Adolescent Idiopathic ScoliosisNCT06023992
Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life?
An observational study of Adolescent Idiopathic Scoliosis, run by Halic University.
Trial summary
Idiopathic scoliosis is a spinal deformity that occurs in adolescent girls and boys and is more progressive in girls. The cosmetic changes caused by the scoliotic spine cause negativity in perception of appearance and psychosocial problems in pubertal individuals, especially in girls. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 15 Jun 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 12 to 17 years
- Women only
- Child
Study population: A clinic where individuals with scoliosis are treated and followed up by specialist physician and physiotherapists, as well as a scoliosis brace production and application center: Formed Healthcare Orthotics and Prosthesis Center - Scoliosis Unit.
Who may be able to join
- Provided that the family and the child volunteer to participate in the study,
- Being diagnosed with idiopathic scoliosis
- Girl gender,
- Be 12 years or older,
- Using and still wearing braces for at least 3 months due to AIS,
- Having been prescribed an exercise program
Who cannot join
- Having had previous spine surgery,
- Presence of a psychological or psychiatric diagnosis,
- Presence of any neurological, muscular, rheumatic or orthopedic diseases accompanying scoliosis.
About this study
Idiopathic scoliosis is a spinal deformity that occurs in adolescent girls and boys and is more progressive in girls. The cosmetic changes caused by the scoliotic spine cause negativity in perception of appearance and psychosocial problems in pubertal individuals, especially in girls. It is thought that brace used in conservative treatment increase this negativity in body image and affect compliance with treatment. In this study, it was aimed to determine whether there is an effect on the individual's compliance with the programmed treatment by investigating the perception of body appearance, self-esteem and quality of life of adolescent girls with idiopathic scoliosis. In this context, forty adolescent girls diagnosed with "idiopathic scoliosis" and followed in the "Formed Healthcare Scoliosis Unit" were included in the study. In the study, Walter Reed Visual Evaluation Scale was used to evaluate perception of appearance, Coopersmith Self-Esteem Inventory to evaluate self-esteem, and SRS-22 Scoliosis Patient Questionnaire to evaluate quality of life. Scoliosis Treatment Compliance Scale, which was developed by us and whose validity and reliability study was planned, was used to evaluate compliance with the treatment program.
Read the detailed description
Scoliosis is a three-dimensional deformity of the spine in which a lateral deviation of more than 10º is observed in the coronal plane. Causes deterioration in sagittal, frontal and transverse planes; In scoliosis with lateral flexion, rotation and shortness components, there is a complex curvature of the spine.
The risk of progression, the initial degree of curvature, the age and maturation level of the patient are important for the treatment plan of a patient with AIS. In addition, cosmetic appearance and social factors play a role in the treatment protocol. Methods used in the treatment of scoliosis by considering the progression factor; observation, physiotherapy and specific rehabilitation, brace and surgical treatment.
There are studies showing that the results are positively affected if the programmed and recommended conservative treatment methods are complied with, and the importance of compliance to treatment is emphasized.
In order for the spinal tissues to respond to the forces created by the trunk orthoses (braces) used in the conservative treatment of AIS, a sufficient time and regular use of the brace is required. Studies have shown that there is non-compliance in the treatment process and that patients do not comply with the treatment, especially by not using their braces for a sufficient time during the day.
Exercise therapy has been used for years during follow-up and as a form of conservative therapy. Posture exercises (stabilization exercises) to provide spinal control, exercises to increase spinal flexibility (stretching exercises), exercises to correct muscle strength imbalance and to regulate breathing are applied. It has been reported that compliance with exercise therapy positively affects the treatment results.
It is very important to keep the treatment programs at home, to raise the awareness of the person to control the spine in daily life, to integrate the applied exercises into daily life activities and to support the scoliosis with sports activities. It is reported that correctly planned daily life activities and positions and sports activities that do not involve the risk of injury affect the treatment results positively.
The long treatment period in scoliosis, especially the use of braces, negatively affects daily life and increases the stress level. In this process, individuals with AIS may experience social isolation, depression, low participation in activities and non-compliance. It is mentioned that in order to achieve real success in treatment, the patient should come to terms with the situation he is in cognitively and psychosocial problems should be taken into account.
