The Efficacy of Trunk Bracing With an Instrumented Corrective Exercise on Spinal Deformity, Pulmonary Function, Trunk Muscle Endurance, and Quality of Life in Adolescent Idiopathic Scoliosis: Protocol for a Parallel Groups Clinical Study
Authors: Rezaeian Zeinab , Andalib Ali , Bokaee Fateme , Poorpooneh Najafabadi Maryam , Yeowell Gillian , Sadeghi-Demneh Ebrahim 
Published: November 2022

Background
Adolescent idiopathic scoliosis is a 3D spine distortion with an unidentified etiology. It results in noticeable trunk deformity, decreased muscle strength and endurance at the trunk, changes in chest volume, breathing issues, and ultimately a decline in the quality of life. Trunk bracing and corrective exercises make up most of the treatment of patients with scoliosis when their deformity is between 20° and 45°, and they have not yet attained skeletal maturity. Evidence suggests that spinal deformity in people with scoliosis may result from improper motor control. Automatic response training is an exercise therapy technique that can modify the pattern of trunk muscle control for supporting the spinal column in normal alignment. An apparatus called a cantilever device is required for this type of exercise, which facilitates training at home. In spite of research showing the benefit of braces and therapeutic exercise in adolescents with scoliosis, less emphasis has been given to the impact of home-based training, especially when this intervention is paired with braces.

Objective
We aim to compare the efficacy of bracing and a conventional exercise program to a combination treatment that includes trunk bracing and exercises with a cantilever device performed at home on the degree of spine curvature, pulmonary function, trunk muscular endurance, and quality of life.

Methods
This study was a 2-arms parallel-group clinical study. A total of 16 adolescents with idiopathic scoliosis and single lumbar and thoracolumbar curves of 20°-45° were recruited and randomly assigned into 2 groups. Group A received a combination of trunk bracing and exercise using an instrument known as a “cantilever.” Group B (controls) received trunk bracing and a conventional exercise program (without a tool). The study outcomes were the Cobb angle of the scoliotic curve, pulmonary function, the endurance of the trunk muscles, and quality of life. The study outcomes were measured at 2 time points: before the intervention (T1) and 12 weeks following the start of the intervention (T2; at this time, the intervention period has been completed). Multivariate analysis of variance was used to test between- and within-group differences.

Results
Recruitment for this study began in fall 2022 and is expected to be completed by the end of summer 2023.

Conclusions
We studied the efficacy of a combined trunk bracing program and postural response exercises using a cantilever device in treating adolescent idiopathic scoliosis and compared it with trunk bracing and conventional home exercises. Exercises performed at home using a cantilever device are anticipated to raise the endurance of trunk muscles, which will help reduce trunk deformity, enhance pulmonary function, and improve the quality of life of participants.

Trial Registration
Iranian Registry of Clinical Trials IRCT20220330054371N1; https://www.irct.ir/trial/62811

International Registered Report Identifier (IRRID)
PRR1-10.2196/43265