Scoliosis IdiopathicNCT07552662
Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises With Idiopathic Scoliosis
A study testing PSSE-Schroth Exercises and General Exercises in people with Scoliosis Idiopathic and Exercise, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period. Primary outcomes include Cobb angle progression and brace prescription rate. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Exercise, Scroth
- What is being tested?
- PSSE-Schroth Exercises and General Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2024to 18 Nov 2025
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of adolescent idiopathic scoliosis
- Cobb angle 10°-25°
- Risser sign 0-3 ATR >5°
- Less than 1 year post-menarche (for females)
Who cannot join
- Previous brace treatment * Non-idiopathic scoliosis
- Previous scoliosis surgery
- Neuromuscular or congenital scoliosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Şahinbey, 27000
About this study
Official title: Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises Versus General Exercises in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period. Primary outcomes include Cobb angle progression and brace prescription rate. Secondary outcomes include trunk rotation, quality of life, self-image, and body symmetry.
Read the detailed description
Adolescent idiopathic scoliosis is a three-dimensional spinal deformity that may progress during growth. Although PSSE is increasingly recommended in conservative scoliosis management, comparative randomized evidence remains limited. This study aims to compare PSSE-Schroth exercises with General Exercises in adolescents with mild idiopathic scoliosis over 12 months. Participants are randomized into intervention or control groups receiving matched exercise dosage and supervision. Outcomes assess radiographic progression, trunk rotation, need for bracing, and patient-reported clinical parameters.
- Conditions
- Scoliosis Idiopathic, Exercise, Scroth
- Being tested
- PSSE-Schroth Exercises, General Exercises
- Keywords
- Scoliosis Idiopathic, Cobb angle, quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSSE-Schroth ExercisesOther
Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training
General ExercisesOther
Participants performed general strengthening and stretching exercises without scoliosis-specific correction.
| Study group | Role | What they receive |
|---|---|---|
| PSSE-Schroth Group | Experimental | Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training. Receives: Other: PSSE-Schroth Exercises |
| General Exercise Group | Active comparator | Participants performed general strengthening and stretching exercises without scoliosis-specific correction. Receives: Other: General Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb Angle
Cobb angle will be measured on standing anteroposterior spinal radiographs using the standard Cobb method. The angle is defined as the intersection of lines drawn parallel to the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the primary curve. Measurements will be performed at baseline and after the intervention period, and the change in Cobb angle (in degrees) will be calculated. Lower values indicate an improvement in spinal curvature.
Measured: Baseline to 12 Months
Brace Prescription Rate
The proportion of participants requiring orthotic bracing during the study period will be recorded. Brace prescription will be determined by a specialist according to established clinical criteria (e.g., curve magnitude, skeletal maturity, and risk of progression). The rate will be expressed as the percentage of participants prescribed a brace in each group during the follow-up period.
Measured: 12 Months
Secondary outcomes (3)
SRS-22 Questionnaire Score
Health-related quality of life will be assessed using the Scoliosis Research Society-22 Questionnaire (SRS-22). This validated instrument includes five domains: function/activity, pain, self-image/appearance, mental health, and satisfaction with management. Each item is scored on a 5-point Likert scale, with higher scores indicating better health status. Assessments will be performed at baseline and after the intervention period, and changes in domain and total scores will be analyzed.
Measured: Baseline to 12 Months
TAPS Score
Trunk appearance will be assessed using the Trunk Appearance Perception Scale (TAPS). This patient-reported outcome measure evaluates subjective perception of trunk deformity using a set of standardized drawings viewed from different perspectives. Each item is scored on a Likert scale, with higher scores indicating better perceived trunk appearance (less deformity). Assessments will be conducted at baseline and after the intervention period, and changes in TAPS scores will be analyzed.
Measured: Baseline to 12 Months
TRACE Score
Clinical trunk deformity will be assessed using the Trunk Aesthetic Clinical Evaluation (TRACE) scale. This clinician-rated tool evaluates visible asymmetries of the shoulders, scapulae, waist, and hemithorax. Each domain is scored based on the severity of asymmetry, and a total score is calculated, with higher scores indicating greater aesthetic deformity. Assessments will be performed at baseline and after the intervention period, and changes in TRACE scores will be analyzed.
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start18 Apr 2024
- Primary completion18 Nov 2024
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies 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 were randomized in a 1:1 ratio to either PSSE-Schroth or General Exercise intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Yakut, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552662
- Sponsor's protocol ID
- 825/2
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Chai T, Weng H, Liu Y. Pelvic rotation correction combined with Schroth exercises for pelvic and spinal deformities in mild adolescent idiopathic scoliosis: A randomized controlled trial. PLoS One. 2024 Jul 30;19(7):e0307955. doi: 10.1371/journal.pone.0307955. eCollection 2024.
PubMed 39078854Mohamed N, Acharya V, Schreiber S, Parent EC, Westover L. Effect of adding Schroth physiotherapeutic scoliosis specific exercises to standard care in adolescents with idiopathic scoliosis on posture assessed using surface topography: A secondary analysis of a Randomized Controlled Trial (RCT). PLoS One. 2024 Apr 30;19(4):e0302577. doi: 10.1371/journal.pone.0302577. eCollection 2024.
PubMed 38687741Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.
PubMed 25780260Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
PubMed 24047455Bago J, Sanchez-Raya J, Perez-Grueso FJ, Climent JM. The Trunk Appearance Perception Scale (TAPS): a new tool to evaluate subjective impression of trunk deformity in patients with idiopathic scoliosis. Scoliosis. 2010 Mar 25;5:6. doi: 10.1186/1748-7161-5-6.
