Idiopathic ScoliosisSchrothMEDNCT06875661
Treatment of Adolescent Idiopathic Scoliosis with the Schroth Method
A study testing Schroth in people with Idiopathic Scoliosis, run by University of Novi Sad at 1 site in Serbia.
Trial summary
This study investigates the effectiveness of the Schroth method, a conservative physiotherapeutic approach, in the treatment of adolescent idiopathic scoliosis (AIS). AIS is a three-dimensional spinal deformity of unknown etiology that develops during growth, affecting 2-3% of the general population. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Schroth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Mar 2023to 10 May 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of idiopathic scoliosis; Age range of 10-18 years (adolescent); Cobb angle greater than 10; No other types of exercise, medical treatment.
Who cannot join
- The existence of some contraindications for exercise, psychological problems, neuro-logical-muscular diseases; Previous spine surgery.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
University of Novi Sad, Faculty of Sport and Physical Education
Novi Sad, 21000
About this study
Official title: Treatment of Adolescent Idiopathic Scoliosis with the Conservative Schroth Method: a Randomized Controlled Trial
This study investigates the effectiveness of the Schroth method, a conservative physiotherapeutic approach, in the treatment of adolescent idiopathic scoliosis (AIS). AIS is a three-dimensional spinal deformity of unknown etiology that develops during growth, affecting 2-3% of the general population. While most cases are mild, some require medical intervention, including bracing or surgery. Conservative treatments, such as specific exercise programs, aim to slow progression, improve postural alignment, and enhance respiratory function. Among these, the Schroth method is widely recognized for its structured approach, emphasizing active three-dimensional posture correction, rotational breathing, and sensorimotor training.
This study was designed as a randomized, single-blind, parallel-group trial conducted at Scolio Centar in Novi Sad between March and August 2023. Ethical approval was obtained from the Faculty of Sports and Physical Education, University of Novi Sad, and informed consent was secured from participants' parents. Inclusion criteria comprised a confirmed AIS diagnosis, an age range of 10-18 years, a Cobb angle greater than 10°, and no prior surgical or alternative treatment. Exclusion criteria included contraindications for exercise, psychological disorders, neuromuscular diseases, or previous spinal surgeries.
Read more
The study involved 34 participants who were randomly assigned to two groups: an experimental group (EG), which underwent supervised Schroth therapy three times a week for eight weeks, and a control group (CG), which performed the same exercises independently at home. Baseline and post-intervention assessments included radiographic measurement of Cobb angle, ATR via scoliometer, respiratory function tests (VC, FVC, FEV1, FEV1/FVC ratio) using spirometry, and CE via manual measurement. Stratified randomization was used to balance the groups based on Cobb angle severity.
The Schroth exercise protocol included posture correction exercises, spinal stabilization drills, and targeted breathing techniques, supervised by a certified physiotherapist for the EG. The CG received initial instruction but performed the exercises independently at home.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spine that develops between 10 years of age and skeletal maturity. It is characterized by lateral curvature, vertebral rotation, and sagittal plane changes. Despite extensive research, the exact etiology remains unknown, though genetic factors are believed to play a significant role. AIS affects 2-3% of the general population, with 10% of diagnosed individuals requiring some form of intervention, and 0.1% progressing to surgical treatment. The primary concerns in AIS management include curve progression, respiratory dysfunction, postural imbalance, and potential pain syndromes.
Conservative treatments aim to prevent scoliosis progression, reduce spinal deformity, and improve overall function. The most commonly used conservative approaches include the Schroth method, the Scientific Exercise Approach to Scoliosis (SEAS), the Lyon method, and core stabilization exercises. The Schroth method, developed by Katharina Schroth in the 1920s and refined over decades, is a structured physiotherapeutic approach that combines active three-dimensional posture correction, rotational breathing, and postural awareness training. It is widely used to improve spinal alignment, muscular symmetry, and pulmonary function in AIS patients.
Several studies have demonstrated the benefits of Schroth exercises, showing improvements in Cobb angle, trunk rotation, and respiratory function. However, there is ongoing debate regarding the efficacy of supervised therapy compared to self-administered home-based programs. This study aims to determine the effectiveness of supervised Schroth exercises in AIS patients and compare outcomes between supervised and unsupervised intervention groups.
Study Design This study was a randomized, single-blind, 1:1 parallel-group trial conducted at Scolio Centar in Novi Sad between March and August 2023. Ethical approval was obtained from the Ethics Committee of the Faculty of Sports and Physical Education, University of Novi Sad. Written informed consent was obtained from the parents of all participants before enrollment.
