Clinical trial NCT04720677: Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS
Official title: Psychometric Properties of Adapted Turkish Version of ISYQOL Questionnaire in Patients With AIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Health Related Quality of Life
Keywords: Adolescent Idiopathic Scoliosis
Quality of Life
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2021-01-22
Enrollment: 78
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent girls with idiopathic scoliosis

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
timeFrame: baseline
measure: SRS-22 Patient Questionnaire
timeFrame: baseline
measure: Re-Test Reliability of Turkish Version of ISYQOL Questionnaire
timeFrame: 4 weeks after from the first assessment
Secondary outcomes:
measure: Cobb angle
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Formed Healthcare Scoliosis Brace and Treatment Center
Study officials:
affiliation: Medipol University
name: Ahsen Büyükaslan, PT,PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Hürriyet Yılmaz, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Halic University
name: Melek Güneş Yavuzer, MD, Prof.
role: STUDY_DIRECTOR
References: