Duchenne Muscular DystrophyNCT05549999
Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment
An observational study of Duchenne Muscular Dystrophy and Ambulation Difficulty, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Ambulation Difficulty, Ambulation Disorder, Neurologic
- What is being tested?
- North Star Ambulatory Assessment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 25 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Study population include just ambulatory patients with Duchenne Muscular Dystrophy
Who may be able to join
- Being diagnosed with DMD
- Ambulatory
- Being between the ages of 4-18
- Agreeing to participate in the research voluntarily
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- North Star Ambulatory Assessment
- Keywords
- Duchenne Muscular Dystrophy, Ambulation, reliability, validity
- Medical subject headings
- Muscular Dystrophy, Duchenne, Mobility Limitation, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
North Star Ambulatory AssessmentDiagnostic test
North Star Ambulatory Assessment is an ambulatory assessment developed specifically for Duchenne Muscular Dystrophy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (2)
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
Measured: 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.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Nov 2022
- Primary completion25 Mar 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü AYDIN YAĞCIOĞLU, Suleyman Demirel University
- Investigators
- Güllü Aydın Yağcıoğlu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549999
- Sponsor's protocol ID
- NSAA-123
- Status last verified
- Jul 2023
- First submitted
- 19 Sep 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39436553
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment
- ClinicalTrials.gov ID
- NCT05549999
- Acronym / sponsor ID
- NSAA-123
- Keywords
- Duchenne Muscular Dystrophy, Ambulation, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Study population include just ambulatory patients with Duchenne Muscular Dystrophy
Key inclusion criteria (4 listed)
- Being diagnosed with DMD
- Ambulatory
- Being between the ages of 4-18
- Agreeing to participate in the research voluntarily
Key exclusion criteria (3 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| North Star Ambulatory AssessmentNorth Star Ambulatory Assessment is an ambulatory assessment developed specifically for Duchenne Muscular Dystrophy. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Motor Function Measure (MFM)
Time frame: 20-30 minutes
6 meter walking test (6MWT)
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 39436553Aydin-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Güllü Aydın Yağcıoğlu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy and Ambulation Difficulty, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
North Star Ambulatory Assessment (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.