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.

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy; Ambulation Difficulty; Ambulation Disorder, Neurologic
• Intervention / Treatment: Diagnostic test: North Star Ambulatory Assessment

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32100
    • Güllü Aydın Yağcıoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population include just ambulatory patients with Duchenne Muscular Dystrophy

Description

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. -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Function Measure (MFM)	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	20-30 minutes
6 meter walking test (6MWT)	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.	6 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Güllü Aydın Yağcıoğlu, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 25, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Duchenne Muscular Dystrophy; validity; Ambulation; reliability
• Additional Relevant MeSH Terms: Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Nervous System Diseases; Muscular Dystrophy, Duchenne; Gait Disorders, Neurologic; Mobility Limitation
• Other Study ID Numbers: NSAA-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No