Adolescent Idiopathic ScoliosisNCT04421157
Exercises in Adolescent Idiopathic Scoliosis
A study testing Schroth Exercises and Core stabilization Exercises in people with Adolescent Idiopathic Scoliosis, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate the effectiveness of two different exercises in adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Schroth Exercises and Core stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Oct 2019to 3 Mar 2020
- 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
- Having a diagnosis of adolescent idiopathic scoliosis,
- A Cobb angle of 10 to 30 degrees
- Having Lenke type 1 curve
- No other treatment which might affect scoliosis
Who cannot join
- Non-idiopathic scoliosis
- Prescribed brace
- Surgical correction history
- Who were unable to participate in the supervised sessions,or those who refused to follow treatment were excluded.
- Contraindications to exercise -Accompanying mental problems, neurological- muscular or rheumatic diseases,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karamanoglu Mehmetbey University
Karaman, 70200
About this study
Official title: The Effectiveness of Two Different Exercises in Adolescent Idiopathic Scoliosis: A Single-blind Study
The purpose of this study was to investigate the effectiveness of two different exercises in adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The Schroth group received Schroth exercises in addition to traditional rehabilitation, and the stabilization group received core stabilization in addition to traditional rehabilitation for 10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal mobility, cosmetic trunk deformity, muscle strength, and quality of life.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology, characterized by a three-dimensional deformity of the spine (frontal translation, sagittal modification, and torsion of the spinous processes on the concave side of the scoliotic curve on radiographs).
In patients with AIS, in addition to curve progression there are many problems commonly occur such as; muscular imbalance, functional limitations, altered posture, gait deviations, reduced flexibility of the spine, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected related to the shape and angle of scoliosis, and the weight distribution position changes depending on the shape and the Cobb angle of scoliosis. To deal with these complications and more, various treatment approaches have been proposed for AIS, including exercise, bracing, casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt the progression of the deformity. Conservative treatment methods including physiotherapy and bracing are accepted in Central Europe.
In literature, exercises are recommended to decrease progression, to improve spine and thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including postural training, stretching, and strengthening exercises for spinal musculature, respiratory exercises have been used for many years for scoliosis. Except for the traditional exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim of Schroth exercises is to improve motor control of the posture by repeating corrective movements with progressively less feedback. Schroth exercises are the most studied scoliosis exercises but there are limited randomized controlled studies on Schroth exercises.
Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises, Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises are described as therapy techniques that improve postural control, and functional stability through increasing neuromuscular control, the strength of trunk stabilization muscles, the endurance of postural muscles around the spine, the balance between pelvis and spine. However, limited studies are determining CS exercises' effect on patients with AIS. In a study CS exercises found to be more effective in reducing pain and rotational deformity than traditional exercises in the conservative rehabilitation of AIS.
A recent systematic review showed that therapeutic exercise had been effective to reduce symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to improve muscular endurance, pulmonary function, and functional capacity of patients with AIS. Corrective, therapeutic exercises appear to have positive effects by improving function and reducing symptoms, as well as various angles and body asymmetries. However, further studies with better methodological quality are required to confirm these outcomes and detect the best therapeutic exercise intervention. And also there is a need for randomized controlled studies on different methods of exercise to choose the most effective exercise in clinical practice.
There was no research compared to the effects of the Schroth method and CS exercises in patients with AIS. And also there was no research examining the effects of the Schroth method on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation, peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality of life in patients with AIS.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Schroth Exercises, Core stabilization Exercises
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis, Exercise
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth ExercisesOther
Also called Schroth Method, Scoliosis specific exercises
The Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
Core stabilization ExercisesOther
Each exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Schroth group | Experimental | The Schroth group received Schroth exercises in addition to traditional rehabilitation. Receives: Other: Schroth Exercises |
| Stabilization group | Experimental | The stabilization group received core stabilization in addition to traditional rehabilitation. Receives: Other: Core stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb's angle
Cobb's angles were measured on standard standing anterior-posterior spine radiograph and recorded as degrees. Cobb angle is considered the gold standard to evaluate the curve magnitude. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
Measured: 10 week
Secondary outcomes (5)
Trunk rotation angles
-Trunk rotation angles Axial trunk rotations (ATR) were assessed with a scoliometer in Adam's forward bend test.
Measured: 10 week
Muscle strength
Muscle strengths were assessed by a Biodex System 4-Pro dynamometer (Biodex, Inc., Shirley, New York). Upper extremity pattern strengths (flexion-abduction-external rotation / extension-adduction-internal rotation), and quadriceps, hamstring muscles strengths were assessed in both extremity. The outcome parameter was the peak torque (expressed in Nm) which was normalized to the participants' body weight (expressed in Nm/kg) in an effort to reduce inter-subject variability in raw scores of quantitative muscle tests.
Measured: 10 week
Spinal mobility
Spinal mobility was assessed with a new computer-aided skin-surface device (The Spinal Mouse® System, Idiag, Fehraltorf, Switzerland). Spinal Mouse is an external non-invasive measurement method developed to evaluate the motility and shape of the spine in many planes. The Spinal Mouse has acceptable metrological properties to assess segmental and global thoracal and lumbar mobility. Measurements were performed between spinous process of C7 and the top of the anal crease (approximately S3). Maximal extension, maximal flexion and maximal left and right lateral flexion positions were performed. The analysis of spinal mobility in the sagittal (SAP - maximal extension to flexion) and the coronal (CRP - maximal left to right flexion) plane was evaluated.
Measured: 10 week
Cosmetic trunk deformity
Walter Reed Visual Assessment Scale (WRVAS) was used to assess cosmetic deformity. The domains of WRVAS are body curve, rib prominence, flank prominence, head rib pelvis, head pelvis, shoulder level, and scapular rotation. Each domain generates a score from 1 (best deformity) to 5 (worst deformity). The total score is an average of these 7 domains.
Measured: 10 week
SRS-22 Questionnaire
The SRS-22 questionnaire assesses the quality of life in scoliosis. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions which are scored from 1 (best answer) to 5 (worst answer) each question. A total score is based on all 22 questions and an average of these 7 domains.
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start17 Oct 2019
- Primary completion28 Jan 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Adolescent 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
- Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Kocaman, Karamanoğlu Mehmetbey University
- Investigators
- Hikmet Kocaman, MSc, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421157
- Sponsor's protocol ID
- KaramanogluMehmetbeyU
- Status last verified
- Nov 2020
- First submitted
- 12 May 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romano M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine (Phila Pa 1976). 2013 Jun 15;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.
PubMed 23558442Shneerson JM, Madgwick R. The effect of physical training on exercise ability in adolescent idiopathic scoliosis. Acta Orthop Scand. 1979 Jun;50(3):303-6. doi: 10.3109/17453677908989771.
PubMed 474101Negrini S, Fusco C, Minozzi S, Atanasio S, Zaina F, Romano M. Exercises reduce the progression rate of adolescent idiopathic scoliosis: results of a comprehensive systematic review of the literature. Disabil Rehabil. 2008;30(10):772-85. doi: 10.1080/09638280801889568.
PubMed 18432435Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
PubMed 28033399Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.
PubMed 31286903Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE; ACTIvATeS Study Group. Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis. Physiotherapy. 2019 Jun;105(2):214-234. doi: 10.1016/j.physio.2018.10.004. Epub 2018 Oct 27.
PubMed 30824243Ceballos Laita L, Tejedor Cubillo C, Mingo Gomez T, Jimenez Del Barrio S. Effects of corrective, therapeutic exercise techniques on adolescent idiopathic scoliosis. A systematic review. Arch Argent Pediatr. 2018 Aug 1;116(4):e582-e589. doi: 10.5546/aap.2018.eng.e582. English, Spanish.
PubMed 30016036Kim G, HwangBo PN. Effects of Schroth and Pilates exercises on the Cobb angle and weight distribution of patients with scoliosis. J Phys Ther Sci. 2016 Mar;28(3):1012-5. doi: 10.1589/jpts.28.1012. Epub 2016 Mar 31.
PubMed 27134403Nault ML, Allard P, Hinse S, Le Blanc R, Caron O, Labelle H, Sadeghi H. Relations between standing stability and body posture parameters in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1911-7. doi: 10.1097/00007632-200209010-00018.
