Adolescent Idiopathic ScoliosisNCT04720677
Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS
An observational study of Adolescent Idiopathic Scoliosis and Health Related Quality of Life, run by Hürriyet Yılmaz at 1 site in Turkey (Türkiye).
Trial summary
The ISYQOL questionnaire was translated into Turkish and was assessed the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency, and construct validity in this research. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Health Related Quality of Life
- What is being tested?
- Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2019to 30 Jan 2022
- 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 10 to 18 years
- Women only
- Child, Adult
Study population: Adolescent girls with idiopathic scoliosis
Who may be able to join
- who has diagnosed with AIS
- aged 10 to 18 years
- curvature between 10 ° to 45 ° ,
- native Turkish speaker adolescents who accepted to participate in the study and approved by their parents.
Who cannot join
- non-idiopathic scoliosis
- history of spinal surgery,
- spinal trauma, tumor, infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Formed Healthcare Scoliosis Brace and Treatment Center
Istanbul, 34371
About this study
The ISYQOL questionnaire was translated into Turkish and was assessed the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency, and construct validity in this research.
Read the detailed description
HRQOL is considered one of the most relevant outcomes of both conservative and surgical treatment of scoliosis, for this reason, several questionnaires (e.g. SRS-24 and SRS-22) have been developed. SRS-22 has been reported as the most commonly used scale to measure HRQOL in patient with scoliosis in many countries. However, current literature showed that SRS-22 has poor measurement properties, it does not satisfy fundamental measure requirements, i.e. additivity, generalizability and unidimensionality. According to Rasch analysis study SRS-24 and SRS-22 presents high ceiling effects in conservative care, for the reason that was developed for surgical candidates. The Italian Spine Youth Quality of Life (ISYQOL) questionnaire originally in Italian, is the first HRQOL questionnaire developed according to the Rasch analysis. It was developed in a conservative treatment setting for all type of spinal deformities, including also patients with surgical curves. The ISYQOL has recently been translated into English, however, its adaptation to the Turkish language is necessary for use in the Turkish population. The psychometric properties of any scale may be affected by translation into another language, that's why it is important for the scale to be evaluated psychometrically. Therefore, the purpose of this study was to translate the ISYQOL questionnaire to Turkish and to assess the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency and construct validity when used on patients with idiopathic scoliosis. Adolescent girls with idiopathic scoliosis who applied to Formed Scoliosis Treatment and Brace Center between September 2018 to 2020 are inviting in this stud by mailing
- Being tested
- Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
- Keywords
- Adolescent Idiopathic Scoliosis, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) QuestionnaireOther
Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
ISYQOL, is a 20-item tool used to assess spine health and health related quality of life in patients with spinal deformities. ISYQOL was developed according to Rasch analysis. Seven ISYQOL items assess the impact of bracing on quality of life and are to be administered only to people wearing the brace. Because of ISYOQL is a Rasch-consistent questionnaire, it allows the comparison of the HRQOL in AIS patients who wearing and not wearing the brace. Each item is rated on a 0-2 point Likert scale from never to often. Total scores range from 0 to 40. Lower scores on the ISYQOL indicate higher health-related quality of life
Measured: baseline
SRS-22 Patient Questionnaire
SRS-22 questionnaire was developed by SRS to evaluate health-related quality of life (HRQL) in patients with adolescent idiopathic scoliosis (AIS) and the Turkish version was validated in 2005. The SRS-22 questionnaire consists of 22 items Likert type scale that allows scoring between 1-5 for each question. SRS-22 has five domains including function, pain, mental health, self-image and satisfaction. Subgroups can be evaluated separately, or the total score is obtained by summing up the scores from all questions. The total score of each section ranges from 5 to 25, only the section evaluating satisfaction from the treatment is in the range of 2-10. Scoring is obtained by dividing the total score of each section by the number of questions in that section. Higher scores indicate better quality of life.
Measured: baseline
Re-Test Reliability of Turkish Version of ISYQOL Questionnaire
Test-retest reliability was assessed by calculating the intraclass correlation coefficient (ICC).ICC interpreted; proposed a classification for the strength of test-retest reliability based on the ICC as follows: less than 0.40 is poor, between 0.40-0.75 is fair to good and; more than 0.75 is excellent.
Measured: 4 weeks after from the first assessment
Secondary outcomes (1)
Cobb angle
Cobb angle is determinant of curvature severity which obtain from full spine PA radiographs.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start6 Jan 2019
- Primary completion7 Sep 2020
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hürriyet Yılmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Sponsor-investigator, Hürriyet Yılmaz, Halic University
- Investigators
- Ahsen Büyükaslan, PT,PhD(c), Principal investigator, Medipol UniversityHürriyet Yılmaz, MD, Prof., Study director, Halic UniversityMelek Güneş Yavuzer, MD, Prof., Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720677
- Sponsor's protocol ID
- HUEK172-31
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS
- ClinicalTrials.gov ID
- NCT04720677
- Acronym / sponsor ID
- HUEK172-31
- Keywords
- Adolescent Idiopathic Scoliosis, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hürriyet YılmazUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 Jan 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.
