Skip to main content
OpenTrials
Completed

NCT Number: NCT05549999

Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment

The aim of this study is to translate the "North Star Ambulatory Assessment (NSAA)" scale into Turkish and make its cultural adaptation and to demonstrate the reliability and validity of the Turkish version in patients with ambulatory DMD. For the translation into Turkish, validity and reliability of the NSAA, necessary permission was obtained from the developer of the questionnaire, Prof. Dr. Francesco Muntoni, via e-mail. In the study, first of all, the translation and cultural adaptation process will be completed, and then reliability-validity studies will be carried out.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being diagnosed with DMD
  • Ambulatory
  • Being between the ages of 4-18
  • Agreeing to participate in the research voluntarily

Exclusion criteria

  • Insufficient cooperation with the physiotherapist,
  • Have had any injury and/or surgery of the lower extremities in the last 6 months,
  • Having neurological problems in addition to DMD. -

Treatment and study plan

North Star Ambulatory Assessment

Diagnostic Test

North Star Ambulatory Assessment is an ambulatory assessment developed specifically for Duchenne Muscular Dystrophy.

Primary outcomes

  1. North Star Ambulatory Assessment

    Time frame: 10 minutes

    The North Star Ambulatory Assessment (NSAA) is a functional scale specifically designed for ambulant boys with DMD. The instrument contains clear and detailed instructions, with item scores varying according to a simple three point criteria, which should allow accurate reproduction by different groups. The scale has also the advantage to be quick to perform and to be suitable for application in young children. The NSAA also includes two timed items, run/walk for 10 meters and rise from the floor. While those times do not influence the score, they can be used to monitor changes over time. Although it was developed to assess ambulatory patients, the NSAA has been widely accepted and used to evaluate ambulatory motor performance in children and young adults with DMD, as well as in patients with other neuromuscular diseases.

Secondary outcomes

  1. Motor Function Measure (MFM)

    Time frame: 20-30 minutes

    MFM, which was valid and reliable in Neuromuscular Diseases, was used for gross motor function assessment. The items in MFM, which evaluate functions in 3 different sections (D1, standing position and transfers; D2, axial and proximal motor function; D3, distal motor function) in 32 items in total, are scored between 0-3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the exercise, 2; performs the exercise slowly and visibly clumsily, with compensations, 3; performs the exercise in the specified standard pattern. High scores indicate higher motor function and the result is expressed as a percentage of the maximum possible score to enable comparison with other scores

  2. 6 meter walking test (6MWT)

    Time frame: 6 minutes

    6MWT is an assessment that was developed by Balke in the 1960s and has validity and reliability for DMD patients. The maximum distance that the patient can walk in 6 minutes is recorded as meters.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.