Validity and Reliability of the 6 Minute Pegboard Ring Test

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06174025
• Other study ID #: 2023/236
• Status: Completed
• Start date: June 30, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: Gaziantep Islam Science and Technology University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Locations

Country	Name	City	State
Turkey	Gaziantep Islamic Science and Technology University	Gaziantep	Sahinbey

Sponsors (1)

Lead Sponsor	Collaborator
Çagtay Maden

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	A total of two measurements will be made at 1-week intervals within 6 months.
Secondary	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	A total of two measurements will be made at 1-week intervals within 6 months.
Secondary	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.	A total of two measurements will be made at 1-week intervals within 6 months.
Secondary	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.	A total of two measurements will be made at 1-week intervals within 6 months.
Secondary	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.	A total of two measurements will be made at 1-week intervals within 6 months.