With the deviations in the frontal, sagittal and transverse planes of the scoliotic spine, the cosmetic effect becomes evident and negatively affects body image perception and psychological health. General physical changes in adolescence are accompanied by a reassessment of the young individual's self-concept. Studies have shown that compliance to treatment in individuals with AIS is associated with body image perceptions and self-esteem.
In addition, scoliosis is an important risk factor for poor quality of life in children and adolescents. It has been reported that the quality of life in AIS is significantly affected by the negative perception of the individual on body image, and low quality of life is associated with low self-esteem, especially in adolescent individuals who use braces.
When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the measurement methods used in studies questioning adherence to treatment in the literature are examined, it is seen that there are limitations in the evaluation of corset and exercise therapy, as well as other treatment components such as daily life and sports activities. Since subjective and objective measurement methods are insufficient to question the treatment as a whole, a scale designed within the scope of this study was also presented to the literature. The aim of the investigators is to solve these limitations in the literature and to determine the effect of perception of deformity, self-esteem and quality of life on the adherence to treatment of the adolescent individual.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, perception of appearance, self-esteem, quality of life, compliance
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Walter Reed Visual Assessment (WRVAS)
It is a valid scale consisting of 7 questions, each of which includes 5 visuals and evaluates the physical deformity perceived by the patients.The selected images are scored as the lowest "1" and the highest "5", and the highest total score is 35 and the lowest is 5. It is accepted that the higher the score, the more negative-evil perception of the deformity.
Measured: Baseline
Coopersmith Self-Esteem Inventory
A valid and reliable short form of 25 questions adapted to children in the same age group was used to determine the level of self-esteem. Those who say 'No' to a negative statement and 'Yes' to a positive statement in the inventory get 1 point for each question. The level of self-esteem obtained is determined as "low" or "high" based on the average score of the group in which the person belongs.
Measured: Baseline
Scoliosis Research Society-22
It is a scoliosis-specific, valid and reliable quality of life scale that questions pain, body image perception, function/activity, mental health, and satisfaction with treatment. A minimum of 1 point (worst) and a maximum of 5 points (best) are taken for each question. Scoring is obtained by dividing the total score from each section by the number of questions in that section. As a result of the scoring, it is accepted that the higher the score, the higher the quality of life.
Measured: Baseline
Scoliosis Treatment Compliance Scale
It is a scale prepared by us to evaluate compliance with the treatment program and recommended Activities of Daily Living in individuals with scoliosis. The patient can get a total of 28 points, with a minimum of 1 and a maximum of 4 points from each statement in the scale. It is observed that the higher the score, the higher the treatment compliance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 Feb 2016
- Primary completion5 Jun 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem Çetinkaya, Halic University
- Investigators
- İrem Çetinkaya, MSc, Principal investigator, Haliç UniversityHürriyet G Yılmaz, MD, Study chair, Haliç UniversityMelek G Yavuzer, MD, Study director, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023992
- Sponsor's protocol ID
- karanki3
- Status last verified
- Sep 2023
- First submitted
- 22 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pineda S, Bago J, Gilperez C, Climent JM. Validity of the Walter Reed Visual Assessment Scale to measure subjective perception of spine deformity in patients with idiopathic scoliosis. Scoliosis. 2006 Nov 8;1:18. doi: 10.1186/1748-7161-1-18.
PubMed 17090338Asher M, Min Lai S, Burton D, Manna B. Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size. Spine (Phila Pa 1976). 2003 Jan 1;28(1):74-8. doi: 10.1097/00007632-200301010-00017.
PubMed 12544960Chan SL, Cheung KM, Luk KD, Wong KW, Wong MS. A correlation study between in-brace correction, compliance to spinal orthosis and health-related quality of life of patients with Adolescent Idiopathic Scoliosis. Scoliosis. 2014 Feb 22;9(1):1. doi: 10.1186/1748-7161-9-1.
PubMed 24559234Donzelli S, Zaina F, Negrini S. Compliance monitor for scoliosis braces in clinical practice. J Child Orthop. 2015 Dec;9(6):507-8. doi: 10.1007/s11832-015-0703-7. Epub 2015 Nov 2. No abstract available.
PubMed 26526180Helfenstein A, Lankes M, Ohlert K, Varoga D, Hahne HJ, Ulrich HW, Hassenpflug J. The objective determination of compliance in treatment of adolescent idiopathic scoliosis with spinal orthoses. Spine (Phila Pa 1976). 2006 Feb 1;31(3):339-44. doi: 10.1097/01.brs.0000197412.70050.0d.
PubMed 16449908Matamalas A, Bago J, D'Agata E, Pellise F. Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments. Health Qual Life Outcomes. 2014 Jun 3;12:81. doi: 10.1186/1477-7525-12-81.
PubMed 24894714Meyer C, Haumont T, Gauchard GC, Leheup B, Lascombes P, Perrin PP. The practice of physical and sporting activity in teenagers with idiopathic scoliosis is related to the curve type. Scand J Med Sci Sports. 2008 Dec;18(6):751-5. doi: 10.1111/j.1600-0838.2007.00750.x. Epub 2008 Feb 2.
PubMed 18248544Negrini S, Antonini G, Carabalona R, Minozzi S. Physical exercises as a treatment for adolescent idiopathic scoliosis. A systematic review. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):227-35. doi: 10.1080/13638490310001636781.
PubMed 14713590Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3.
PubMed 22264320Rivett L, Stewart A, Potterton J. The effect of compliance to a Rigo System Cheneau brace and a specific exercise programme on idiopathic scoliosis curvature: a comparative study: SOSORT 2014 award winner. Scoliosis. 2014 May 30;9:5. doi: 10.1186/1748-7161-9-5. eCollection 2014.
PubMed 24926318Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Feb;41(4):311-9. doi: 10.1097/BRS.0000000000001210.
PubMed 26555827
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to Treatment in Adolescent Girls With Idiopathic Scoliosis: is it Associated With Perception of Appearance, Self-esteem, and Quality of Life?
- ClinicalTrials.gov ID
- NCT06023992
- Acronym / sponsor ID
- karanki3
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, perception of appearance, self-esteem, quality of life, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 5 Sep 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.
Idiopathic scoliosis is a spinal deformity that occurs in adolescent girls and boys and is more progressive in girls. The cosmetic changes caused by the scoliotic spine cause negativity in perception of appearance and psychosocial problems in pubertal individuals, especially in girls. It is thought that brace used in conservative treatment increase this negativity in body image and affect compliance with treatment. In this study, it was aimed to determine whether there is an effect on the individual's compliance with the programmed treatment by investigating the perception of body appearance, self-esteem and quality of life of adolescent girls with idiopathic scoliosis. In this context, forty adolescent girls diagnosed with "idiopathic scoliosis" and followed in the "Formed Healthcare Scoliosis Unit" were included in the study. In the study, Walter Reed Visual Evaluation Scale was used to evaluate perception of appearance, Coopersmith Self-Esteem Inventory to evaluate self-esteem, and SRS-22 Scoliosis Patient Questionnaire to evaluate quality of life. Scoliosis Treatment Compliance Scale, which was developed by us and whose validity and reliability study was planned, was used to evaluate compliance with the treatment program.
Detailed description
Scoliosis is a three-dimensional deformity of the spine in which a lateral deviation of more than 10º is observed in the coronal plane. Causes deterioration in sagittal, frontal and transverse planes; In scoliosis with lateral flexion, rotation and shortness components, there is a complex curvature of the spine.
The risk of progression, the initial degree of curvature, the age and maturation level of the patient are important for the treatment plan of a patient with AIS. In addition, cosmetic appearance and social factors play a role in the treatment protocol. Methods used in the treatment of scoliosis by considering the progression factor; observation, physiotherapy and specific rehabilitation, brace and surgical treatment.
