Adolescent Idiopathic ScoliosisNCT05985902
The Efficiency of Different Exercise Methods in Adolescent Idiopathic Scoliosis
A study testing Core Stabilization Exercises and Schroth Exercises in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic… Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Core Stabilization Exercises and Schroth Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2023to 30 Nov 2024
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with AIS scoliosis
- Individuals agreeing to participate in the study
- Patients between the ages of 10-20
- Patients with AIS whose Cobb angle measured on X-ray is between 15-40 degrees
Who cannot join
- Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
- Patients previously undertaken any of spinal surgeries.
- Patients involved in exercise training 3 or more days a week
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Eyüp, 34050
About this study
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.
Read more
There are no studies in the literature examining the effects of Schroth exercise training on trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and quality of life in children with adolescent idiopathic scoliosis.
The aim of our study is to examine whether Schroth exercise training has an effect on trunk muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis. It is thought that this study will fill the gap in the literature with the original information it will bring to the literature and will shed light on future studies.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Core Stabilization Exercises, Schroth Exercises
- Keywords
- Adolescent Idiopathic scoliosis, Schroth Exercises, Scoliosis Specific Exercises, Trunk Muscle Strength, Respiratory Muscle Strength, Muscle Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesOther
Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus ma
Schroth ExercisesOther
In the Schroth exercise training, there are 3-dimensional exercises that include the principles of axial reach, deflection, derotation, rotational breathing and stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Core stabilization exercise training will be given to the control group for 12 weeks, 7 days a week, for 60 minutes. Core stabilization exercises will be applied to this group under the supervision of a physiotherapist for 2 days in our unit, while home-based core stabilization exercise training will be given on other days of the week. Receives: Other: Core Stabilization Exercises |
| Training Group | Experimental | After the first evaluation, the training group will be given Schroth exercise training for 12 weeks, 7 days a week, for 60 minutes. This group will be given Schroth exercises under the supervision of a physiotherapist for 2 days in our unit, while home-based Schroth exercise training will be given on other days of the week. Receives: Other: Schroth Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Muscle Strength
In order to examine the muscle strength of the patients and the effectiveness of the treatment, the muscle strength of the individuals will be evaluated with the Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) isokinetic dynamometer device. The Biodex isokinetic dynamometer device adapts at a constant speed, allowing a dynamic test that can give resistance. The adaptiveness of the resistance and the ability to give the same resistance throughout the entire range of motion provide maximum muscle strength. In addition to this situation, the performance of the muscles can be evaluated at different angular velocities. Muscle function and muscle strength can be determined during maximum muscle contraction by using a linear scale with isokinetic dynamometer, which is an objective assessment, and with this method, information about the strength of the upper and lower extremities and trunk muscles can be obtained.
Measured: Baseline and after 12 weeks
Muscle Stiffness
Shear Wave Elastography, also known as dynamic elastography, is a sonoelastography examination that has been developed and rapidly developed in recent years, and it provides additional information about tissue properties by evaluating tissue flexibility that can contribute to the diagnosis. In this technique application, a short-term, high-power acoustic repulsive radiation force is applied to the tissue with ultrasound probes. This force causes small displacements in tissues. These displacements in the horizontal plane are called "shear waves" and the rate of progression of these waves in the tissue can be measured. The shear wave velocity is directly proportional to the hardness of the tissue. The velocity values obtained show the objective elasticity values. Patients' spinal and abdominal muscle stiffness will be evaluated with the Toshiba Aplio 500 (Toshiba Medical Systems Corporation, Japan).
Measured: Baseline and after 12 weeks
Respiratory Muscle Strength
Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK). Pressures will be assessed by measurements of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during a few seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) by mouth.
Measured: Baseline and after 12 weeks
Postural Stability
Postural Stability and balance will be evaluated with the Biodex Balance System®. The Biodex Balance System® is a validated and reliable instrument used to assess postural stability, limits of stability and fall risk. It consists of balance platform, arm supports, screen and printer. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degrees in each direction) according to the test to be applied.
Measured: Baseline and after 12 weeks
Cobb Angle
The Cobb angle records at the first visit of the patients. The Cobb angle is the angle between the lines drawn perpendicular to the endplates first and last vertebrae involved in the curvature.
Measured: Baseline and after 12 weeks
Angle of Trunk Rotation
Measurement will be applied with Bunnell Scoliometer by physiotherapist.
Measured: Baseline and after 12 weeks
Quality of Life (Scoliosis Research Society-22)
Measurement will be applied with Scoliosis Research Society-22 Questionnaire. The scale consists of 22 questions and 5 subgroups of questions. Subgroups; pain, evaluation of general appearance, spinal functions, mental health and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated by summing up under the total score. Scores are calculated by assigning an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer; 1 and the most positive gets 5 points. High scores on the scale indicate an increase in quality of life, and low scores indicate a decrease.
Measured: Baseline and after 12 weeks
Cosmetic Deformity Perception
Measurement will be applied with The Walter Reed Visual Assessment Scale. In the scale, deformity is categorized with 7 different aspects. Each of the 7 items contains a set of 5 figures representing the severity of the deformity. In these sets, there are visuals evaluating spine deformity, rib protrusion, waist protrusion, chest deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The visuals include posterior views of the deformity and assess the patient's sense of how other people see their back. The selected images are scored as the lowest "1" and the highest "5", and the higher the total score obtained, the more negative-worse the perceived deformity is defined.
