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

Summary

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.

Conditions

• Idiopathic Scoliosis

Interventions

DEVICE

SkolioMaster Biofeedback Standing Scoliosis Therapy Device

The SkolioMaster is a prototype standing scoliosis therapy device designed to provide three-dimensional spinal correction through a combination of passive mechanical forces and active patient-driven exercises supported by real-time biofeedback. The system incorporates adjustable thoracic and lumbar correction modules, pelvic stabilization, axial elongation support, and integrated sensors (pressure, strain gauges) delivering visual, auditory, and vibratory feedback. Therapy is individualized based on curve type and includes axial elongation, trunk derotation, and lateral correction performed in an upright position. Participants initially perform preparatory exercises in lower positions, followed by progressive training using the standing device. Sessions are conducted twice weekly for 24 weeks, each lasting approximately 60 minutes.

DEVICE

SKOL-AS Scoliosis Therapy Device

The SKOL-AS is a device-assisted physiotherapy system used in sitting and supine positions, combining active and passive correction of spinal deformity. The intervention utilizes air-filled cushions with pressure-based biofeedback (manometers) to guide asymmetrical breathing and corrective movements. Therapy focuses on three-dimensional spinal correction, proprioceptive stimulation, and postural re-education through controlled pressure application and patient engagement. Sessions are conducted twice weekly for 24 weeks, each lasting approximately 60 minutes.

BEHAVIORAL

FITS Physiotherapy (Functional Individual Therapy of Scoliosis)

The FITS method is a physiotherapeutic scoliosis-specific exercise program based on individualized three-dimensional correction principles. The intervention includes active exercises targeting postural correction, trunk stabilization, muscle balance, and motor control without the use of therapeutic devices. Exercises are tailored to the patient's curvature pattern and functional status and are delivered by certified physiotherapists. Sessions are conducted twice weekly for 24 weeks, each lasting approximately 60 minutes.

Sponsors & Collaborators

• Małopolskie Centre of Entrepreneurship

  collaborator UNKNOWN

• Centrum Medyczne Katarzyna Smółka

  lead OTHER

Principal Investigators

• Katarzyna Smółka, PhD · Centrum Medyczne Katarzyna Smółka

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-05

Primary Completion

2023-03-17

Completion

2023-04-14

Countries

• Poland

Study Locations