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

NCT ID: NCT05539456

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-11-01

Brief 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

Detailed 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.

Conditions

Spinal Muscular Atrophy; Quality of Life; Neuromuscular Diseases; Pediatric Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seval Kutlutürk Yıkılmaz

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Seval Kutlutürk Yıkılmaz

Istanbul, Kavacık, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-213

Identifier Type: -

Identifier Source: org_study_id