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

NCT05549999 | Completed

• 1 other identifier: NSAA-123
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy; Ambulation Difficulty; Ambulation Disorder, Neurologic

Keywords

Duchenne Muscular Dystrophy; Ambulation; reliability; validity

Outcome Measures

Primary Outcomes (1)

• North Star Ambulatory Assessment

  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.

  10 minutes

Secondary Outcomes (2)

• Motor Function Measure (MFM)

  20-30 minutes

• 6 meter walking test (6MWT)

  6 minutes

Interventions

North Star Ambulatory Assessment DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population include just ambulatory patients with Duchenne Muscular Dystrophy

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Location

Related Publications (1)

• Aydin-Yagcioglu G, Bulut N, Ugur F, Yilmaz O, Alemdaroglu-Gurbuz I. Cultural adaptation, validity and reliability of the Turkish version of north star ambulatory assessment. Acta Neurol Belg. 2025 Feb;125(1):127-132. doi: 10.1007/s13760-024-02670-2. Epub 2024 Oct 22.

  PMID: 39436553 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Mobility Limitation; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Güllü Aydın Yağcıoğlu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: November 1, 2022
• Primary Completion: March 25, 2023
• Study Completion: May 25, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

TU (1)