Adolescent Idiopathic ScoliosisNCT02552615
Effectiveness of Exercises in Adolescent Idiopathic Scoliosis
A study testing body awareness therapy, core stabilization exercises and traditional exercises in people with Adolescent Idiopathic Scoliosis, run by Gözde Gür at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of spinal stabilization and body awareness in addition to brace wearing versus classical exercises on subjective verticality perception, trunk symmetry and quality of life in AIS. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- body awareness therapy, core stabilization exercises and traditional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jun 2015
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who were diagnosed with idiopathic scoliosis
- ages between 10 and 16 who were prescribed a brace
Who cannot join
- Patients who did not accept to participate in the study or wear a spinal brace
- congenital curve
- neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases, tumors,
- previous surgical correction or conservative therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: Investigation of the Effects of Spinal Stabilization and Body Awareness Exercises on Subjective Vertical Perception, Curve Magnitude, Body Symmetry and Quality of Life in Adolescent Idiopathic Scoliosis
The aim of this study was to compare the effects of spinal stabilization and body awareness in addition to brace wearing versus classical exercises on subjective verticality perception, trunk symmetry and quality of life in AIS. Study included 30 AIS patients between the ages of 14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and 13.60±1.65 (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and haptic (SHV) and deformity perception, quality of life were assessed at baseline and after 10th week of treatment. Cobb angle decreased in stabilization and awareness groups. Rotation decreased in three groups. SVV improved in all groups. SPV and SHV, body asymmetry and cosmetic deformity improved in stabilization and awareness groups. Only function improved with stabilization treatment. Stabilization and body awareness exercises created positive changes in AIS.
Read the detailed description
In patients with idiopathic scoliosis (IS), in addition to curve progression there are many problems including altered posture, gait deviations, muscular imbalance, functional limitations, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms commonly occur. To cope with these complications and more, conservative treatment of adolescent idiopathic scoliosis (AIS) involves a variety of bracing methods and exercises.
Spinal bracing is an important treatment option to prevent curve progression in moderate curves (between 20-40) and severe curves in AIS. Bracing success rate is reported 80% in the long term but the level of evidence is still low.
In literature, exercises are recommended to reduce progression, to improve spine and thoracic cage flexibility, muscle elasticity and strength, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including stretching, strengthening exercises for spinal musculature, postural training, respiratory exercises have been used for many years for IS. Besides traditional exercises, there are several exercise concepts including SEAS, Schroth, Dobomed, Side Shift methods... etc. Effectiveness of exercise is still in debate and there is need for further studies, which investigate the role of specific exercises for scoliosis in conservative treatment.
In scoliosis, muscle imbalances, the deficiency of muscle ability to stabilize posture, the loss in balance of pelvis-spine relation due to lateral tilt of the body and postural control impairment resulting from these problems are defined. In addition, the tree dimensional scoliotic deformity cause sensory disturbances, standing instability and gait modifications. Core stabilization exercises (CSE) are described as therapy technique that improve neuromuscular control, strength of trunk stabilization muscles, endurance of postural muscles, trunk mobilization muscles around spine, balance between pelvis and spine in order to maintain functional stability and postural control.
It was indicated in the literature that patients with AIS exhibit disturbances of vertical perception. Postural vertical line is important for a person to perceive body orientation in space and thereby to provide and maintain upright posture and gait. Body Awareness Therapy (BAT) is a mind-body approach, which aims to improve body awareness, body posture, quality of movements, balance, postural control integrating with slow movement co-ordination and breathing exercises. BAT programs also contain stretching exercises, relaxing exercises and gait training. Patients are instructed to concentrate body vertical line and all movements are thought to initiate from body center. BAT have been studied in many medical conditions including back pain, anxiety, fibromyalgia, eating disorders, heart diseases, falls in elderly.
However, there are limited studies determining CSE effects on patients with scoliosis: one have reported improvement in Cobb's angle and pain and the other in sitting balance with lumbar stabilization exercises. There was no research examining the effects of BAT in scoliosis. However for the reasons mentioned above, we hypothesized that CSE and BAT therapies can have positive effects on postural re-alignment and trunk deformity in patients with AIS. The aim of this study was to investigate the effects of core stabilization and body awareness exercises versus traditional exercises in addition to brace wearing on vertical perception, trunk asymmetry, cosmetic deformity and health related quality of life in patients with AIS.
