ScoliosisNCT04873986
Scoliosis Tele-Screening Test
An observational study of Scoliosis and Posture Disorders in Children, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
A new Scoliosis Tele-Screening Test (STS-Test) was developed by a study group of the "Scoliosis Research and Treatment Association Turkey". It will be sent to the families of schoolchildren by e-mail in Turkey. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Scoliosis, Posture Disorders in Children
- What is being tested?
- Scoliosis Tele-Screening Test
- How many people
- 865 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2020to May 2021
- 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 9 to 16 years
- All sexes
- Child
Study population: Schoolchildren age between 9-16 in Turkey.
Who may be able to join
- healthy children who agree to voluntarily participate in the study by parents and theirself
- parents must be literate and have the ability to use the internet
Who cannot join
- neurological disease
- spine surgery history
- any disease that prevents standing position
- any cognitive impairment or communication problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Halic University
Istanbul, Beyoğlu/İstanbul, 34445
About this study
Official title: A New Clinical Tool for Scoliosis Risk Analysis: Scoliosis Tele-Screening Test
A new Scoliosis Tele-Screening Test (STS-Test) was developed by a study group of the "Scoliosis Research and Treatment Association Turkey". It will be sent to the families of schoolchildren by e-mail in Turkey. Participants with moderate and high risk for scoliosis according to the result of this test will be invited to the physical examination by the scoliosis specialists, if it is not possible, they will be evaluated via tele-medicine. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible.
The aim of this study is to evaluate the validity and reliability of this novel scoliosis tele-screening test. A secondary aim is to investigate the coherence of this new test between scoliosis physician and parent when applied to the same child. Specificity, sensitivity, negative predictive value, positive predictive value, and test accuracy will be calculated for the Scoliosis Tele-Screening Test. Correlation between STS-Test and Trace, Adams' test, and physician diagnosis will be analyzed.
Read the detailed description
Scoliosis is a three-dimensional spinal and trunk deformity. Adolescent Idiopathic Scoliosis prevalence is 3,1% in females and 1,5% in males in Turkey. Most of the cases are asymptomatic, therefore screening programs are very crucial for early diagnosis especially for cases in risky ages. Early diagnosis provides the early treatment.
Aesthetic evaluation of the trunk is one of the important components of Idiopathic Scoliosis and aesthetic appearance which is the main complaint of the patients and family is the primary aim of the conservative and operative treatment. There are some tools that evaluates postural asymmetries like Trunk Aesthetic Clinical Evaluation which evaluates the shoulder, scapula, waist, and hemithorax and known as a reliable instrument for everyday clinical evaluation and to monitor aesthetic changes achieved with treatment.
A scoliosis screening test has been developed in which families with restricted access to the hospital and healthcare professionals due to the Covid-19 pandemic, can evaluate their children in terms of scoliosis risk without applying to any health institution. A study group of subject experts was formed within the "Scoliosis Research and Treatment Association Turkey". This new tele-screening test could be easily applied by parents at a home in different times, give information about the results to the implementer just after the evaluation. Researchers discussed how to evaluate the spine for scoliosis in a virtual environment and were created a visual screening test. In the scoring of the STS-Test, the images related to the body asymmetry of patients with scoliosis with different deformities characteristics in the common database of these experts were analyzed and scoring was created by expert opinion and consensus.
