NCT07435116

Brief Summary

Muscular dystrophies are hereditary and progressive skeletal muscle diseases that cause degeneration and loss of strength in the muscles. The most common form is Duchenne Muscular Dystrophy (DMD), which is X-linked recessive and develops due to a mutation in the dystrophin gene. Dystrophin is a membrane protein found in skeletal muscle, cardiac muscle, vascular smooth muscle, and the brain, functioning as a component of the glycoprotein complex. In the absence of dystrophin, proteases break down the glycoprotein complex, resulting in the loss of membrane proteins, which leads to degeneration and weakness of muscle fibres. In addition to skeletal muscle, involvement of the respiratory and cardiac muscles is the most important cause of morbidity and mortality. Children with DMD are usually diagnosed with abnormal gait, frequent falls, and difficulty climbing stairs. Progressive functional loss is observed over time. Although the disease usually begins in the lower extremities, it eventually affects the upper extremities as well. Early stage: Lower extremity muscles are more affected (walking and climbing stairs become difficult). Advanced stages: Shoulder girdle, arm, and hand muscles begin to be affected. Weakness is particularly seen in the deltoid, biceps, and triceps muscles. There is limited shoulder movement and difficulty raising the arm. Therefore, functional losses are seen in the upper extremities. Functional losses generally cause difficulties in daily living activities; tasks requiring upper limb use, such as dressing, eating, and combing hair, become difficult. Hand skills (fine motor functions) are usually affected later, but distal muscles may also weaken over time. In summary, upper limb muscles weaken in individuals with DMD as the disease progresses. This can affect the individual's daily living activities. Regular monitoring of upper limb function, appropriate rehabilitation programmes, and supportive treatments aimed at improving quality of life are of great importance.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

duchenne muscular dystrophyviscoelastic property

Outcome Measures

Primary Outcomes (5)

  • Myoton Pro:

    In our study, we will use the MyotonPRO device to measure the passive mechanical properties (muscle tone, stiffness, elasticity) of our target muscles . Target Muscle Groups: The biceps brachii, triceps brachii, deltoid (anterior portion), and extensor digitorum muscles will be measured. MyotonPRO Measurement Procedure: Participants will be assessed in a seated or supine position. Measurements will be taken from the dominant limb. Three repetitions will be taken for each muscle, and the average value will be used in the analysis. Measurements should be taken at rest.

    3 months

  • Nine Hole Peg Test

    Instruct the patient to use the hand being assessed to take the pegs out of the container one by one as quickly as possible and place them into the holes on the board. Then instruct the patient to remove the pegs from the holes one by one and place them back into the container. Start the stopwatch when the patient touches the first peg and stop it when the last peg is placed in the container. Score the patient based on how many seconds it took to complete the test. Alternatively, the number of pegs placed within 50 or 100 seconds can be recorded. In this case, the results are expressed as the number of pegs placed per second.

    3 months

  • 6-Minute Pegboard Test (6PBRT)

    This test is a commonly used tool for assessing upper extremity function. During the test, participants attempt to place the pegs from the bottom two rows onto the pegs in the top row as quickly as possible for 6 minutes. This process tests both hand-eye coordination and fine motor skills.

    3 months

  • Manual muscle testing device

    Muscle strength in the dominant upper extremity, including the shoulder, elbow, wrist, and finger flexor and extensor muscles, will be measured using the Commander Echo brand manual muscle testing device. The participant will be asked to resist as much as possible, and the maximum force will be recorded. After informing the participants, one trial will be conducted. The muscle strength measurement will be repeated three times, and the average value will be recorded in kilograms.

    3 months

  • SF-12

    a short and practical measurement tool used to assess health-related quality of life. It is a self-reported outcome measure that assesses the impact on an individual's daily life. It is commonly used as a measure of quality of life. The SF-12 is a shortened version of the SF-36, which was developed from the Medical Outcomes Study. The SF-12 was developed by Ware and colleagues after 10 years of experience.

    3 months

Study Arms (1)

group of children with Duchenne muscular atrophy

Eligibility Criteria

Age5 Years - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male children were included in the study because Duchenne Muscular Dystrophy is an X-linked disorder that occurs almost exclusively in males. Therefore, male participants were targeted for the study to examine the viscoelastic properties of the upper limb muscles.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Duchenne Muscular Dystrophy

You may qualify if:

  • Individuals with a genetically or biopsy-confirmed diagnosis of DMD.
  • Individuals for whom family consent has been obtained

You may not qualify if:

  • Individuals with orthopaedic deformities, trauma or surgery in the upper extremities
  • Individuals with serious cardiopulmonary complications
  • Individuals with another neurological disease that may affect muscle tone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, Gaziantep, 27090, Turkey (Türkiye)

Location

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 Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dırector

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 27, 2026

Study Start

November 1, 2025

Primary Completion

January 15, 2026

Study Completion

March 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations