Digital therapeutics for mild adolescent idiopathic scoliosis: a protocol for a randomized controlled trial

Abstract

Abstract Background Digital therapeutics (DTx), a new type of intervention presented in the last few years, can be used to provide patients with access to evidence-based therapeutic interventions using high-quality software programs to achieve the purpose of treating, managing, or preventing diseases. The purpose of this study is to explore the efficacy of home-based digital therapy in treating mild adolescent idiopathic scoliosis (AIS). Methods This study will be a prospective, single-blind, randomized controlled, two-arm parallel-group, confirmatory superiority clinical trial. The subjects will include 106 patients aged 10 to 17 years with mild AIS and a major Cobb angle of 10° to 20°. Subjects will be randomly assigned to either a digital therapy group (DTx) or a control group (conventional rehabilitation) for 12 months of treatment. Assessments occur at baseline, 6, and 12 months. Radiographic outcomes will be independently evaluated on anonymized images. The primary outcome is the major Cobb angle. Secondary outcomes are the fall index (FI), forced vital capacity (FVC), and Scoliosis Research Society-22 (SRS-22) score. Data will be analysed using linear mixed-effects models (LMM). Discussion The results of this confirmatory superiority trial will show whether DTx has superior effects on improving spinal deformity, balance function, pulmonary function, and quality of life compared with conventional rehabilitation in patients with mild AIS. Trial registration The trial was registered prospectively at www.chictr.org.cn on September 25th, 2023 (ChiCTR2300076105).