Scoliosis risk was determined by considering the visual body asymmetries in the shoulder, thorax, waist, and pelvis, in addition, Adams' test. For the girls, female gender and time since menarche as a risk factor were included in the total score. In STS-Test scoring, the positive Adams' test is 4 points for both genders; the presence of family history related to scoliosis is 1 point; female gender was as 1 point; no menarche, or time less than 1-year since menarche for girls, was determined as 1 point. In the scoring of the other items, the anterior shoulder levels and height difference in the pelvis were scored as 2 points; if there was asymmetry in the images of the items including shoulder level difference from the posterior, scapula asymmetry, pelvic shifting to one side and height difference in the pelvis, they were scored as 1 point, and if symmetrical or not able to make a decision, it was scored as 0 points. Scoliosis Tele-Screening Test consists of a total of 23 Likert-type questions; 5 questions about the sociodemographic characteristics of the parents, 3 questions on the knowledge/awareness level regarding scoliosis, 3 questions on the risk factors related to scoliosis development, 7 questions about the cosmetic deformities that scoliosis may cause/can reveal, and 5 questions the satisfaction of the parent/evaluator. The total score for risk groups is based on 7 questions about the cosmetic deformities caused by scoliosis and 3 questions regarding the risk factors associated with scoliosis development. The total score is obtained by summing up the scores from 10 questions of these two sections. The total score is categorized as low, medium, and high risk, and the risk groups differ for males and females. 0-4 points are low, 5-11 points are medium, and 12-15 points are considered a high-risk group for girls in the total score. 0-3 points are low, 4-8 points are medium, and 9-13 points are considered high risk group for males in the total score.
The final version of the test was shared on the website of the Scoliosis Research and Treatment Association Turkey and social networks. After the parent/evaluator completed the test, an e-mail containing information about the test, scoliosis risk score, and recommendations was sent with an automatic reply. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible. The patients who could apply to the center will be examined by the physician, evaluated cosmetically according to TRACE, and Adams' test will be performed. Suspicion of scoliosis will be confirmed by spine radiography. Patients with a Cobb angle ≥10° in any segment of the spine will be considered to have scoliosis. The location, direction, and angle of scoliosis will be recorded from the spine radiographs.
- Conditions
- Scoliosis, Posture Disorders in Children
- Being tested
- Scoliosis Tele-Screening Test
- Keywords
- Scoliosis screening, Tele-medicine, virtual assessment, posture
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis Tele-Screening TestDiagnostic test
Scoliosis Tele-Screening test will be applied to children by parents at home. Participants with moderate and high risks will be invited to the physical examination to the centers or virtual assessment via e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Scoliosis Tele-Screening Test
Test Accuracy will be obtained using the formula below Test Accuracy/Power = ((TP+TN) / (TP+TN+FP+FN)) * 100 (TP: True positive, TN: True negative, FN:False negative, FP: False positive) Referral criteria for the accuracy of STS-Test based on Adams' test additionally clinician examination
Measured: through study completion, an average of 1 year
To investigate the consistency between researchers' assessment and the results of the Scoliosis Tele-Screening Test by the parents for the same case
The agreement between the risk analyzes obtained with the STS-Test performed by the parents and the face-to-face spine assessment by a doctor will be determined. Pearson correlation coefficient will be used to investigate the correlations between parents(via the STS-Test score) and physician assessment. Correlation between parameters will be interpreted as follows: r=0-0.19 a very weak correlation, r=0.20-0.39 weak correlation, r=0.40-0.59 moderate correlation, r=0.60-0.79 strong correlation and r=0.80-1 very strong correlation.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Trunk Aesthetic Clinical Evaluation score
Trunk Aesthetic Clinical Evaluation (TRACE) is a clinical tool developed for the evaluation of trunk asymmetries of patients with scoliosis by physicians or therapists. TRACE is a scale that evaluates asymmetry in shoulders, scapula, waist and hemithorax in 4 items and gives a global score that can reflect the clinical change over time. It is scored between 0-2 points for shoulder asymmetry, hemithorax asymmetry, scapula asymmetry, and 0-4 points for waist asymmetry. The total score is obtained by adding 1 point to the total scores of the 4 items, and scoring varies between 1 and 12 points. High scores are associated with increased body asymmetry.
