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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549999
• Other study ID #: NSAA-123
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: July 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 25, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 4 Years to 18 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Ambulation Difficulty
• Duchenne Muscular Dystrophy
• Gait Disorders, Neurologic
• Mobility Limitation
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Nervous System Diseases

Intervention

Diagnostic Test:
• North Star Ambulatory Assessment
North Star Ambulatory Assessment is an ambulatory assessment developed specifically for Duchenne Muscular Dystrophy.

Locations

Country	Name	City	State
Turkey	Güllü Aydin Yagcioglu	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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