Adolescent Idiopathic Scoliosis (AIS)SMS-TRNCT07909174
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Adolescents aged 10-17 years.
- Confirmed diagnosis of adolescent idiopathic scoliosis (AIS).
- Radiographically confirmed spinal curvature with a Cobb angle of at least 10°.
- Ability to understand and respond to the Turkish version of the questionnaire.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the adolescent.
Who cannot join
- Non-idiopathic scoliosis, including congenital, neuromuscular, or syndromic scoliosis.
- Previous spinal surgery for scoliosis.
- Cognitive or communication impairments that prevent reliable questionnaire completion.
- Inability to complete the questionnaire independently or with the standardized assistance permitted by the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mehmet Emin Sigindim Private Physiotherapy Practice
Kahramanmaraş, Kahramanmaraş, 46100
Mehmet Emin Sigindim, PT, +90 507 021 73 42, fzt.mehmeteminsigindim@gmail.com
Esra Nur Türkmen, PhD, PT
About this study
Official title: Cross-Cultural Adaptation and Psychometric Validation of the Turkish Scoliosis Misconception Scale in Patients With Adolescent Idiopathic Scoliosis
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.
Read the detailed description
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.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis Misconception Scale, Turkish Validation, Cross-Cultural Adaptation, Psychometric Validation, Adolescent Idiopathic Scoliosis, Item Response Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents With Idiopathic Scoliosis | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and approximately 14 days after baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (initial assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start21 Oct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Turkmen, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909174
- Sponsor's protocol ID
- KSU-SMS-2026-398
- Acronym
- SMS-TR
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Cheung AKP, Lau CCY, Chan MCM, Kwan KYH. Development and validation of the scoliosis misconception scale (SMS) for assessing level of misconception of patients with adolescent idiopathic scoliosis. Eur Spine J. 2021 Dec;30(12):3517-3524. doi: 10.1007/s00586-021-06943-9. Epub 2021 Aug 2.
PubMed 34341882
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Validation of the Turkish Scoliosis Misconception Scale in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07909174
- Acronym / sponsor ID
- SMS-TR / KSU-SMS-2026-398
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis Misconception Scale, Turkish Validation, Cross-Cultural Adaptation, Psychometric Validation, Adolescent Idiopathic Scoliosis, Item Response Theory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents With Idiopathic Scoliosis | – | –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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- Adolescents aged 10-17 years.
- Confirmed diagnosis of adolescent idiopathic scoliosis (AIS).
- Radiographically confirmed spinal curvature with a Cobb angle of at least 10°.
- Ability to understand and respond to the Turkish version of the questionnaire.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the adolescent.
Key exclusion criteria (4 listed)
- Non-idiopathic scoliosis, including congenital, neuromuscular, or syndromic scoliosis.
- Previous spinal surgery for scoliosis.
- Cognitive or communication impairments that prevent reliable questionnaire completion.
- Inability to complete the questionnaire independently or with the standardized assistance permitted by the study protocol.
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
Internal Consistency of the Turkish Scoliosis Misconception Scale
Time frame: Baseline (initial assessment)
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.
Test-Retest Reliability of the Turkish Scoliosis Misconception Scale
Time frame: Baseline and approximately 14 days after baseline
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.
2 secondary outcomes
Item-Level Psychometric Properties of the Turkish Scoliosis Misconception Scale
Time frame: Baseline (initial assessment)
Item Response Theory Parameters of the Turkish Scoliosis Misconception Scale
Time frame: Baseline (initial assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 34341882Cheung AKP, Lau CCY, Chan MCM, Kwan KYH. Development and validation of the scoliosis misconception scale (SMS) for assessing level of misconception of patients with adolescent idiopathic scoliosis. Eur Spine J. 2021 Dec;30(12):3517-3524. doi: 10.1007/s00586-021-06943-9. Epub 2021 Aug 2.
- Individual participant dataSharing planned: 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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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.
Mehmet Emin Sigindim Private Physiotherapy Practice
Kahramanmaraş, Turkey (Türkiye)
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 Adolescent Idiopathic Scoliosis (AIS), run by Kahramanmaras Sutcu Imam 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 5 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency of the Turkish Scoliosis Misconception Scale (time frame: Baseline (initial assessment)). 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 NCT07909174, which also lists 1 linked publication.
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 2 Nov 2026.