Participants
A total of 34 participants (24 males, 10 females) aged 11-16 years with AIS were recruited. Inclusion criteria included:
Diagnosis of AIS Age between 10 and 18 years Cobb angle >10° Risser sign between 0 and 5 No prior scoliosis treatment, including bracing or surgery
Exclusion criteria included:
Contraindications for exercise (e.g., cardiovascular or orthopedic limitations) Neuromuscular diseases Psychological conditions interfering with participation Prior spinal surgery Randomization and Blinding Participants were randomly assigned to either the experimental group (EG) or the control group (CG) using stratified randomization based on Cobb angle severity. Allocation was performed using sealed envelopes. The primary investigator conducting assessments was blinded to group allocation to reduce bias.
Intervention The intervention lasted eight weeks and consisted of three weekly sessions of 90 minutes each for the EG, performed under the supervision of Schroth-certified physiotherapists. The CG received an initial supervised training session on Schroth exercises and was instructed to perform the same exercises at home without further supervision.
The Schroth method includes:
Postural correction: Active realignment of the spine to reduce scoliosis curvature Rotational breathing: Directing inhaled air towards concave regions of the thorax to enhance spinal symmetry Muscle activation and stabilization: Strengthening targeted muscle groups to support spinal correction
The Schroth exercise protocol consisted of:
Warm-up exercises (general mobilization and activation)
Specific scoliosis correction exercises, including:
Side bending in a sitting position Derotation exercises in supine and prone positions Shoulder counter-traction exercises Core stabilization drills Breathing exercises targeting lung expansion and thoracic mobility Final stretching and relaxation exercises Outcome Measures
Baseline and post-treatment assessments were conducted for the following outcomes:
Cobb Angle (°): Measured via standing anterior-posterior radiographs Angle of Trunk Rotation (ATR) (°): Assessed using a Bunnell scoliometer in the forward bending position Vital Capacity (VC) (L): Measured using a Spirolab portable spirometer Forced Vital Capacity (FVC) (L): Evaluated through spirometry Forced Expiratory Volume in One Second (FEV1) (L): Determined via spirometry FEV1/FVC Ratio: Expressed as a percentage to assess airway function Chest Expansion (CE) (cm): Measured manually at the sternum-xiphoid junction using a tape measure
- Conditions
- Idiopathic Scoliosis
- Being tested
- Schroth
- Keywords
- Schroth method, Adolescent idiopathic scoliosis, Cobb angle, Spine health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SchrothOther
Patients in the experimental group exercised for 90 minutes a day, three days a week. Schroth exercises were performed in an asymmetrical position to improve the symmetry of the trunk. These exercises include stretching, flexion, spinal lengthening, derotation, strengthening, and rotational breathing exercises. The respondents combined these exercises with everyday life activities. In the control group, subjects were taught Schroth exercises under the supervision of an authorized physiotherapist, and they were asked to practice the exercises as regularly as possible at home.
| Study group | Role | What they receive |
|---|---|---|
| Schroth | Experimental | Schroth experimental group Receives: Other: Schroth |
| Control | No intervention | Group of participants without Schroth method intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cobb angle
The Coob angle expressed in degrees, was obtained using a standard anterior-posterior standing radiograph of the complete spine .
Measured: 8 weeks
Angle of trunk rotation
The angle of trunk rotation (ATR) was measured with a Bunnell scoliometer, in a forward bending standing position. The scoliometer was placed on the patient's back cen-trally over the spine. ATR is expressed in degrees.
Measured: 8 weeks
Vital Capacity (VC)
Vital Capacity (VC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.
Measured: 8 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy) and present maximum amount of air a person can forcibly exhale after taking a deep breath The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values in liters.
Measured: 8 weeks
Forced Expiratory Volume in One Second (FEV1)
Forced Expiratory Volume in One Second (FEV1) is the amount of air a person can forcibly exhale in the first second of a forced breath after taking a deep inhalation. Measuring using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.
Measured: 8 weeks
Chest expansion
Chest expansion was measured manually using a tape marked in millimeters. Chest expansion was measured at the junction between the xiphoid process and the body of the sternum and expressed in centimeters.
Measured: 8 weeks
Secondary outcomes (5)
Date of birth
The participant's date of birth is collected in order to calculate his age in years.
Measured: 8 weeks
Height
The height of the subject is determined in meters.
Measured: 8 weeks
Weight
The weight of the participants is analyzed in kilograms.
Measured: 8 weeks
Gender
The sex of the participants is recorded at the start of the study.