The aim of this study was to compare the effects of spinal stabilization and body awareness exercises in addition to brace wearing versus traditional exercises on subjective verticality perception, trunk symmetry, cosmetic deformity and health related quality of life in Adolescent idiopathic scoliosis (AIS). This study included 30 AIS patients between the ages of 14,40 ± 2,01 years (stabilization group), 14,2 ± 2 years (Body awareness group) ve 13,60 ± 1,65 (classical group). Following recording demographic data, bone maturation level according to Riser, curve types according to King, spinal region, which includes curve, were recorded. Cobb angles by antero-posterior X-ray, rotation degrees with scoliometer in Adam's forward bend test, subjective visual (SVV), postural (SPV) and haptic (SHV) verticality perception with laser stick system, cosmetic deformity perception for patient, family and physiotherapist according with Walter Reed Visual Assessment Scale (WRVAS), trunk asymmetries with Posterior Trunk Asymmetry Index (POTSI) and health related quality of life with SRS-22 were assessed at baseline and after 10th week of treatment.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- body awareness therapy, core stabilization exercises, traditional exercises
- Keywords
- scoliosis, verticality perception, body symmetry
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body awareness therapyOther
core stabilization exercisesOther
traditional exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| body awareness therapy (BAT) | Experimental | Each session started with short warm-up, continued with specific exercises. Following each session, verbal reflexions was taken for 10 minutes. Exercises fulfilled in lying, sitting, standing and walking positions. Additionally program included vocal-breathing exercises and massage. Patients received 20 sessions for one hour at clinic for ten-week treatment period. Receives: Other: body awareness therapy |
| Traditional exercises | Active comparator | Program included traditional exercises intended for strengthening back, abdominal, pelvis and shoulder girdle muscles and muscles in convex side of the curve, stretching exercises especially for the concave side of the curve, flexibility exercises for spine, postural training and breathing exercises. Patients received 20 sessions for one hour at clinic for ten-week treatment period. Receives: Other: traditional exercises |
| core stabilization exercises | Experimental | Exercises started to progress from static to dynamic positions in which muscle activation incorporate into functional tasks including trunk and extremity movements. Local, global muscle stability training, global muscle mobility training and strengthening training of these core structure was carried out progressively advancing more difficult. Patients received 20 sessions for one hour at clinic for ten-week treatment period. Receives: Other: core stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
cobb 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
Measured: 10 weeks
Secondary outcomes (5)
Posterior Trunk Asymmetry Index (POTSI)
POTSI is a surface topography method, which scores body shape and asymmetry objectively. The measurements of patient's back were taken for the calculation of the score POTSI is composed of six index including frontal asymmetry index (FAI), height differences index (HDI) for shoulder, axilla and trunk regions. Total score is a sum of these six indexes.
Measured: 10 weeks
axial trunk rotation
Axial trunk rotations (ATR) were assessed with scoliometer in Adam's forward bend test
Measured: 10 weeks
Walter Reed Visual Assessment Scale (WRVAS)
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). Total score is an average of these 7 domains
Measured: 10 weeks
SRS-22 Questionnaire
It assess quality of life in scoliosis. This instrument consists of six domains including function, pain, self-image, mental health, satisfaction/dissatisfaction which are scored from 1 (best answer) to 5 (worst answer) each question
Measured: 10 weeks
vertical perception
All visual (SVV), postural (SPV) and haptic (SHV) subjective vertical perception tests were performed using manually controlled laser liner device by the therapist in a darkened, silent and empty room. The therapist put laser line as deviated from vertical, then turned it to vertical slowly and asked patient to find true earth vertical. Subjects were instructed to tell "stop" when they thought it is correct angle for them. Assessment were repeated for horizontal line and at the angles of 30°, 45°, 60° left and 30°, 45°, 60° right (according to the ground). This test expressed SVV assessment. For SPV patient predict angle with his/her hand position. For SHV, patients predict angle by holding a wooden stick with their hands.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJun 2015
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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gözde Gür
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Gözde Gür, Hacettepe University
- Investigators
- Gozde Gur, PhD, Principal investigator, research assistant and physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552615
- Sponsor's protocol ID
- Go 14/19
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 23558442Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.
PubMed 23732766Shneerson 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 474101Weinstein 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 24047455Maruyama T, Grivas TB, Kaspiris A. Effectiveness and outcomes of brace treatment: a systematic review. Physiother Theory Pract. 2011 Jan;27(1):26-42. doi: 10.3109/09593985.2010.503989.
PubMed 21198404Negrini S, Minozzi S, Bettany-Saltikov J, Chockalingam N, Grivas TB, Kotwicki T, Maruyama T, Romano M, Zaina F. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev. 2015 Jun 18;2015(6):CD006850. doi: 10.1002/14651858.CD006850.pub3.
PubMed 26086959Negrini 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 18432435Nault 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 12221357Muthukrishnan R, Shenoy SD, Jaspal SS, Nellikunja S, Fernandes S. The differential effects of core stabilization exercise regime and conventional physiotherapy regime on postural control parameters during perturbation in patients with movement and control impairment chronic low back pain. Sports Med Arthrosc Rehabil Ther Technol. 2010 May 31;2:13. doi: 10.1186/1758-2555-2-13.
