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

NCT04720677 | Completed

• 1 other identifier: HUEK172-31
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis; Health Related Quality of Life

Keywords

Adolescent Idiopathic Scoliosis; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  4 weeks after from the first assessment

Secondary Outcomes (1)

• Cobb angle

  baseline

Interventions

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

Eligibility Criteria

• Age: 10 Years - 18 Years
• Gender Eligibility Details: Investigators could not analyze the sex-related difference in this study. In clinical practice, investigators have more female cases and they could not reach a male sample large enough to compare with them.
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent girls with idiopathic scoliosis

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hürriyet Yılmaz: lead
• Medipol University: collaborator

Study Sites (1)

Formed Healthcare Scoliosis Brace and Treatment Center

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ahsen Büyükaslan, PT,PhD(c)

  Medipol University

  PRINCIPAL INVESTIGATOR

• Hürriyet Yılmaz, MD, Prof.

  Halic University

  STUDY DIRECTOR

• Melek Güneş Yavuzer, MD, Prof.

  Halic University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.Prof.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: January 6, 2019
• Primary Completion: September 7, 2020
• Study Completion: January 30, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)