PubMed 20338048Asher M, Min Lai S, Burton D, Manna B. The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis. Spine (Phila Pa 1976). 2003 Jan 1;28(1):63-9. doi: 10.1097/00007632-200301010-00015.
PubMed 12544958Langensiepen S, Semler O, Sobottke R, Fricke O, Franklin J, Schonau E, Eysel P. Measuring procedures to determine the Cobb angle in idiopathic scoliosis: a systematic review. Eur Spine J. 2013 Nov;22(11):2360-71. doi: 10.1007/s00586-013-2693-9. Epub 2013 Feb 27.
PubMed 23443679
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises Versus General Exercises in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07552662
- Acronym / sponsor ID
- 825/2
- Conditions
- Scoliosis Idiopathic, Exercise, Scroth
- Keywords
- Scoliosis Idiopathic, Cobb angle, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 27 Apr 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 randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period. Primary outcomes include Cobb angle progression and brace prescription rate. Secondary outcomes include trunk rotation, quality of life, self-image, and body symmetry.
Detailed description
Adolescent idiopathic scoliosis is a three-dimensional spinal deformity that may progress during growth. Although PSSE is increasingly recommended in conservative scoliosis management, comparative randomized evidence remains limited. This study aims to compare PSSE-Schroth exercises with General Exercises in adolescents with mild idiopathic scoliosis over 12 months. Participants are randomized into intervention or control groups receiving matched exercise dosage and supervision. Outcomes assess radiographic progression, trunk rotation, need for bracing, and patient-reported clinical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either PSSE-Schroth or General Exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| PSSE-Schroth Group | Experimental | Other: PSSE-Schroth ExercisesParticipants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training. |
| General Exercise Group | Active comparator | Other: General ExercisesParticipants performed general strengthening and stretching exercises without scoliosis-specific correction. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of adolescent idiopathic scoliosis
Key exclusion criteria (3 listed)
- Previous brace treatment * Non-idiopathic scoliosis
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 |
|---|---|---|
| PSSE-Schroth ExercisesParticipants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training | Other | PSSE-Schroth Group |
| General ExercisesParticipants performed general strengthening and stretching exercises without scoliosis-specific correction. | Other | General Exercise Group |
Primary outcome
Change in Cobb Angle
Time frame: Baseline to 12 Months
Cobb angle will be measured on standing anteroposterior spinal radiographs using the standard Cobb method. The angle is defined as the intersection of lines drawn parallel to the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the primary curve. Measurements will be performed at baseline and after the intervention period, and the change in Cobb angle (in degrees) will be calculated. Lower values indicate an improvement in spinal curvature.
Brace Prescription Rate
Time frame: 12 Months
The proportion of participants requiring orthotic bracing during the study period will be recorded. Brace prescription will be determined by a specialist according to established clinical criteria (e.g., curve magnitude, skeletal maturity, and risk of progression). The rate will be expressed as the percentage of participants prescribed a brace in each group during the follow-up period.
3 secondary outcomes
SRS-22 Questionnaire Score
Time frame: Baseline to 12 Months
TAPS Score
Time frame: Baseline to 12 Months
TRACE Score
Time frame: Baseline to 12 Months
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 27 Apr 2026.
- Results publication: PubMed 39078854Zhang Y, Chai T, Weng H, Liu Y. Pelvic rotation correction combined with Schroth exercises for pelvic and spinal deformities in mild adolescent idiopathic scoliosis: A randomized controlled trial. PLoS One. 2024 Jul 30;19(7):e0307955. doi: 10.1371/journal.pone.0307955. eCollection 2024.
- Results publication: PubMed 38687741Mohamed N, Acharya V, Schreiber S, Parent EC, Westover L. Effect of adding Schroth physiotherapeutic scoliosis specific exercises to standard care in adolescents with idiopathic scoliosis on posture assessed using surface topography: A secondary analysis of a Randomized Controlled Trial (RCT). PLoS One. 2024 Apr 30;19(4):e0302577. doi: 10.1371/journal.pone.0302577. eCollection 2024.
- Results publication: PubMed 25780260Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.
- Results publication: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Results publication: PubMed 24047455Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
- Results publication: PubMed 20338048Bago J, Sanchez-Raya J, Perez-Grueso FJ, Climent JM. The Trunk Appearance Perception Scale (TAPS): a new tool to evaluate subjective impression of trunk deformity in patients with idiopathic scoliosis. Scoliosis. 2010 Mar 25;5:6. doi: 10.1186/1748-7161-5-6.
- Results publication: PubMed 12544958Asher M, Min Lai S, Burton D, Manna B. The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis. Spine (Phila Pa 1976). 2003 Jan 1;28(1):63-9. doi: 10.1097/00007632-200301010-00015.
- Results publication: PubMed 23443679Langensiepen S, Semler O, Sobottke R, Fricke O, Franklin J, Schonau E, Eysel P. Measuring procedures to determine the Cobb angle in idiopathic scoliosis: a systematic review. Eur Spine J. 2013 Nov;22(11):2360-71. doi: 10.1007/s00586-013-2693-9. Epub 2013 Feb 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSSE-Schroth Exercises and General Exercises in people with Scoliosis Idiopathic and Exercise, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 27 Apr 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 Turkey (Türkiye). 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 (time frame: Baseline to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07552662, which also lists 8 linked publications.
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 27 Apr 2026.