Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old

Quality of Life Clinical Trial

Official title:

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old: a Quality-of-life Measure for Patients With Spinal Muscular Atrophy in Turkey

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05539456
• Other study ID #: E-10840098-772.02-213
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the investigator's study was to investigate translating the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old and using it in clinics reliably and validity with a Turkish version of the PedsQL Generic Core (Pediatric Quality of Life Questionnare) in children with Spinal Muscular Atrophy in Turkey

Description:

The PedsQL 3.0 Neuromuscular Module for 2-to 4- year-old will be translated into Turkish by following the language translation steps. First of all, the English form will be translated into Turkish by two people who are fluent in English. Then, the forms translated by another expert in the field will be reviewed. The revised text will be translated from Turkish into English by another person with a good command of English and will be compared with the original scale by the lecturer. If a significant change in meaning is not detected, the scale will be applied to 10 parents. In case of incomprehensible questions, which are reported to be lacking in expression, the scale will be finalized after revision and corrections are made by the research team.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 55
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• Having a child with spinal muscular atrophy
• Having a child between the ages of 2-4
• Accept to participate in the study

Exclusion Criteria:

• Lack of cooperation during work
• Presence of disease other than SMA, which will prevent participation in the study

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Neuromuscular Diseases
• Pediatric Disorder
• Quality of Life
• Spinal Muscular Atrophy

Locations

Country	Name	City	State
Turkey	Seval Kutlutürk Yikilmaz	Istanbul	Kavacik

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PedsQLTM 3.0 neuromuscular module for 2-to 4- Year-old	The module encompasses three scales: About My/My Child's Neuromuscular Disease (17 items),; Communication (3 items),; About Our Family Resources (5 items).; The scale is comprised a parent proxy-report format for children ages 2 to 4 years.; Items in all forms are essentially identical but contain slightly different language for first or third person tense.; The participants are asked how much of a problem each item had been during the past month.; Responses are rated on a 5-point Likert scale across child self-report for children, teens, and parent proxy-reports (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem).; Items are linearly transformed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better HRQOL.	5-10 minutes
Secondary	PedsQLTM 4.0 generic core scales	The 23-item PedsQLTM 4.0 Generic Core Scales encompass: Physical Functioning (8 items),; Emotional Functioning (5 items),; Social Functioning (5 items),; School Functioning (5 items); The formats, instructions, Likert scales, and scoring methods are the same as those of the PedsQLTM 3.0 Neuromuscular Module. To create the Psychosocial Health Summary Score, the mean is computed as the sum of the items divided by the number of items answered in the Emotional, Social, and School Functioning Subscales.	5-10 minutes