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

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Device: SkolioMaster Biofeedback Standing Scoliosis Therapy Device; Device: SKOL-AS Scoliosis Therapy Device; Behavioral: FITS Physiotherapy (Functional Individual Therapy of Scoliosis)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Polska
    • Chrzanów, Polska, Poland, 32-500
      • Centrum Medyczne Dr Smółka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children and adolescents aged 8 to 16 years
• Diagnosis of adolescent idiopathic scoliosis (AIS)
• Cobb angle between 10° and 50° confirmed on standing spinal radiograph
• Skeletal immaturity defined as Risser sign 0-3
• Ability to participate in physiotherapy sessions
• Written informed consent provided by parent or legal guardian (and assent from the participant when applicable)

Exclusion Criteria:

• Scoliosis of known etiology (e.g., neuromuscular, congenital, syndromic, or metabolic)
• Functional scoliosis
• Age below 8 years or above 16 years
• Lack of consent from participant and/or legal guardian
• Inability to comply with the study protocol or attend regular therapy sessions
• Medical conditions preventing safe participation in rehabilitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SkolioMaster Standing Biofeedback Therapy; Participants receive physiotherapy using the SkolioMaster prototype, a standing scoliosis therapy device integrating passive mechanical correction with active exercises supported by real-time multimodal biofeedback.During the initial phase, participants perform preparatory exercises in lower positions (sitting/supine). Subsequently, therapy is conducted in a standing position using the device. The intervention includes individualized, curve-specific three-dimensional correction involving axial elongation, derotation, and lateral trunk correction. Biofeedback (visual, auditory, and vibratory) is used to guide and optimize motor learning and postural control.	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.
Active Comparator: SKOL-AS Device-Based Therapy; Participants receive physiotherapy using the SKOL-AS device in sitting and supine positions. The intervention combines active and passive scoliosis correction with pressure-based biofeedback provided through air-filled cushions and manometers. Therapy focuses on three-dimensional correction, asymmetrical breathing, and proprioceptive stimulation to promote postural re-education and motor control. Participants attend supervised sessions twice weekly for 24 weeks.	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.
Active Comparator: FITS Physiotherapy (Scoliosis-Specific Exercises); Participants receive physiotherapy based on the Functional Individual Therapy of Scoliosis (FITS) method. This approach involves scoliosis-specific exercises targeting three-dimensional postural correction, muscle activation, and stabilization without the use of therapeutic devices. All exercises are individualized according to curve type and patient functional status and are delivered by certified physiotherapists. Participants attend supervised sessions twice weekly for 24 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb angle of the primary spinal curvature	The Cobb angle is measured on standardized standing anteroposterior spinal radiographs. The primary outcome is the change in the magnitude of the main spinal curvature from baseline to the end of the 24-week intervention period.	Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb angle of the secondary spinal curvature	Assessment of changes in the secondary curve magnitude measured on standing radiographs.	Baseline and 24 weeks
Change in apical vertebral rotation	Rotation of the apical vertebra measured using the Perdriolle method on radiographic images.	Baseline and 24 weeks
Change in angle of trunk rotation (ATR)	Clinical measurement of trunk rotation using a scoliometer during physical examination.	Baseline and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in trunk muscle strength	Assessed using the sit-up test (EUROFIT), measuring trunk muscle strength and endurance (number of repetitions).	Baseline and 24 weeks
Change in upper limb endurance	Assessed using the bent-arm hang test (EUROFIT), measuring duration (seconds).	Baseline and 24 weeks
Change in speed and agility	Assessed using the 10 × 5 m shuttle run test (EUROFIT), measuring time (seconds).	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: Centrum Medyczne Katarzyna Smółka
• Collaborators: Małopolskie Centre of Entrepreneurship
• Investigators: Principal Investigator: Katarzyna Smółka, PhD, Centrum Medyczne Katarzyna Smółka

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: scoliosis; postural correction; pediatric rehabilitation; spinal curvature; biofeedback therapy
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Scoliosis; Spinal Curvatures
• Other Study ID Numbers: ScolioMaster

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No