There are studies showing that the results are positively affected if the programmed and recommended conservative treatment methods are complied with, and the importance of compliance to treatment is emphasized.
In order for the spinal tissues to respond to the forces created by the trunk orthoses (braces) used in the conservative treatment of AIS, a sufficient time and regular use of the brace is required. Studies have shown that there is non-compliance in the treatment process and that patients do not comply with the treatment, especially by not using their braces for a sufficient time during the day.
Exercise therapy has been used for years during follow-up and as a form of conservative therapy. Posture exercises (stabilization exercises) to provide spinal control, exercises to increase spinal flexibility (stretching exercises), exercises to correct muscle strength imbalance and to regulate breathing are applied. It has been reported that compliance with exercise therapy positively affects the treatment results.
It is very important to keep the treatment programs at home, to raise the awareness of the person to control the spine in daily life, to integrate the applied exercises into daily life activities and to support the scoliosis with sports activities. It is reported that correctly planned daily life activities and positions and sports activities that do not involve the risk of injury affect the treatment results positively.
The long treatment period in scoliosis, especially the use of braces, negatively affects daily life and increases the stress level. In this process, individuals with AIS may experience social isolation, depression, low participation in activities and non-compliance. It is mentioned that in order to achieve real success in treatment, the patient should come to terms with the situation he is in cognitively and psychosocial problems should be taken into account.
With the deviations in the frontal, sagittal and transverse planes of the scoliotic spine, the cosmetic effect becomes evident and negatively affects body image perception and psychological health. General physical changes in adolescence are accompanied by a reassessment of the young individual's self-concept. Studies have shown that compliance to treatment in individuals with AIS is associated with body image perceptions and self-esteem.
In addition, scoliosis is an important risk factor for poor quality of life in children and adolescents. It has been reported that the quality of life in AIS is significantly affected by the negative perception of the individual on body image, and low quality of life is associated with low self-esteem, especially in adolescent individuals who use braces.
When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the literature is examined, studies examining the psychosocial effects of individuals with AIS and their relationships with quality of life and compliance to treatment are very limited. When the measurement methods used in studies questioning adherence to treatment in the literature are examined, it is seen that there are limitations in the evaluation of corset and exercise therapy, as well as other treatment components such as daily life and sports activities. Since subjective and objective measurement methods are insufficient to question the treatment as a whole, a scale designed within the scope of this study was also presented to the literature. The aim of the investigators is to solve these limitations in the literature and to determine the effect of perception of deformity, self-esteem and quality of life on the adherence to treatment of the adolescent individual.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Age groups
- Child
- Study population
- A clinic where individuals with scoliosis are treated and followed up by specialist physician and physiotherapists, as well as a scoliosis brace production and application center: Formed Healthcare Orthotics and Prosthesis Center - Scoliosis Unit.
Key inclusion criteria (6 listed)
- Provided that the family and the child volunteer to participate in the study,
- Being diagnosed with idiopathic scoliosis
- Girl gender,
- Be 12 years or older,
- Using and still wearing braces for at least 3 months due to AIS,
Key exclusion criteria (3 listed)
- Having had previous spine surgery,
- Presence of a psychological or psychiatric diagnosis,
- Presence of any neurological, muscular, rheumatic or orthopedic diseases accompanying scoliosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Walter Reed Visual Assessment (WRVAS)
Time frame: Baseline
It is a valid scale consisting of 7 questions, each of which includes 5 visuals and evaluates the physical deformity perceived by the patients.The selected images are scored as the lowest "1" and the highest "5", and the highest total score is 35 and the lowest is 5. It is accepted that the higher the score, the more negative-evil perception of the deformity.
Coopersmith Self-Esteem Inventory
Time frame: Baseline
A valid and reliable short form of 25 questions adapted to children in the same age group was used to determine the level of self-esteem. Those who say 'No' to a negative statement and 'Yes' to a positive statement in the inventory get 1 point for each question. The level of self-esteem obtained is determined as "low" or "high" based on the average score of the group in which the person belongs.
