An observational study in Adolescent Idiopathic Scoliosis (AIS), sponsored by Kahramanmaras Sutcu Imam University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Kahramanmaras Sutcu Imam University · Observational
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may be associated with misconceptions regarding its causes, symptoms, progression, and treatment. The Scoliosis Misconception Scale (SMS) was developed to assess patients' understanding and misconceptions about AIS.
This observational methodological study aims to cross-culturally adapt the SMS into Turkish and evaluate its psychometric properties in adolescents with idiopathic scoliosis. A total of 200 patients aged 10-17 years with AIS will be recruited. The Turkish version of the 17-item SMS will be administered, and test-retest reliability will be assessed in a subgroup of 50 participants approximately two weeks after the initial assessment.
The study will examine item-level measurement properties, internal consistency, and test-retest reliability. Item response theory analyses will also be considered, depending on model assumptions and sample adequacy. The findings are expected to provide evidence regarding the suitability of the Turkish SMS for assessing scoliosis-related misconceptions in Turkish-speaking adolescents.
This study is designed as an observational, cross-cultural adaptation and psychometric validation study of the Scoliosis Misconception Scale (SMS) in Turkish-speaking patients with adolescent idiopathic scoliosis (AIS).
The SMS was originally developed to evaluate misconceptions regarding the etiology, symptoms, effects, and treatment of AIS. The original questionnaire consisted of 17 true-false statements and was subsequently refined to a 12-item version following psychometric evaluation. For the present study, the 17-item version provided by the scale developers was translated and culturally adapted into Turkish.
The adaptation process includes forward translation, back-translation, expert review, and pilot testing. Following these procedures, the Turkish SMS will be administered to 200 adolescents aged 10-17 years with a confirmed diagnosis of AIS and a Cobb angle of at least 10 degrees.
Demographic and clinical characteristics, including age, sex, anthropometric measurements, time since diagnosis, Cobb angle, curve location, brace use, physiotherapy history, family history of scoliosis, and previous scoliosis-related education, will be recorded.
A subgroup of 50 participants will complete the questionnaire again after approximately 14 days to assess test-retest reliability.
Psychometric evaluation will include descriptive item analysis, internal consistency, test-retest reliability, and assessment of measurement properties using classical test theory. Item response theory models will also be evaluated when their assumptions and sample requirements are met.
The study aims to establish evidence for the reliability and validity of the Turkish SMS and to support the identification of scoliosis-related misconceptions in adolescents with AIS.
This is a cross-sectional psychometric validation study with a repeated-measures component for assessing test-retest reliability in a subgroup of participants.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 256 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.
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The study population will consist of Turkish-speaking adolescents aged 10-17 years with a confirmed diagnosis of adolescent idiopathic scoliosis and a Cobb angle of at least 10°. Participants will be recruited from a private physiotherapy clinic in Kahramanmaras, Turkey. The study aims to enroll 200 adolescents for the main psychometric evaluation, with a subgroup of 50 participants undergoing a repeated assessment approximately 14 days after baseline to evaluate test-retest reliability. Adolescents with different curve patterns, curve magnitudes, and previous or current brace and physiotherapy experiences will be eligible, provided that they meet the study criteria.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will include 200 adolescents aged 10-17 years with a confirmed diagnosis of adolescent idiopathic scoliosis and a Cobb angle of at least 10 degrees. Participants will complete the Turkish version of the Scoliosis Misconception Scale. A subgroup of 50 participants will complete a second assessment approximately 14 days after the initial administration to evaluate test-retest reliability.
Internal Consistency of the Turkish Scoliosis Misconception Scale
Internal consistency of the Turkish 17-item Scoliosis Misconception Scale will be assessed using the Kuder-Richardson Formula 20 (KR-20) coefficient for dichotomously scored items (0 = correct response, 1 = incorrect response). Higher total scores indicate a greater number of scoliosis-related misconceptions. Item-total correlations will also be examined.
Time frame: Baseline (initial assessment)
Test-Retest Reliability of the Turkish Scoliosis Misconception Scale
Test-retest reliability will be evaluated in a subgroup of 50 participants who will complete the Turkish Scoliosis Misconception Scale twice, approximately 14 days apart. The agreement between total scores obtained at the two assessments will be examined using the intraclass correlation coefficient (ICC) with a 95% confidence interval.
Time frame: Baseline and approximately 14 days after baseline
Item-Level Psychometric Properties of the Turkish Scoliosis Misconception Scale
Item-level psychometric properties of the Turkish 17-item Scoliosis Misconception Scale will be evaluated using the proportion of incorrect responses for each item and corrected item-total correlations. Each item is scored dichotomously (0 = correct response, 1 = incorrect response). Item-level results will be used to examine response distributions and discrimination within the study sample.
Time frame: Baseline (initial assessment)
Item Response Theory Parameters of the Turkish Scoliosis Misconception Scale
Item response theory (IRT) analyses will be conducted to evaluate the measurement properties of the Turkish Scoliosis Misconception Scale. Subject to assessment of model assumptions and parameter estimation adequacy, one-parameter and two-parameter logistic IRT models will be examined. Item difficulty and discrimination parameters, model fit, and test information will be evaluated.
Time frame: Baseline (initial assessment)
Plan to share: No — Individual participant data will not be made publicly available or shared with external researchers due to participant confidentiality and privacy considerations, particularly because the study involves minors. Study findings will be reported in aggregate form without identifying individual participants.
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