Ergonomic brace wear for adolescent idiopathic scoliosis (AIS)

Abstract

In this study, ergonomic brace wear for AIS is designed and developed based on clinical applications, materials science, and garment technology, with the aim to control spinal deformity, reduce the possibility of spinal curve progression, and address the needs of patients as well as taking into consideration their psychological concerns. In order to prevent the progression of spinal deformity, a 3-point pressure system and traction force is applied through the ergonomic brace wear by strategically inserting rigid components, like pre-shaped SMAs and paddings. The straps can exert additional corrective and compression forces onto the torso and spine. Also, the seamless design allows the brace to be worn next to the skin, which also helps to reduce the brace weight, offer a softer touch, and prevent uncomfortable markings. Bonding and ultrasonic welding technologies are applied to eliminate the seams and stitches in the brace wear. Therefore, compared to conventional bracing treatment, the new ergonomic brace wear is more aesthetically pleasing and comfortable, so that the compliance with brace treatment can be improved. In total, 31 subjects were invited to participate, with 21 subjects completing the clinical study. 12 subjects tried first prototype of the Ergonomic brace. It has no significant improvement in Cobb angles when comparing with hard brace. Nine subjects tried the second prototype by adding curved SMA struts. Among these subjects, four of them have >5° improvement, and five of them have <5° improvement. Significant differences (P<0.05) were found between out-brace and in-brace Cobb’s angle in both non-parametric tests and paired T-tests. The design patent was filed in China, and the results have been communicated in the Annals of Biomedical Engineering journal, at three conferences, and at The Global Healthcare Innovation Academy (GHIA) exhibition.