Analysis of the Effectiveness of a Novel Scoliosis Therapy in Children and Adolescents Using a Standing Scoliosis Therapy Device With a Biological Feedback Mechanism

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.