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Clinical Trials/NCT05549999
NCT05549999
Completed
N/A

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

Hacettepe University1 site in 1 country86 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
Hacettepe University
Enrollment
86
Locations
1
Primary Endpoint
North Star Ambulatory Assessment
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
May 25, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Güllü AYDIN YAĞCIOĞLU

Research Asisstant

Suleyman Demirel University

Eligibility Criteria

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. -

Outcomes

Primary Outcomes

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

  • 6 meter walking test (6MWT)(6 minutes)
  • Motor Function Measure (MFM)(20-30 minutes)

Study Sites (1)

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