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OpenTrials
Completed

NCT Number: NCT04720677

Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Health Related Quality of Life

Age range

10 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Formed Healthcare Scoliosis Brace and Treatment Center

Istanbul, 34371, Turkey (Türkiye)

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • non-idiopathic scoliosis
  • history of spinal surgery,
  • spinal trauma, tumor, infection

Treatment and study plan

Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire

Other

Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Cobb angle

    Time frame: baseline

    Cobb angle is determinant of curvature severity which obtain from full spine PA radiographs.

Sponsors and collaborators

Lead sponsor

Hürriyet Yılmaz

Other

Collaborators

  • Medipol University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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