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

NCT05539456 | Unknown

• 1 other identifier: E-10840098-772.02-213
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Spinal Muscular Atrophy; Quality of Life; Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• PedsQLTM 3.0 neuromuscular module for 2-to 4- Year-old

  The module encompasses three scales: 1. About My/My Child's Neuromuscular Disease (17 items), 2. Communication (3 items), 3. 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 Outcomes (1)

• PedsQLTM 4.0 generic core scales

  5-10 minutes

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with spinal muscular atrophy between 2 to 4 years age.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Seval Kutlutürk Yıkılmaz

Istanbul, Kavacık, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases

Study Officials

• Seval Kutlutürk Yıkılmaz

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

TU (1)