PubMed 12221357Sanders JO, Polly DW Jr, Cats-Baril W, Jones J, Lenke LG, O'Brien MF, Stephens Richards B, Sucato DJ; AIS Section of the Spinal Deformity Study Group. Analysis of patient and parent assessment of deformity in idiopathic scoliosis using the Walter Reed Visual Assessment Scale. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2158-63. doi: 10.1097/01.BRS.0000084629.97042.0B.
PubMed 14501929Coelho DM, Bonagamba GH, Oliveira AS. Scoliometer measurements of patients with idiopathic scoliosis. Braz J Phys Ther. 2013 Mar-Apr;17(2):179-84. doi: 10.1590/S1413-35552012005000081.
PubMed 23778766Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.
PubMed 22464116Martinez-Llorens J, Ramirez M, Colomina MJ, Bago J, Molina A, Caceres E, Gea J. Muscle dysfunction and exercise limitation in adolescent idiopathic scoliosis. Eur Respir J. 2010 Aug;36(2):393-400. doi: 10.1183/09031936.00025509. Epub 2009 Dec 23.
PubMed 20032022Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.
PubMed 27625122Ameer MA, Kamel MI, Elhafez YM. A comparison of sagittal spine deformities among elementary school students using spinal mouse device. Work. 2019;64(3):545-550. doi: 10.3233/WOR-193015.
PubMed 31658087
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Two Different Exercises in Adolescent Idiopathic Scoliosis: A Single-blind Study
- ClinicalTrials.gov ID
- NCT04421157
- Acronym / sponsor ID
- KaramanogluMehmetbeyU
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 9 Jun 2020 (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 purpose of this study was to investigate the effectiveness of two different exercises in adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The Schroth group received Schroth exercises in addition to traditional rehabilitation, and the stabilization group received core stabilization in addition to traditional rehabilitation for 10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal mobility, cosmetic trunk deformity, muscle strength, and quality of life.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology, characterized by a three-dimensional deformity of the spine (frontal translation, sagittal modification, and torsion of the spinous processes on the concave side of the scoliotic curve on radiographs).
In patients with AIS, in addition to curve progression there are many problems commonly occur such as; muscular imbalance, functional limitations, altered posture, gait deviations, reduced flexibility of the spine, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected related to the shape and angle of scoliosis, and the weight distribution position changes depending on the shape and the Cobb angle of scoliosis. To deal with these complications and more, various treatment approaches have been proposed for AIS, including exercise, bracing, casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt the progression of the deformity. Conservative treatment methods including physiotherapy and bracing are accepted in Central Europe.
In literature, exercises are recommended to decrease progression, to improve spine and thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including postural training, stretching, and strengthening exercises for spinal musculature, respiratory exercises have been used for many years for scoliosis. Except for the traditional exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim of Schroth exercises is to improve motor control of the posture by repeating corrective movements with progressively less feedback. Schroth exercises are the most studied scoliosis exercises but there are limited randomized controlled studies on Schroth exercises.
Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises, Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises are described as therapy techniques that improve postural control, and functional stability through increasing neuromuscular control, the strength of trunk stabilization muscles, the endurance of postural muscles around the spine, the balance between pelvis and spine. However, limited studies are determining CS exercises' effect on patients with AIS. In a study CS exercises found to be more effective in reducing pain and rotational deformity than traditional exercises in the conservative rehabilitation of AIS.
A recent systematic review showed that therapeutic exercise had been effective to reduce symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to improve muscular endurance, pulmonary function, and functional capacity of patients with AIS. Corrective, therapeutic exercises appear to have positive effects by improving function and reducing symptoms, as well as various angles and body asymmetries. However, further studies with better methodological quality are required to confirm these outcomes and detect the best therapeutic exercise intervention. And also there is a need for randomized controlled studies on different methods of exercise to choose the most effective exercise in clinical practice.
There was no research compared to the effects of the Schroth method and CS exercises in patients with AIS. And also there was no research examining the effects of the Schroth method on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation, peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality of life in patients with AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)
| Arm | Type | Receives |
|---|---|---|
| Schroth group | Experimental | Other: Schroth ExercisesThe Schroth group received Schroth exercises in addition to traditional rehabilitation. |
| Stabilization group | Experimental | Other: Core stabilization ExercisesThe stabilization group received core stabilization in addition to traditional rehabilitation. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Having a diagnosis of adolescent idiopathic scoliosis,
- A Cobb angle of 10 to 30 degrees
- Having Lenke type 1 curve
- No other treatment which might affect scoliosis
Key exclusion criteria (5 listed)
- Non-idiopathic scoliosis
- Prescribed brace
- Surgical correction history
- Who were unable to participate in the supervised sessions,or those who refused to follow treatment were excluded.