Scoliosis Research Society-22
Time frame: Baseline
It is a scoliosis-specific, valid and reliable quality of life scale that questions pain, body image perception, function/activity, mental health, and satisfaction with treatment. A minimum of 1 point (worst) and a maximum of 5 points (best) are taken for each question. Scoring is obtained by dividing the total score from each section by the number of questions in that section. As a result of the scoring, it is accepted that the higher the score, the higher the quality of life.
Scoliosis Treatment Compliance Scale
Time frame: Baseline
It is a scale prepared by us to evaluate compliance with the treatment program and recommended Activities of Daily Living in individuals with scoliosis. The patient can get a total of 28 points, with a minimum of 1 and a maximum of 4 points from each statement in the scale. It is observed that the higher the score, the higher the treatment compliance.
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 5 Sep 2023.
- Results publication: PubMed 17090338Pineda S, Bago J, Gilperez C, Climent JM. Validity of the Walter Reed Visual Assessment Scale to measure subjective perception of spine deformity in patients with idiopathic scoliosis. Scoliosis. 2006 Nov 8;1:18. doi: 10.1186/1748-7161-1-18.
- Results publication: PubMed 12544960Asher M, Min Lai S, Burton D, Manna B. Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size. Spine (Phila Pa 1976). 2003 Jan 1;28(1):74-8. doi: 10.1097/00007632-200301010-00017.
- Results publication: PubMed 24559234Chan SL, Cheung KM, Luk KD, Wong KW, Wong MS. A correlation study between in-brace correction, compliance to spinal orthosis and health-related quality of life of patients with Adolescent Idiopathic Scoliosis. Scoliosis. 2014 Feb 22;9(1):1. doi: 10.1186/1748-7161-9-1.
- Results publication: PubMed 26526180Donzelli S, Zaina F, Negrini S. Compliance monitor for scoliosis braces in clinical practice. J Child Orthop. 2015 Dec;9(6):507-8. doi: 10.1007/s11832-015-0703-7. Epub 2015 Nov 2. No abstract available.
- Results publication: PubMed 16449908Helfenstein A, Lankes M, Ohlert K, Varoga D, Hahne HJ, Ulrich HW, Hassenpflug J. The objective determination of compliance in treatment of adolescent idiopathic scoliosis with spinal orthoses. Spine (Phila Pa 1976). 2006 Feb 1;31(3):339-44. doi: 10.1097/01.brs.0000197412.70050.0d.
- Results publication: PubMed 24894714Matamalas A, Bago J, D'Agata E, Pellise F. Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments. Health Qual Life Outcomes. 2014 Jun 3;12:81. doi: 10.1186/1477-7525-12-81.
- Results publication: PubMed 18248544Meyer C, Haumont T, Gauchard GC, Leheup B, Lascombes P, Perrin PP. The practice of physical and sporting activity in teenagers with idiopathic scoliosis is related to the curve type. Scand J Med Sci Sports. 2008 Dec;18(6):751-5. doi: 10.1111/j.1600-0838.2007.00750.x. Epub 2008 Feb 2.
- Results publication: PubMed 14713590Negrini S, Antonini G, Carabalona R, Minozzi S. Physical exercises as a treatment for adolescent idiopathic scoliosis. A systematic review. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):227-35. doi: 10.1080/13638490310001636781.
- Results publication: PubMed 22264320Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3.
- Results publication: PubMed 24926318Rivett L, Stewart A, Potterton J. The effect of compliance to a Rigo System Cheneau brace and a specific exercise programme on idiopathic scoliosis curvature: a comparative study: SOSORT 2014 award winner. Scoliosis. 2014 May 30;9:5. doi: 10.1186/1748-7161-9-5. eCollection 2014.
- Results publication: PubMed 26555827Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Feb;41(4):311-9. doi: 10.1097/BRS.0000000000001210.
- 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.
İrem Çetinkaya, MSc principal investigator
Haliç University
Hürriyet G Yılmaz, MD study chair
Haliç University
Melek G Yavuzer, MD study director
Haliç University
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Halic University.
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 6 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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Walter Reed Visual Assessment (WRVAS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023992, which also lists 11 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 5 Sep 2023.