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

NCT07585110 | Completed

• 1 other identifier: ScolioMaster
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

scoliosis; pediatric rehabilitation; biofeedback therapy; spinal curvature; postural correction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Cobb angle of the secondary spinal curvature

  Baseline and 24 weeks

• Change in apical vertebral rotation

  Baseline and 24 weeks

• Change in angle of trunk rotation (ATR)

  Baseline and 24 weeks

Other Outcomes (3)

• Change in trunk muscle strength

  Baseline and 24 weeks

• Change in upper limb endurance

  Baseline and 24 weeks

• Change in speed and agility

  Baseline and 24 weeks

Study Arms (3)

SkolioMaster Standing Biofeedback Therapy

EXPERIMENTAL

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

SKOL-AS Device-Based Therapy

ACTIVE COMPARATOR

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

FITS Physiotherapy (Scoliosis-Specific Exercises)

ACTIVE COMPARATOR

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)

Interventions

SkolioMaster Biofeedback Standing Scoliosis Therapy Device 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.

SkolioMaster Standing Biofeedback Therapy

SKOL-AS Scoliosis Therapy Device 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.

SKOL-AS Device-Based Therapy

FITS Physiotherapy (Functional Individual Therapy of Scoliosis) BEHAVIORAL

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.

FITS Physiotherapy (Scoliosis-Specific Exercises)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centrum Medyczne Katarzyna Smółka: lead
• Małopolskie Centre of Entrepreneurship: collaborator

Study Sites (1)

Centrum Medyczne Dr Smółka

Chrzanów, Polska, 32-500, Poland

Location

MeSH Terms

Conditions

Scoliosis; Spinal Curvatures

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Katarzyna Smółka, PhD

  Centrum Medyczne Katarzyna Smółka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1:1 ratio to one of three intervention groups: SkolioMaster (standing biofeedback device), SKOL-AS (device-based therapy in sitting and supine positions), or FITS (physiotherapeutic scoliosis-specific exercises). Each group follows a distinct therapeutic protocol for 24 weeks, with supervised sessions conducted twice weekly. Outcomes are compared between groups to evaluate the relative effectiveness of the interventions.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: July 5, 2021
• Primary Completion: March 17, 2023
• Study Completion: April 14, 2023
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)