RESILIENT Brace for Idiopathic Scoliosis

(RESILIENT Trial)

This trial tests a new scoliosis brace called the RESILIENT brace to determine its effectiveness in preventing spinal curves from worsening in children with idiopathic scoliosis (a type of spine curve with no known cause). Researchers aim to assess whether the brace can prevent the curve from progressing past 35 degrees, its initial corrective ability, and its comfort and ease of use in daily life. The trial seeks participants aged 9-16 with a specific type of scoliosis curve who have not previously used a brace or undergone surgery. Participants will wear the brace daily, attend regular check-ups, and complete surveys about their experiences. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance scoliosis treatment for future patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research shows that scoliosis braces, such as the RESILIENT brace, are generally easy for patients to use. Studies have found that these braces can effectively improve the curve of the spine in many cases when worn as instructed. In these studies, the braces did not cause any major health problems. Most side effects are minor, such as discomfort while wearing the brace. Some teenagers may feel self-conscious or stressed about wearing a brace, but this is common with many types of braces.

The RESILIENT Brace for idiopathic scoliosis is unique because it incorporates embedded sensors that measure force and wear time, which is a significant advancement over traditional rigid braces. Unlike standard options like the Boston or Milwaukee braces, which are often bulky and uncomfortable, the RESILIENT Brace is designed to be semi-rigid, low-profile, and adjustable, potentially increasing comfort and compliance among patients. Researchers are excited about this treatment because these features could lead to better patient adherence and more effective management of scoliosis.

Research has shown that wearing a brace can help treat adolescent idiopathic scoliosis (AIS), a curve in the spine. Studies have found that brace treatment can prevent worsening in about 76% of these spinal curves. One study found that bracing can improve the spinal curve in nearly 20% of patients when the brace fits well and is worn correctly. The success of bracing often depends on wearing it as directed, which means using it consistently and properly. Overall, braces have effectively slowed down or stopped the worsening of spine curvature in many patients. In this trial, participants will be fitted with the RESILIENT Scoliosis Brace System, a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time.¹⁴⁵⁶⁷