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Duchenne Muscular DystrophyNCT06174025

Validity and Reliability of the 6 Minute Pegboard Ring Test

An observational study of Duchenne Muscular Dystrophy, run by Çağtay Maden at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD and its applicability on these patients. Read more about this study

Who is it for?
Ages 6 to 18 years, men only
Conditions the study is for
Duchenne Muscular Dystrophy
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Jun 2023to 1 Jan 2024
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 6 to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Study population: Individuals diagnosed with Duchenne muscular dystrophy

Who may be able to join

  • Volunteering to participate in the research,
  • Being diagnosed with Duchenne muscular dystrophy between the ages of 6-17,
  • Being Level 1 and 2 according to the Brooke Upper Extremity Functional Classification Scale
  • Having no problems reading and/or understanding the scales and cooperating with the tests to be.
  • Ability to sit independently for approximately 15 minutes during the evaluation

Who cannot join

  • Not volunteering to participate in the research,
  • Having any orthopedic problem in the upper extremity,
  • A neurological disease or other clinical condition that may affect cognitive status having a diagnosis,
  • Having had surgery on the upper extremities in the last 6 months and any having an injury
  • At a level that prevents functional activities in the upper extremity Having severe contractures (joint restriction)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gaziantep İslamic Science and Technology University

    Gaziantep, Şahinbey, 27000

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the 6 Minute Pegboard Ring Test in Duchenne Muscular Dystrophy Patients

This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD and its applicability on these patients.

Read the detailed description

Duchenne muscular dystrophy (DMD) is the most common type of progressive muscular dystrophies and is an X-linked recessive, rarely autosomal dominant, muscle disease. DMD begins in childhood and progresses until they become unable to walk. Individuals with DMD experience skeletal muscle weakness, difficulty breathing, and decreased exercise capacity. In these patients, traditionally lower extremity tests are; 6-minute walk tests, treadmill tests and Cardiopulmonary exercise tests are used. However, it is reported that the upper extremity is also affected in individuals with DMD. The 6-Minute Pegboard and Ring Test (6PBRT), which is valid and reliable in most disease groups, is also a test that can be applied to the upper extremities. It is important to use 6PBRT frequently in clinical research practice for patients with DMD and to know its validity and reliability. To our knowledge, the validity and reliability of this test in individuals with DMD has not been established in the literature. This study aimed to investigate the validity and reliability of 6PBRT in individuals with DMD and its applicability on these patients.

Keywords
Duchenne Muscular Dystrophy, 6 Minute Pegboard and Ring Test, arm exercise endurance, upper extremity
Medical subject headings
Muscular Dystrophy, Duchenne

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minute Pegboard and Ring Test

    The 6-minute pegboard and ring test is used to assess upper extremity functional capacity. The patient sat in front of a perforated board with bottom pegs at shoulder level. The upper pegs are placed in the hole 20 cm above the lower pegs. 10 rings of the same size are placed on the lower pegs. The patient is asked to move as many rings as possible from the lower pegs to the upper pegs and vice versa within a 6-minute period. Pulse, blood pressure, SpO₂, dyspnea and arm fatigue detection are recorded before/after each test. Before the actual test, patients are allowed to move up and down the rings in a cycle to become familiar with the testing procedure. If the patient wants to rest during the test, he is allowed, but the stopwatch is not stopped. During the test, standard encouraging phrases are said to the patient at the end of each minute.

    Measured: A total of two measurements will be made at 1-week intervals within 6 months.

Secondary outcomes (4)

  1. Quick Shoulder-Hand Syndromes Questionnaire

    The Quick Shoulder-Hand Syndromes Questionnaire is used to evaluate musculoskeletal physical function and symptoms of the upper extremity. The survey consists of 11 items and is scored between 0-100 points. Higher scores indicate more disability

    Measured: A total of two measurements will be made at 1-week intervals within 6 months.

  2. Assessment of muscle strength

    Muscle strength will be measured using a digital dynamometer (Manual Muscle Tester™), shoulder flexor, shoulder abductor, elbow extensor and elbow flexor muscle strength. Muscle tests will be repeated three times for each side and the highest value will be recorded in kg. Muscle strength will be calculated as percentages of expected values.

    Measured: A total of two measurements will be made at 1-week intervals within 6 months.

  3. The Pediatric Quality of Life Inventory

    The health-related quality of life of the participants will be evaluated with the Turkish version PedsQL-3.0 Neuromuscular Module. The scale consists of 3 categories containing 25 items. These categories; It includes 17 items regarding the disease process and related symptoms, 3 items regarding communication skills, and 5 items regarding the family's financial and social support systems. The items of the scale are scored between 4 (always poses a problem) and 0 (never poses a problem). At the end of the scale, a score between 0 and 4 is made. A score close to 100 indicates that the health-related quality of life is at a better level.

    Measured: A total of two measurements will be made at 1-week intervals within 6 months.

  4. Brooke Upper Extremity Functional Classification Scale

    It will be used to evaluate the upper extremity functional level of the individuals who will be included in the study. It was developed to determine the functional level of the upper extremity in the clinical evaluation of DMD (11). The steps of this scale are as follows; Level 1: Begins to move with the arms at the sides and can fully clasp the hands above the head.

    Level 2: However, he can bring his arms above his head by flexing his elbows or use his accessory muscles Level 3: He cannot raise his hands above his head, but he can bring the glass to his mouth (uses both hands if necessary).

    Level 4: He can raise his hands to his mouth, but cannot lift a glass of water to his mouth.

    Level 5: Cannot raise hands to mouth, but can raise hands to hold a pen or pick up a coin from the table.

    Level 6: He cannot raise his hands up to his mouth and cannot use his hands functionally.

    Measured: A total of two measurements will be made at 1-week intervals within 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start30 Jun 2023
  3. Primary completion30 Dec 2023
  4. Study completion1 Jan 2024

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06174025
Sponsor's protocol ID
2023/236
Status last verified
May 2023
First submitted
20 Nov 2023
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Maden C, Karabulut DG, Yigit S. Validity and Reliability of the 6-min Pegboard and Ring Test in Patients With Duchenne Muscular Dystrophy. Muscle Nerve. 2025 Feb;71(2):200-207. doi: 10.1002/mus.28314. Epub 2024 Dec 11.

    PubMed 39660725

Questions about this trial

What is this clinical trial studying?

An observational study of Duchenne Muscular Dystrophy, run by Çağtay Maden 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 5 inclusion and 5 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 12 Jan 2024. 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?

6 Minute Pegboard and Ring Test (time frame: A total of two measurements will be made at 1-week intervals within 6 months.). 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 NCT06174025, 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 12 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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