Idiopathic ScoliosisNCT07585110
Effectiveness of a Novel Scoliosis Therapy Using a Standing Scoliosis Therapy Device With Biological Feedback Mechanism
A study testing SkolioMaster Biofeedback Standing Scoliosis Therapy Device, SKOL-AS Scoliosis Therapy Device and FITS Physiotherapy (Functional Individual Therapy of Scoliosis) in people with Idiopathic Scoliosis, run by Centrum Medyczne Katarzyna Smółka at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- SkolioMaster Biofeedback Standing Scoliosis Therapy Device, SKOL-AS Scoliosis Therapy Device and FITS Physiotherapy (Functional Individual Therapy of Scoliosis)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jul 2021to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- SkolioMaster Biofeedback Standing Scoliosis Therapy Device, SKOL-AS Scoliosis Therapy Device, FITS Physiotherapy (Functional Individual Therapy of Scoliosis)
- Keywords
- scoliosis, pediatric rehabilitation, biofeedback therapy, spinal curvature, postural correction
- Medical subject headings
- Scoliosis, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkolioMaster Biofeedback Standing Scoliosis Therapy DeviceDevice
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.
SKOL-AS Scoliosis Therapy DeviceDevice
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.
FITS Physiotherapy (Functional Individual Therapy of Scoliosis)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: FITS Physiotherapy (Functional Individual Therapy of Scoliosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks
Secondary outcomes (3)
Change in Cobb angle of the secondary spinal curvature
Assessment of changes in the secondary curve magnitude measured on standing radiographs.
Measured: Baseline and 24 weeks
Change in apical vertebral rotation
Rotation of the apical vertebra measured using the Perdriolle method on radiographic images.
Measured: Baseline and 24 weeks
Change in angle of trunk rotation (ATR)
Clinical measurement of trunk rotation using a scoliometer during physical examination.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start5 Jul 2021
- Primary completion17 Mar 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrum Medyczne Katarzyna Smółka
- Sponsor type
- University, hospital or other
- Collaborators
- Małopolskie Centre of Entrepreneurship
- Responsible party
- Sponsor
- Investigators
- Katarzyna Smółka, PhD, Principal investigator, Centrum Medyczne Katarzyna Smółka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585110
- Sponsor's protocol ID
- ScolioMaster
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of a Novel Scoliosis Therapy in Children and Adolescents Using a Standing Scoliosis Therapy Device With a Biological Feedback Mechanism
- ClinicalTrials.gov ID
- NCT07585110
- Acronym / sponsor ID
- ScolioMaster
- Conditions
- Idiopathic Scoliosis
- Keywords
- scoliosis, pediatric rehabilitation, biofeedback therapy, spinal curvature, postural correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centrum Medyczne Katarzyna SmółkaUniversity, hospital or other
- Collaborators
- Małopolskie Centre of Entrepreneurship
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SkolioMaster Standing Biofeedback Therapy | Experimental | Device: SkolioMaster Biofeedback Standing Scoliosis Therapy DeviceParticipants 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. |
| SKOL-AS Device-Based Therapy | Active comparator | Device: SKOL-AS Scoliosis Therapy DeviceParticipants 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. |
| FITS Physiotherapy (Scoliosis-Specific Exercises) | Active comparator | Behavioral: FITS Physiotherapy (Functional Individual Therapy of Scoliosis)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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkolioMaster Biofeedback Standing Scoliosis Therapy DeviceThe 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 | SkolioMaster Standing Biofeedback Therapy |
| SKOL-AS Scoliosis Therapy DeviceThe 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. | Device | SKOL-AS Device-Based Therapy |
| 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. | Behavioural | FITS Physiotherapy (Scoliosis-Specific Exercises) |
Primary outcome
Change in Cobb angle of the primary spinal curvature
Time frame: Baseline and 24 weeks
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.
3 secondary outcomes
Change in Cobb angle of the secondary spinal curvature
Time frame: Baseline and 24 weeks
Change in apical vertebral rotation
Time frame: Baseline and 24 weeks
Change in angle of trunk rotation (ATR)
Time frame: Baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Smółka, PhD principal investigator
Centrum Medyczne Katarzyna Smółka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkolioMaster Biofeedback Standing Scoliosis Therapy Device, SKOL-AS Scoliosis Therapy Device and FITS Physiotherapy (Functional Individual Therapy of Scoliosis) in people with Idiopathic Scoliosis, run by Centrum Medyczne Katarzyna Smółka at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb angle of the primary spinal curvature (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.