NCT06174025

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

November 20, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

Duchenne Muscular Dystrophy6 Minute Pegboard and Ring Testarm exercise enduranceupper extremity

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Quick Shoulder-Hand Syndromes Questionnaire

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

  • Assessment of muscle strength

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

  • The Pediatric Quality of Life Inventory

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

  • Brooke Upper Extremity Functional Classification Scale

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

Eligibility Criteria

Age6 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with Duchenne muscular dystrophy

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep İslamic Science and Technology University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Çağtay MADEN, PhD

    Gaziantep İslamic Science and Technology University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 18, 2023

Study Start

June 30, 2023

Primary Completion

December 30, 2023

Study Completion

January 1, 2024

Last Updated

January 12, 2024

Record last verified: 2023-05

Locations