PubMed 20515453Cakrt O, Slaby K, Viktorinova L, Kolar P, Jerabek J. Subjective visual vertical in patients with idiopatic scoliosis. J Vestib Res. 2011;21(3):161-5. doi: 10.3233/VES-2011-0414.
PubMed 21558641Alves 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 22464116Gur G, Dilek B, Ayhan C, Simsek E, Aras O, Aksoy S, Yakut Y. Effect of a spinal brace on postural control in different sensory conditions in adolescent idiopathic scoliosis: a preliminary analysis. Gait Posture. 2015 Jan;41(1):93-9. doi: 10.1016/j.gaitpost.2014.09.001. Epub 2014 Sep 16.
PubMed 25262334Coelho 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 23778766Sanders 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 14501929Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.
PubMed 24682356
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Spinal Stabilization and Body Awareness Exercises on Subjective Vertical Perception, Curve Magnitude, Body Symmetry and Quality of Life in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02552615
- Acronym / sponsor ID
- Go 14/19
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- scoliosis, verticality perception, body symmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gözde GürUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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 aim of this study was to compare the effects of spinal stabilization and body awareness in addition to brace wearing versus classical exercises on subjective verticality perception, trunk symmetry and quality of life in AIS. Study included 30 AIS patients between the ages of 14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and 13.60±1.65 (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and haptic (SHV) and deformity perception, quality of life were assessed at baseline and after 10th week of treatment. Cobb angle decreased in stabilization and awareness groups. Rotation decreased in three groups. SVV improved in all groups. SPV and SHV, body asymmetry and cosmetic deformity improved in stabilization and awareness groups. Only function improved with stabilization treatment. Stabilization and body awareness exercises created positive changes in AIS.
Detailed description
In patients with idiopathic scoliosis (IS), in addition to curve progression there are many problems including altered posture, gait deviations, muscular imbalance, functional limitations, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms commonly occur. To cope with these complications and more, conservative treatment of adolescent idiopathic scoliosis (AIS) involves a variety of bracing methods and exercises.
Spinal bracing is an important treatment option to prevent curve progression in moderate curves (between 20-40) and severe curves in AIS. Bracing success rate is reported 80% in the long term but the level of evidence is still low.
In literature, exercises are recommended to reduce progression, to improve spine and thoracic cage flexibility, muscle elasticity and strength, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including stretching, strengthening exercises for spinal musculature, postural training, respiratory exercises have been used for many years for IS. Besides traditional exercises, there are several exercise concepts including SEAS, Schroth, Dobomed, Side Shift methods... etc. Effectiveness of exercise is still in debate and there is need for further studies, which investigate the role of specific exercises for scoliosis in conservative treatment.
In scoliosis, muscle imbalances, the deficiency of muscle ability to stabilize posture, the loss in balance of pelvis-spine relation due to lateral tilt of the body and postural control impairment resulting from these problems are defined. In addition, the tree dimensional scoliotic deformity cause sensory disturbances, standing instability and gait modifications. Core stabilization exercises (CSE) are described as therapy technique that improve neuromuscular control, strength of trunk stabilization muscles, endurance of postural muscles, trunk mobilization muscles around spine, balance between pelvis and spine in order to maintain functional stability and postural control.
It was indicated in the literature that patients with AIS exhibit disturbances of vertical perception. Postural vertical line is important for a person to perceive body orientation in space and thereby to provide and maintain upright posture and gait. Body Awareness Therapy (BAT) is a mind-body approach, which aims to improve body awareness, body posture, quality of movements, balance, postural control integrating with slow movement co-ordination and breathing exercises. BAT programs also contain stretching exercises, relaxing exercises and gait training. Patients are instructed to concentrate body vertical line and all movements are thought to initiate from body center. BAT have been studied in many medical conditions including back pain, anxiety, fibromyalgia, eating disorders, heart diseases, falls in elderly.
However, there are limited studies determining CSE effects on patients with scoliosis: one have reported improvement in Cobb's angle and pain and the other in sitting balance with lumbar stabilization exercises. There was no research examining the effects of BAT in scoliosis. However for the reasons mentioned above, we hypothesized that CSE and BAT therapies can have positive effects on postural re-alignment and trunk deformity in patients with AIS. The aim of this study was to investigate the effects of core stabilization and body awareness exercises versus traditional exercises in addition to brace wearing on vertical perception, trunk asymmetry, cosmetic deformity and health related quality of life in patients with AIS.
