechanical forces more

The control group was fitted with a semi-rigid thoracolumbar orthosis (SRTLO), a device whose clinical efficacy has been previously validated. This orthosis includes paraspinal support bars, bilateral shoulder straps, and a Velcro-based fastening system. The paraspinal bars function to limit spinal flexion, thereby promoting an extended spinal posture. The shoulder straps are passed anteriorly over the shoulders, routed posteriorly through the axillary regions, crossed to the opposite side, and brought back to the front. Once appropriate tension is applied, the straps are secured using Velcro fasteners. Final stabilization is accomplished by anterior traction on the thoracic section straps to ensure optimal corrective force distribution.

The participants included in the study were asked to use the orthoses given as a result of randomization for four weeks, excluding the time they were asleep (average 12 h per day).

Thoracic kyphosis angle (TKA) was assessed using a flexicurve, a flexible, plastic-coated metal ruler that conforms to the curvature of the spine. For measurement, the flexicurve was molded along the thoracic spine between the C7 and T12 vertebrae while the participant maintained an upright posture. Once the curve was shaped, its outline was transferred onto paper for further analysis. The kyphosis index was calculated by measuring the height of the apex of the curve (B) and dividing it by the total horizontal length of the thoracic curve (X), then multiplying the result by 100: (B/X) × 100. Additionally, the flexicurve angle (θ) was derived by constructing a triangle from the traced curve and measuring the angle formed by lines drawn perpendicular to its sides.

Participant quality of life (QoL) was assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire. This instrument comprises 22 items divided into five distinct domains: pain, self-image, spinal function, mental health, and satisfaction with treatment. Each item is scored on a 5-point likert scale ranging from 1 (least favorable) to 5 (most favorable). Higher total and subscale scores reflect better perceived quality of life, whereas lower scores indicate reduced well-being.