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start25 Jul 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985902
- Sponsor's protocol ID
- BVUsyildirim03
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2023
- Last updated
- 23 Apr 2026
- Results posted
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Different Exercise Methods in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05985902
- Acronym / sponsor ID
- BVUsyildirim03
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic scoliosis, Schroth Exercises, Scoliosis Specific Exercises, Trunk Muscle Strength, Respiratory Muscle Strength, Muscle Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Aug 2023 (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.
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.
There are no studies in the literature examining the effects of Schroth exercise training on trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and quality of life in children with adolescent idiopathic scoliosis.
The aim of our study is to examine whether Schroth exercise training has an effect on trunk muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis. It is thought that this study will fill the gap in the literature with the original information it will bring to the literature and will shed light on future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Core Stabilization ExercisesCore stabilization exercise training will be given to the control group for 12 weeks, 7 days a week, for 60 minutes. Core stabilization exercises will be applied to this group under the supervision of a physiotherapist for 2 days in our unit, while home-based core stabilization exercise training will be given on other days of the week. |
| Training Group | Experimental | Other: Schroth ExercisesAfter the first evaluation, the training group will be given Schroth exercise training for 12 weeks, 7 days a week, for 60 minutes. This group will be given Schroth exercises under the supervision of a physiotherapist for 2 days in our unit, while home-based Schroth exercise training will be given on other days of the week. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with AIS scoliosis
- Individuals agreeing to participate in the study
- Patients between the ages of 10-20
- Patients with AIS whose Cobb angle measured on X-ray is between 15-40 degrees
Key exclusion criteria (3 listed)
- Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
- Patients previously undertaken any of spinal surgeries.
- Patients involved in exercise training 3 or more days a week
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 |
|---|---|---|
| Core Stabilization ExercisesCore stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus ma | Other | Control Group |
| Schroth ExercisesIn the Schroth exercise training, there are 3-dimensional exercises that include the principles of axial reach, deflection, derotation, rotational breathing and stabilization. | Other | Training Group |
Primary outcome
Isokinetic Muscle Strength
Time frame: Baseline and after 12 weeks
In order to examine the muscle strength of the patients and the effectiveness of the treatment, the muscle strength of the individuals will be evaluated with the Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) isokinetic dynamometer device. The Biodex isokinetic dynamometer device adapts at a constant speed, allowing a dynamic test that can give resistance. The adaptiveness of the resistance and the ability to give the same resistance throughout the entire range of motion provide maximum muscle strength. In addition to this situation, the performance of the muscles can be evaluated at different angular velocities. Muscle function and muscle strength can be determined during maximum muscle contraction by using a linear scale with isokinetic dynamometer, which is an objective assessment, and with this method, information about the strength of the upper and lower extremities and trunk muscles can be obtained.
Muscle Stiffness
Time frame: Baseline and after 12 weeks
Shear Wave Elastography, also known as dynamic elastography, is a sonoelastography examination that has been developed and rapidly developed in recent years, and it provides additional information about tissue properties by evaluating tissue flexibility that can contribute to the diagnosis. In this technique application, a short-term, high-power acoustic repulsive radiation force is applied to the tissue with ultrasound probes. This force causes small displacements in tissues. These displacements in the horizontal plane are called "shear waves" and the rate of progression of these waves in the tissue can be measured. The shear wave velocity is directly proportional to the hardness of the tissue. The velocity values obtained show the objective elasticity values. Patients' spinal and abdominal muscle stiffness will be evaluated with the Toshiba Aplio 500 (Toshiba Medical Systems Corporation, Japan).
Respiratory Muscle Strength
Time frame: Baseline and after 12 weeks
Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK). Pressures will be assessed by measurements of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during a few seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) by mouth.
Postural Stability
Time frame: Baseline and after 12 weeks
Postural Stability and balance will be evaluated with the Biodex Balance System®. The Biodex Balance System® is a validated and reliable instrument used to assess postural stability, limits of stability and fall risk. It consists of balance platform, arm supports, screen and printer. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degrees in each direction) according to the test to be applied.
Cobb Angle
Time frame: Baseline and after 12 weeks
The Cobb angle records at the first visit of the patients. The Cobb angle is the angle between the lines drawn perpendicular to the endplates first and last vertebrae involved in the curvature.
Angle of Trunk Rotation
Time frame: Baseline and after 12 weeks
Measurement will be applied with Bunnell Scoliometer by physiotherapist.
Quality of Life (Scoliosis Research Society-22)
Time frame: Baseline and after 12 weeks
Measurement will be applied with Scoliosis Research Society-22 Questionnaire. The scale consists of 22 questions and 5 subgroups of questions. Subgroups; pain, evaluation of general appearance, spinal functions, mental health and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated by summing up under the total score. Scores are calculated by assigning an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer; 1 and the most positive gets 5 points. High scores on the scale indicate an increase in quality of life, and low scores indicate a decrease.
Cosmetic Deformity Perception
Time frame: Baseline and after 12 weeks
Measurement will be applied with The Walter Reed Visual Assessment Scale. In the scale, deformity is categorized with 7 different aspects. Each of the 7 items contains a set of 5 figures representing the severity of the deformity. In these sets, there are visuals evaluating spine deformity, rib protrusion, waist protrusion, chest deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The visuals include posterior views of the deformity and assess the patient's sense of how other people see their back. The selected images are scored as the lowest "1" and the highest "5", and the higher the total score obtained, the more negative-worse the perceived deformity is defined.
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 23 Apr 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.
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 Core Stabilization Exercises and Schroth Exercises in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif 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 23 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?
Isokinetic Muscle Strength (time frame: Baseline and after 12 weeks). The study lists 8 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 23 Apr 2026.