Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS
NCT number | NCT04720677 |
Other study ID # | HUEK172-31 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 6, 2019 |
Est. completion date | January 30, 2022 |
Verified date | February 2022 |
Source | Halic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | January 30, 2022 |
Est. primary completion date | September 7, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 10 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Formed Healthcare Scoliosis Brace and Treatment Center | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Hürriyet Yilmaz | Medipol University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Cobb angle | Cobb angle is determinant of curvature severity which obtain from full spine PA radiographs. | baseline |
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