Effectiveness of a Novel Scoliosis Therapy Using a Standing Scoliosis Therapy Device With Biological Feedback Mechanism

Overview

This study evaluates the effectiveness of a novel standing scoliosis therapy device with a biofeedback mechanism in children and adolescents with adolescent idiopathic scoliosis (AIS). Participants are assigned to one of three groups: SkolioMaster (prototype device), Skol-As therapy, or the FITS method. The primary objective is to assess whether the device reduces spinal curvature (Cobb angle). Secondary objectives include evaluating its effects on other physical outcomes. Participants will attend rehabilitation sessions twice weekly for six months and undergo clinical and radiographic assessments.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity of unknown etiology that primarily affects children and adolescents during periods of rapid growth. Conservative management aims to prevent curve progression, reduce spinal deformity, and improve functional outcomes while avoiding surgical intervention. This study evaluates a novel standing scoliosis therapy device (SkolioMaster) that integrates passive mechanical correction with active patient-driven correction supported by multimodal biofeedback (visual, auditory, and vibratory). The device is designed to facilitate three-dimensional spinal correction in upright posture, which reflects functional daily conditions and may enhance motor learning and postural control. The trial is a prospective, randomized, controlled study conducted in pediatric patients diagnosed with AIS. Participants aged 8-16 years with a Cobb angle between 10° and 50° and skeletal immaturity (Risser 0-3) are randomly assigned in a 1:1:1 ratio to one of three intervention groups: SkolioMaster therapy (standing biofeedback device), SKOL-AS therapy (device-based therapy in sitting and supine positions with pressure biofeedback), FITS method (physiotherapeutic scoliosis-specific exercises without device use). All participants undergo a 24-week rehabilitation program consisting of individualized sessions twice weekly. Each session includes a structured protocol with warm-up, targeted scoliosis-specific therapy according to group allocation, and a final phase including breathing and relaxation exercises. In the SkolioMaster group, therapy progresses from preparatory exercises in lower positions to standing device-based correction incorporating real-time biofeedback. The primary outcome measure is change in the Cobb angle of the primary spinal curvature assessed on standardized standing anteroposterior radiographs. Secondary outcomes include changes in the Cobb angle of secondary curves, apical vertebral rotation, angle of trunk rotation (ATR), and functional performance assessed using selected EUROFIT tests (trunk strength, upper limb endurance, and speed/agility). Clinical and radiographic assessments are performed at baseline and after completion of the intervention. Outcome assessors and data analysts are blinded to group allocation. The study aims to determine whether therapy using a standing biofeedback-based device provides superior radiological and functional outcomes compared with established physiotherapeutic and device-assisted rehabilitation methods.