Measured: 8 weeks
Body Mass Index (BMI)
The participant's BMI is calculated from his height and weight.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Mar 2023
- Primary completion1 May 2023
- Study completion10 May 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dragan Marinkovic, University of Novi Sad
- Investigators
- Dragan Marinkovic, Msc, Principal investigator, University of Novi Sad, Faculty of Sport and Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875661
- Sponsor's protocol ID
- 49-02-04/2023-1
- Acronym
- SchrothMED
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in scoliosis. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adolescent Idiopathic Scoliosis with the Conservative Schroth Method: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06875661
- Acronym / sponsor ID
- SchrothMED / 49-02-04/2023-1
- Conditions
- Idiopathic Scoliosis
- Keywords
- Schroth method, Adolescent idiopathic scoliosis, Cobb angle, Spine health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 13 Mar 2025 (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 investigates the effectiveness of the Schroth method, a conservative physiotherapeutic approach, in the treatment of adolescent idiopathic scoliosis (AIS). AIS is a three-dimensional spinal deformity of unknown etiology that develops during growth, affecting 2-3% of the general population. While most cases are mild, some require medical intervention, including bracing or surgery. Conservative treatments, such as specific exercise programs, aim to slow progression, improve postural alignment, and enhance respiratory function. Among these, the Schroth method is widely recognized for its structured approach, emphasizing active three-dimensional posture correction, rotational breathing, and sensorimotor training.
This study was designed as a randomized, single-blind, parallel-group trial conducted at Scolio Centar in Novi Sad between March and August 2023. Ethical approval was obtained from the Faculty of Sports and Physical Education, University of Novi Sad, and informed consent was secured from participants' parents. Inclusion criteria comprised a confirmed AIS diagnosis, an age range of 10-18 years, a Cobb angle greater than 10°, and no prior surgical or alternative treatment. Exclusion criteria included contraindications for exercise, psychological disorders, neuromuscular diseases, or previous spinal surgeries.
The study involved 34 participants who were randomly assigned to two groups: an experimental group (EG), which underwent supervised Schroth therapy three times a week for eight weeks, and a control group (CG), which performed the same exercises independently at home. Baseline and post-intervention assessments included radiographic measurement of Cobb angle, ATR via scoliometer, respiratory function tests (VC, FVC, FEV1, FEV1/FVC ratio) using spirometry, and CE via manual measurement. Stratified randomization was used to balance the groups based on Cobb angle severity.
The Schroth exercise protocol included posture correction exercises, spinal stabilization drills, and targeted breathing techniques, supervised by a certified physiotherapist for the EG. The CG received initial instruction but performed the exercises independently at home.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spine that develops between 10 years of age and skeletal maturity. It is characterized by lateral curvature, vertebral rotation, and sagittal plane changes. Despite extensive research, the exact etiology remains unknown, though genetic factors are believed to play a significant role. AIS affects 2-3% of the general population, with 10% of diagnosed individuals requiring some form of intervention, and 0.1% progressing to surgical treatment. The primary concerns in AIS management include curve progression, respiratory dysfunction, postural imbalance, and potential pain syndromes.
Conservative treatments aim to prevent scoliosis progression, reduce spinal deformity, and improve overall function. The most commonly used conservative approaches include the Schroth method, the Scientific Exercise Approach to Scoliosis (SEAS), the Lyon method, and core stabilization exercises. The Schroth method, developed by Katharina Schroth in the 1920s and refined over decades, is a structured physiotherapeutic approach that combines active three-dimensional posture correction, rotational breathing, and postural awareness training. It is widely used to improve spinal alignment, muscular symmetry, and pulmonary function in AIS patients.
Several studies have demonstrated the benefits of Schroth exercises, showing improvements in Cobb angle, trunk rotation, and respiratory function. However, there is ongoing debate regarding the efficacy of supervised therapy compared to self-administered home-based programs. This study aims to determine the effectiveness of supervised Schroth exercises in AIS patients and compare outcomes between supervised and unsupervised intervention groups.
Study Design This study was a randomized, single-blind, 1:1 parallel-group trial conducted at Scolio Centar in Novi Sad between March and August 2023. Ethical approval was obtained from the Ethics Committee of the Faculty of Sports and Physical Education, University of Novi Sad. Written informed consent was obtained from the parents of all participants before enrollment.