Measured: Baseline
Adams' Forward Bending Test
Adams' Forward Bending Test (FBT) is a clinical test that is frequently performed to reveal the suspicion of scoliosis in scoliosis screening. FBT shows the rib hump deformity caused by the vertebrae and ribs affected by scoliosis when the patient is in the forward bending position. It will recorded as positive or negative
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 May 2021
- Study start23 Nov 2020
- Primary completion25 Jan 2021
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FİLİZ TUNA, Trakya University
- Investigators
- Hurriyet Yilmaz, Prof, Study director, Haliç UniversityFİLİZ TUNA, Assoc Prof, Principal investigator, Trakya UniversityAslıhan Kuşvuran Özkan, MD, Principal investigator, Özel Özülkü Medical CenterSibel Özdoğan, MD, Principal investigator, Yıldız Medstar HospitalZeynep Turan, MD, Principal investigator, Koç UniversityAhsen Büyükaslan, PT, MSc, Principal investigator, Formed Scoliosis Brace and Treatment CenterHande Tunç, PT, MSc, Principal investigator, Formed Scoliosis Brace and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873986
- Sponsor's protocol ID
- TÜTF-BAEK 2020/287
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was not planned to share individual participant data
Publications
Prowse A, Pope R, Gerdhem P, Abbott A. Reliability and validity of inexpensive and easily administered anthropometric clinical evaluation methods of postural asymmetry measurement in adolescent idiopathic scoliosis: a systematic review. Eur Spine J. 2016 Feb;25(2):450-66. doi: 10.1007/s00586-015-3961-7. Epub 2015 Apr 28.
PubMed 25917824Zaina F, Negrini S, Atanasio S. TRACE (Trunk Aesthetic Clinical Evaluation), a routine clinical tool to evaluate aesthetics in scoliosis patients: development from the Aesthetic Index (AI) and repeatability. Scoliosis. 2009 Jan 20;4:3. doi: 10.1186/1748-7161-4-3.
PubMed 19154604Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Yilmaz H, Zateri C, Kusvuran Ozkan A, Kayalar G, Berk H. Prevalence of adolescent idiopathic scoliosis in Turkey: an epidemiological study. Spine J. 2020 Jun;20(6):947-955. doi: 10.1016/j.spinee.2020.01.008. Epub 2020 Jan 20.
PubMed 31972303Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. doi: 10.1186/1748-7161-1-4.
PubMed 16759352Donaldson S, Stephens D, Howard A, Alman B, Narayanan U, Wright JG. Surgical decision making in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Jun 15;32(14):1526-32. doi: 10.1097/BRS.0b013e318067dc75.
PubMed 17572623Negrini S, Donzelli S, Di Felice F, Zaina F, Caronni A. Construct validity of the Trunk Aesthetic Clinical Evaluation (TRACE) in young people with idiopathic scoliosis. Ann Phys Rehabil Med. 2020 May;63(3):216-221. doi: 10.1016/j.rehab.2019.10.008. Epub 2019 Dec 6.
PubMed 31816447
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Clinical Tool for Scoliosis Risk Analysis: Scoliosis Tele-Screening Test
- ClinicalTrials.gov ID
- NCT04873986
- Acronym / sponsor ID
- TÜTF-BAEK 2020/287
- Conditions
- Scoliosis, Posture Disorders in Children
- Keywords
- Scoliosis screening, Tele-medicine, virtual assessment, posture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 5 May 2021 (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.
A new Scoliosis Tele-Screening Test (STS-Test) was developed by a study group of the "Scoliosis Research and Treatment Association Turkey". It will be sent to the families of schoolchildren by e-mail in Turkey. Participants with moderate and high risk for scoliosis according to the result of this test will be invited to the physical examination by the scoliosis specialists, if it is not possible, they will be evaluated via tele-medicine. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible.
The aim of this study is to evaluate the validity and reliability of this novel scoliosis tele-screening test. A secondary aim is to investigate the coherence of this new test between scoliosis physician and parent when applied to the same child. Specificity, sensitivity, negative predictive value, positive predictive value, and test accuracy will be calculated for the Scoliosis Tele-Screening Test. Correlation between STS-Test and Trace, Adams' test, and physician diagnosis will be analyzed.