The aim of this study was to compare the effects of spinal stabilization and body awareness exercises in addition to brace wearing versus traditional exercises on subjective verticality perception, trunk symmetry, cosmetic deformity and health related quality of life in Adolescent idiopathic scoliosis (AIS). This study included 30 AIS patients between the ages of 14,40 ± 2,01 years (stabilization group), 14,2 ± 2 years (Body awareness group) ve 13,60 ± 1,65 (classical group). Following recording demographic data, bone maturation level according to Riser, curve types according to King, spinal region, which includes curve, were recorded. Cobb angles by antero-posterior X-ray, rotation degrees with scoliometer in Adam's forward bend test, subjective visual (SVV), postural (SPV) and haptic (SHV) verticality perception with laser stick system, cosmetic deformity perception for patient, family and physiotherapist according with Walter Reed Visual Assessment Scale (WRVAS), trunk asymmetries with Posterior Trunk Asymmetry Index (POTSI) and health related quality of life with SRS-22 were assessed at baseline and after 10th week of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| body awareness therapy (BAT) | Experimental | Other: body awareness therapyEach session started with short warm-up, continued with specific exercises. Following each session, verbal reflexions was taken for 10 minutes. Exercises fulfilled in lying, sitting, standing and walking positions. Additionally program included vocal-breathing exercises and massage. Patients received 20 sessions for one hour at clinic for ten-week treatment period. |
| Traditional exercises | Active comparator | Other: traditional exercisesProgram included traditional exercises intended for strengthening back, abdominal, pelvis and shoulder girdle muscles and muscles in convex side of the curve, stretching exercises especially for the concave side of the curve, flexibility exercises for spine, postural training and breathing exercises. Patients received 20 sessions for one hour at clinic for ten-week treatment period. |
| core stabilization exercises | Experimental | Other: core stabilization exercisesExercises started to progress from static to dynamic positions in which muscle activation incorporate into functional tasks including trunk and extremity movements. Local, global muscle stability training, global muscle mobility training and strengthening training of these core structure was carried out progressively advancing more difficult. Patients received 20 sessions for one hour at clinic for ten-week treatment period. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients who were diagnosed with idiopathic scoliosis
- ages between 10 and 16 who were prescribed a brace
Key exclusion criteria (4 listed)
- Patients who did not accept to participate in the study or wear a spinal brace
- congenital curve
- neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases, tumors,
- previous surgical correction or conservative therapy
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 |
|---|---|---|
| body awareness therapy | Other | body awareness therapy (BAT) |
| core stabilization exercises | Other | core stabilization exercises |
| traditional exercises | Other | Traditional exercises |
Primary outcome
cobb angle
Time frame: 10 weeks
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
5 secondary outcomes
Posterior Trunk Asymmetry Index (POTSI)
Time frame: 10 weeks
axial trunk rotation
Time frame: 10 weeks
Walter Reed Visual Assessment Scale (WRVAS)
Time frame: 10 weeks
SRS-22 Questionnaire
Time frame: 10 weeks
vertical perception
Time frame: 10 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 17 Sep 2015.
- 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 23732766Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.
- 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 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.
- Background: PubMed 21198404Maruyama T, Grivas TB, Kaspiris A. Effectiveness and outcomes of brace treatment: a systematic review. Physiother Theory Pract. 2011 Jan;27(1):26-42. doi: 10.3109/09593985.2010.503989.
- Background: PubMed 26086959Negrini S, Minozzi S, Bettany-Saltikov J, Chockalingam N, Grivas TB, Kotwicki T, Maruyama T, Romano M, Zaina F. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev. 2015 Jun 18;2015(6):CD006850. doi: 10.1002/14651858.CD006850.pub3.
- 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 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 20515453Muthukrishnan R, Shenoy SD, Jaspal SS, Nellikunja S, Fernandes S. The differential effects of core stabilization exercise regime and conventional physiotherapy regime on postural control parameters during perturbation in patients with movement and control impairment chronic low back pain. Sports Med Arthrosc Rehabil Ther Technol. 2010 May 31;2:13. doi: 10.1186/1758-2555-2-13.
- Background: PubMed 21558641Cakrt O, Slaby K, Viktorinova L, Kolar P, Jerabek J. Subjective visual vertical in patients with idiopatic scoliosis. J Vestib Res. 2011;21(3):161-5. doi: 10.3233/VES-2011-0414.
- 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.
- Background: PubMed 25262334Gur G, Dilek B, Ayhan C, Simsek E, Aras O, Aksoy S, Yakut Y. Effect of a spinal brace on postural control in different sensory conditions in adolescent idiopathic scoliosis: a preliminary analysis. Gait Posture. 2015 Jan;41(1):93-9. doi: 10.1016/j.gaitpost.2014.09.001. Epub 2014 Sep 16.
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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.
Gozde Gur, PhD principal investigator
research assistant and physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body awareness therapy, core stabilization exercises and traditional exercises in people with Adolescent Idiopathic Scoliosis, run by Gözde Gür 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 2 inclusion and 4 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 17 Sep 2015. 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 angle (time frame: 10 weeks). 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 NCT02552615, 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 17 Sep 2015.