Participants
A total of 34 participants (24 males, 10 females) aged 11-16 years with AIS were recruited. Inclusion criteria included:
Diagnosis of AIS Age between 10 and 18 years Cobb angle >10° Risser sign between 0 and 5 No prior scoliosis treatment, including bracing or surgery
Exclusion criteria included:
Contraindications for exercise (e.g., cardiovascular or orthopedic limitations) Neuromuscular diseases Psychological conditions interfering with participation Prior spinal surgery Randomization and Blinding Participants were randomly assigned to either the experimental group (EG) or the control group (CG) using stratified randomization based on Cobb angle severity. Allocation was performed using sealed envelopes. The primary investigator conducting assessments was blinded to group allocation to reduce bias.
Intervention The intervention lasted eight weeks and consisted of three weekly sessions of 90 minutes each for the EG, performed under the supervision of Schroth-certified physiotherapists. The CG received an initial supervised training session on Schroth exercises and was instructed to perform the same exercises at home without further supervision.
The Schroth method includes:
Postural correction: Active realignment of the spine to reduce scoliosis curvature Rotational breathing: Directing inhaled air towards concave regions of the thorax to enhance spinal symmetry Muscle activation and stabilization: Strengthening targeted muscle groups to support spinal correction
The Schroth exercise protocol consisted of:
Warm-up exercises (general mobilization and activation)
Specific scoliosis correction exercises, including:
Side bending in a sitting position Derotation exercises in supine and prone positions Shoulder counter-traction exercises Core stabilization drills Breathing exercises targeting lung expansion and thoracic mobility Final stretching and relaxation exercises Outcome Measures
Baseline and post-treatment assessments were conducted for the following outcomes:
Cobb Angle (°): Measured via standing anterior-posterior radiographs Angle of Trunk Rotation (ATR) (°): Assessed using a Bunnell scoliometer in the forward bending position Vital Capacity (VC) (L): Measured using a Spirolab portable spirometer Forced Vital Capacity (FVC) (L): Evaluated through spirometry Forced Expiratory Volume in One Second (FEV1) (L): Determined via spirometry FEV1/FVC Ratio: Expressed as a percentage to assess airway function Chest Expansion (CE) (cm): Measured manually at the sternum-xiphoid junction using a tape measure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schroth | Experimental | Other: SchrothSchroth experimental group |
| Control | No intervention | –Group of participants without Schroth method intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of idiopathic scoliosis; Age range of 10-18 years (adolescent); Cobb angle greater than 10; No other types of exercise, medical treatment.
Key exclusion criteria (1 listed)
- The existence of some contraindications for exercise, psychological problems, neuro-logical-muscular diseases; Previous spine surgery.
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 |
|---|---|---|
| SchrothPatients in the experimental group exercised for 90 minutes a day, three days a week. Schroth exercises were performed in an asymmetrical position to improve the symmetry of the trunk. These exercises include stretching, flexion, spinal lengthening, derotation, strengthening, and rotational breathing exercises. The respondents combined these exercises with everyday life activities. In the control group, subjects were taught Schroth exercises under the supervision of an authorized physiotherapist, and they were asked to practice the exercises as regularly as possible at home. | Other | Schroth |
Primary outcome
The Cobb angle
Time frame: 8 weeks
The Coob angle expressed in degrees, was obtained using a standard anterior-posterior standing radiograph of the complete spine .
Angle of trunk rotation
Time frame: 8 weeks
The angle of trunk rotation (ATR) was measured with a Bunnell scoliometer, in a forward bending standing position. The scoliometer was placed on the patient's back cen-trally over the spine. ATR is expressed in degrees.
Vital Capacity (VC)
Time frame: 8 weeks
Vital Capacity (VC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.
Forced Vital Capacity (FVC)
Time frame: 8 weeks
Forced Vital Capacity (FVC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy) and present maximum amount of air a person can forcibly exhale after taking a deep breath The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values in liters.
Forced Expiratory Volume in One Second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in One Second (FEV1) is the amount of air a person can forcibly exhale in the first second of a forced breath after taking a deep inhalation. Measuring using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.
Chest expansion
Time frame: 8 weeks
Chest expansion was measured manually using a tape marked in millimeters. Chest expansion was measured at the junction between the xiphoid process and the body of the sternum and expressed in centimeters.
5 secondary outcomes
Date of birth
Time frame: 8 weeks
Height
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Gender
Time frame: 8 weeks
Body Mass Index (BMI)
Time frame: 8 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 19 Mar 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in scoliosis. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
Dragan Marinkovic, Msc principal investigator
University of Novi Sad, Faculty of Sport and Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schroth in people with Idiopathic Scoliosis, run by University of Novi Sad at 1 site in Serbia.
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 1 inclusion and 1 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 19 Mar 2025. 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 Serbia. 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?
The Cobb angle (time frame: 8 weeks). The study lists 6 primary outcomes in all. 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 19 Mar 2025.