Detailed description
Scoliosis is a three-dimensional spinal and trunk deformity. Adolescent Idiopathic Scoliosis prevalence is 3,1% in females and 1,5% in males in Turkey. Most of the cases are asymptomatic, therefore screening programs are very crucial for early diagnosis especially for cases in risky ages. Early diagnosis provides the early treatment.
Aesthetic evaluation of the trunk is one of the important components of Idiopathic Scoliosis and aesthetic appearance which is the main complaint of the patients and family is the primary aim of the conservative and operative treatment. There are some tools that evaluates postural asymmetries like Trunk Aesthetic Clinical Evaluation which evaluates the shoulder, scapula, waist, and hemithorax and known as a reliable instrument for everyday clinical evaluation and to monitor aesthetic changes achieved with treatment.
A scoliosis screening test has been developed in which families with restricted access to the hospital and healthcare professionals due to the Covid-19 pandemic, can evaluate their children in terms of scoliosis risk without applying to any health institution. A study group of subject experts was formed within the "Scoliosis Research and Treatment Association Turkey". This new tele-screening test could be easily applied by parents at a home in different times, give information about the results to the implementer just after the evaluation. Researchers discussed how to evaluate the spine for scoliosis in a virtual environment and were created a visual screening test. In the scoring of the STS-Test, the images related to the body asymmetry of patients with scoliosis with different deformities characteristics in the common database of these experts were analyzed and scoring was created by expert opinion and consensus.
Scoliosis risk was determined by considering the visual body asymmetries in the shoulder, thorax, waist, and pelvis, in addition, Adams' test. For the girls, female gender and time since menarche as a risk factor were included in the total score. In STS-Test scoring, the positive Adams' test is 4 points for both genders; the presence of family history related to scoliosis is 1 point; female gender was as 1 point; no menarche, or time less than 1-year since menarche for girls, was determined as 1 point. In the scoring of the other items, the anterior shoulder levels and height difference in the pelvis were scored as 2 points; if there was asymmetry in the images of the items including shoulder level difference from the posterior, scapula asymmetry, pelvic shifting to one side and height difference in the pelvis, they were scored as 1 point, and if symmetrical or not able to make a decision, it was scored as 0 points. Scoliosis Tele-Screening Test consists of a total of 23 Likert-type questions; 5 questions about the sociodemographic characteristics of the parents, 3 questions on the knowledge/awareness level regarding scoliosis, 3 questions on the risk factors related to scoliosis development, 7 questions about the cosmetic deformities that scoliosis may cause/can reveal, and 5 questions the satisfaction of the parent/evaluator. The total score for risk groups is based on 7 questions about the cosmetic deformities caused by scoliosis and 3 questions regarding the risk factors associated with scoliosis development. The total score is obtained by summing up the scores from 10 questions of these two sections. The total score is categorized as low, medium, and high risk, and the risk groups differ for males and females. 0-4 points are low, 5-11 points are medium, and 12-15 points are considered a high-risk group for girls in the total score. 0-3 points are low, 4-8 points are medium, and 9-13 points are considered high risk group for males in the total score.
The final version of the test was shared on the website of the Scoliosis Research and Treatment Association Turkey and social networks. After the parent/evaluator completed the test, an e-mail containing information about the test, scoliosis risk score, and recommendations was sent with an automatic reply. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible. The patients who could apply to the center will be examined by the physician, evaluated cosmetically according to TRACE, and Adams' test will be performed. Suspicion of scoliosis will be confirmed by spine radiography. Patients with a Cobb angle ≥10° in any segment of the spine will be considered to have scoliosis. The location, direction, and angle of scoliosis will be recorded from the spine radiographs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Schoolchildren age between 9-16 in Turkey.