- Contraindications to exercise -Accompanying mental problems, neurological- muscular or rheumatic diseases,
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 |
|---|---|---|
| Schroth ExercisesAlso: Schroth Method, Scoliosis specific exercisesThe Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period. | Other | Schroth group |
| Core stabilization ExercisesEach exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period. | Other | Stabilization group |
Primary outcome
Cobb's angle
Time frame: 10 week
Cobb's angles were measured on standard standing anterior-posterior spine radiograph and recorded as degrees. Cobb angle is considered the gold standard to evaluate the curve magnitude. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
5 secondary outcomes
Trunk rotation angles
Time frame: 10 week
Muscle strength
Time frame: 10 week
Spinal mobility
Time frame: 10 week
Cosmetic trunk deformity
Time frame: 10 week
SRS-22 Questionnaire
Time frame: 10 week
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 30 Nov 2020.
- Background: PubMed 23558442Romano M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine (Phila Pa 1976). 2013 Jun 15;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.
- Background: PubMed 474101Shneerson JM, Madgwick R. The effect of physical training on exercise ability in adolescent idiopathic scoliosis. Acta Orthop Scand. 1979 Jun;50(3):303-6. doi: 10.3109/17453677908989771.
- Background: PubMed 18432435Negrini S, Fusco C, Minozzi S, Atanasio S, Zaina F, Romano M. Exercises reduce the progression rate of adolescent idiopathic scoliosis: results of a comprehensive systematic review of the literature. Disabil Rehabil. 2008;30(10):772-85. doi: 10.1080/09638280801889568.
- Background: PubMed 28033399Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
- Background: PubMed 31286903Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.
- Background: PubMed 30824243Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE; ACTIvATeS Study Group. Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis. Physiotherapy. 2019 Jun;105(2):214-234. doi: 10.1016/j.physio.2018.10.004. Epub 2018 Oct 27.
- Background: PubMed 30016036Ceballos Laita L, Tejedor Cubillo C, Mingo Gomez T, Jimenez Del Barrio S. Effects of corrective, therapeutic exercise techniques on adolescent idiopathic scoliosis. A systematic review. Arch Argent Pediatr. 2018 Aug 1;116(4):e582-e589. doi: 10.5546/aap.2018.eng.e582. English, Spanish.
- Background: PubMed 27134403Kim G, HwangBo PN. Effects of Schroth and Pilates exercises on the Cobb angle and weight distribution of patients with scoliosis. J Phys Ther Sci. 2016 Mar;28(3):1012-5. doi: 10.1589/jpts.28.1012. Epub 2016 Mar 31.
- Background: PubMed 12221357Nault ML, Allard P, Hinse S, Le Blanc R, Caron O, Labelle H, Sadeghi H. Relations between standing stability and body posture parameters in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1911-7. doi: 10.1097/00007632-200209010-00018.
- Background: PubMed 14501929Sanders JO, Polly DW Jr, Cats-Baril W, Jones J, Lenke LG, O'Brien MF, Stephens Richards B, Sucato DJ; AIS Section of the Spinal Deformity Study Group. Analysis of patient and parent assessment of deformity in idiopathic scoliosis using the Walter Reed Visual Assessment Scale. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2158-63. doi: 10.1097/01.BRS.0000084629.97042.0B.
- Background: PubMed 23778766Coelho DM, Bonagamba GH, Oliveira AS. Scoliometer measurements of patients with idiopathic scoliosis. Braz J Phys Ther. 2013 Mar-Apr;17(2):179-84. doi: 10.1590/S1413-35552012005000081.
- Background: PubMed 22464116Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.
- Individual participant dataSharing planned: No
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Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Hikmet Kocaman, MSc principal investigator
Karamanoğlu Mehmetbey University
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 Exercises and Core stabilization Exercises in people with Adolescent Idiopathic Scoliosis, run by Karamanoğlu Mehmetbey 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 5 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 30 Nov 2020. 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?
Cobb's angle (time frame: 10 week). 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 NCT04421157, which also lists 20 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 30 Nov 2020.