The ISYQOL questionnaire was translated into Turkish and was assessed the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency, and construct validity in this research.
Detailed description
HRQOL is considered one of the most relevant outcomes of both conservative and surgical treatment of scoliosis, for this reason, several questionnaires (e.g. SRS-24 and SRS-22) have been developed. SRS-22 has been reported as the most commonly used scale to measure HRQOL in patient with scoliosis in many countries. However, current literature showed that SRS-22 has poor measurement properties, it does not satisfy fundamental measure requirements, i.e. additivity, generalizability and unidimensionality. According to Rasch analysis study SRS-24 and SRS-22 presents high ceiling effects in conservative care, for the reason that was developed for surgical candidates. The Italian Spine Youth Quality of Life (ISYQOL) questionnaire originally in Italian, is the first HRQOL questionnaire developed according to the Rasch analysis. It was developed in a conservative treatment setting for all type of spinal deformities, including also patients with surgical curves. The ISYQOL has recently been translated into English, however, its adaptation to the Turkish language is necessary for use in the Turkish population. The psychometric properties of any scale may be affected by translation into another language, that's why it is important for the scale to be evaluated psychometrically. Therefore, the purpose of this study was to translate the ISYQOL questionnaire to Turkish and to assess the psychometric properties of the Turkish version of the ISYQOL in terms of test-retest reliability, internal consistency and construct validity when used on patients with idiopathic scoliosis. Adolescent girls with idiopathic scoliosis who applied to Formed Scoliosis Treatment and Brace Center between September 2018 to 2020 are inviting in this stud by mailing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Adolescent girls with idiopathic scoliosis
Key inclusion criteria (4 listed)
- who has diagnosed with AIS
- aged 10 to 18 years
- curvature between 10 ° to 45 ° ,
- native Turkish speaker adolescents who accepted to participate in the study and approved by their parents.
Key exclusion criteria (3 listed)
- non-idiopathic scoliosis
- history of spinal surgery,
- spinal trauma, tumor, infection
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 |
|---|---|---|
| Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) QuestionnaireTurkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire | Other | – |
Primary outcome
Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
Time frame: baseline
ISYQOL, is a 20-item tool used to assess spine health and health related quality of life in patients with spinal deformities. ISYQOL was developed according to Rasch analysis. Seven ISYQOL items assess the impact of bracing on quality of life and are to be administered only to people wearing the brace. Because of ISYOQL is a Rasch-consistent questionnaire, it allows the comparison of the HRQOL in AIS patients who wearing and not wearing the brace. Each item is rated on a 0-2 point Likert scale from never to often. Total scores range from 0 to 40. Lower scores on the ISYQOL indicate higher health-related quality of life
SRS-22 Patient Questionnaire
Time frame: baseline
SRS-22 questionnaire was developed by SRS to evaluate health-related quality of life (HRQL) in patients with adolescent idiopathic scoliosis (AIS) and the Turkish version was validated in 2005. The SRS-22 questionnaire consists of 22 items Likert type scale that allows scoring between 1-5 for each question. SRS-22 has five domains including function, pain, mental health, self-image and satisfaction. Subgroups can be evaluated separately, or the total score is obtained by summing up the scores from all questions. The total score of each section ranges from 5 to 25, only the section evaluating satisfaction from the treatment is in the range of 2-10. Scoring is obtained by dividing the total score of each section by the number of questions in that section. Higher scores indicate better quality of life.
Re-Test Reliability of Turkish Version of ISYQOL Questionnaire
Time frame: 4 weeks after from the first assessment
Test-retest reliability was assessed by calculating the intraclass correlation coefficient (ICC).ICC interpreted; proposed a classification for the strength of test-retest reliability based on the ICC as follows: less than 0.40 is poor, between 0.40-0.75 is fair to good and; more than 0.75 is excellent.
1 secondary outcome
Cobb angle
Time frame: baseline
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 21 Feb 2022.
- 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.
Ahsen Büyükaslan, PT,PhD(c) principal investigator
Medipol University
Hürriyet Yılmaz, MD, Prof. study director
Halic University
Melek Güneş Yavuzer, MD, Prof. study director
Halic University
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 and Health Related Quality of Life, run by Hürriyet Yılmaz 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 4 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 21 Feb 2022. 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?
Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.