Key inclusion criteria (2 listed)
- healthy children who agree to voluntarily participate in the study by parents and theirself
- parents must be literate and have the ability to use the internet
Key exclusion criteria (4 listed)
- neurological disease
- spine surgery history
- any disease that prevents standing position
- any cognitive impairment or communication problem
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 |
|---|---|---|
| Scoliosis Tele-Screening TestScoliosis Tele-Screening test will be applied to children by parents at home. Participants with moderate and high risks will be invited to the physical examination to the centers or virtual assessment via e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. | Diagnostic test | – |
Primary outcome
Accuracy of Scoliosis Tele-Screening Test
Time frame: through study completion, an average of 1 year
Test Accuracy will be obtained using the formula below Test Accuracy/Power = ((TP+TN) / (TP+TN+FP+FN)) * 100 (TP: True positive, TN: True negative, FN:False negative, FP: False positive) Referral criteria for the accuracy of STS-Test based on Adams' test additionally clinician examination
To investigate the consistency between researchers' assessment and the results of the Scoliosis Tele-Screening Test by the parents for the same case
Time frame: through study completion, an average of 1 year
The agreement between the risk analyzes obtained with the STS-Test performed by the parents and the face-to-face spine assessment by a doctor will be determined. Pearson correlation coefficient will be used to investigate the correlations between parents(via the STS-Test score) and physician assessment. Correlation between parameters will be interpreted as follows: r=0-0.19 a very weak correlation, r=0.20-0.39 weak correlation, r=0.40-0.59 moderate correlation, r=0.60-0.79 strong correlation and r=0.80-1 very strong correlation.
2 secondary outcomes
Trunk Aesthetic Clinical Evaluation score
Time frame: Baseline
Adams' Forward Bending Test
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 25917824Prowse A, Pope R, Gerdhem P, Abbott A. Reliability and validity of inexpensive and easily administered anthropometric clinical evaluation methods of postural asymmetry measurement in adolescent idiopathic scoliosis: a systematic review. Eur Spine J. 2016 Feb;25(2):450-66. doi: 10.1007/s00586-015-3961-7. Epub 2015 Apr 28.
- Background: PubMed 19154604Zaina F, Negrini S, Atanasio S. TRACE (Trunk Aesthetic Clinical Evaluation), a routine clinical tool to evaluate aesthetics in scoliosis patients: development from the Aesthetic Index (AI) and repeatability. Scoliosis. 2009 Jan 20;4:3. doi: 10.1186/1748-7161-4-3.
- Background: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Background: PubMed 31972303Yilmaz H, Zateri C, Kusvuran Ozkan A, Kayalar G, Berk H. Prevalence of adolescent idiopathic scoliosis in Turkey: an epidemiological study. Spine J. 2020 Jun;20(6):947-955. doi: 10.1016/j.spinee.2020.01.008. Epub 2020 Jan 20.
- Background: PubMed 16759352Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. doi: 10.1186/1748-7161-1-4.
- Background: PubMed 17572623Donaldson S, Stephens D, Howard A, Alman B, Narayanan U, Wright JG. Surgical decision making in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Jun 15;32(14):1526-32. doi: 10.1097/BRS.0b013e318067dc75.
- Background: PubMed 31816447Negrini S, Donzelli S, Di Felice F, Zaina F, Caronni A. Construct validity of the Trunk Aesthetic Clinical Evaluation (TRACE) in young people with idiopathic scoliosis. Ann Phys Rehabil Med. 2020 May;63(3):216-221. doi: 10.1016/j.rehab.2019.10.008. Epub 2019 Dec 6.
- Individual participant dataSharing planned: No. It was not planned to share individual participant data
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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.
Hurriyet Yilmaz, Prof study director
Haliç University
FİLİZ TUNA, Assoc Prof principal investigator
Trakya University
Aslıhan Kuşvuran Özkan, MD principal investigator
Özel Özülkü Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Posture Disorders in Children, run by Trakya 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 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: status not confirmed, as of the sponsor's last update on 5 May 2021. 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?
Results are not available in the source record.
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?
Accuracy of Scoliosis Tele-Screening Test (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873986, which also lists 7 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 May 2021.