Duchenne Muscular Dystrophy (DMD)NCT07435116
Duchenne Muscular Dystrophy and the Viscoelastic Properties of Upper Limb Muscles
An observational study of Duchenne Muscular Dystrophy (DMD) and Viscoelastic Property, run by Sanko University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD), Viscoelastic Property
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Duchenne Muscular Dystrophy
Who may be able to join
- Individuals with a genetically or biopsy-confirmed diagnosis of DMD.
- Individuals for whom family consent has been obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Viscoelastic Properties of Upper Extremity Muscles in Patients With Duchenne Muscular Dystrophy
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.
Read the detailed description
Due to the rapid progression of muscle weakness and accompanying contractures, children often become dependent on wheelchairs by the age of 12. Loss of ambulation, muscle weakness and atrophy progress rapidly, leading to limited movement and contractures in the lower limbs. The same processes are observed in the upper limb muscles following the lower limbs. With the decline in upper limb function towards the middle of the first decade, children lose their feeding and self-care skills. The progression of weakness continues into the second decade. The function of the distal muscles is often preserved enough to allow the use of eating utensils, a pen, or a computer keyboard. Regular monitoring of upper limb function, appropriate rehabilitation programmes, and supportive treatments aimed at improving quality of life are of great importance. The most important things that can be done for this disease are the treatment of complications and improving the quality of life of affected children. Muscle and connective tissue are referred to as 'viscoelastic' tissues because they possess both viscosity and elasticity properties. Very rigid structures are more viscous and less elastic, while soft structures are more elastic and less viscous.
Myotonometry allows us to objectively and quantitatively examine parameters such as the passive stiffness, elasticity, and tone of upper limb muscles, thereby making a significant contribution to current clinical assessments. This enables us to go beyond subjective evaluations and allows for more sensitive monitoring of progressive changes. Myotonometry has generally been used in healthy individuals or in neurological/rheumatological diseases. However, its use in DMD, particularly for upper limb muscles, is limited in the literature. Therefore, your study could be a pioneering work demonstrating the specific applications of the myotonometry device in DMD. This study will be conducted at the Gaziantep Metropolitan Municipality Disability-Free Living Centre. The study is planned as an observational, cross-sectional descriptive study to examine the myotonometric characteristics of the upper limb muscles in individuals diagnosed with Duchenne Muscular Dystrophy (DMD). It is a cross-sectional descriptive study. Thirty male individuals aged 5-18 years with a genetically or biopsy-confirmed diagnosis of DMD will be included in the study. These individuals will be categorised into three groups: 5-8, 9-12, and 13-17 years of age and compared with a healthy peer group. Healthy peers will include children and relatives of academic and administrative staff of the SANKO University Faculty of Health Sciences. As individuals in both groups are under 18 years of age, voluntary consent forms will also be obtained from their families. Only the dominant extremity of each individual included in the study will be measured.
For those participating in the study, demographic information forms and voluntary consent forms will first be completed by their families. Subsequently, for our assessments, the Myoton PRO device will be used to measure the passive mechanical properties (muscle tone, stiffness, elasticity) of our target muscles. To assess upper limb functionality: Nine-Hole PEG Test and 6-Minute Pegboard Test. To assess muscle strength: Muscle Tester (Manual Muscle Testing Device). To assess quality of life: SF-12 Quality of Life Scale.
Assessments will take approximately 30 minutes. Rest periods will be included to prevent fatigue. Families will be present in the assessment environment during the assessments.
- Keywords
- duchenne muscular dystrophy, viscoelastic property
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group of children with Duchenne muscular atrophy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Nov 2025
- Primary completion15 Jan 2026
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435116
- Sponsor's protocol ID
- hakanpolat12
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Viscoelastic Properties of Upper Extremity Muscles in Patients With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT07435116
- Acronym / sponsor ID
- hakanpolat12
- Keywords
- duchenne muscular dystrophy, viscoelastic property
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
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.
Detailed description
Due to the rapid progression of muscle weakness and accompanying contractures, children often become dependent on wheelchairs by the age of 12. Loss of ambulation, muscle weakness and atrophy progress rapidly, leading to limited movement and contractures in the lower limbs. The same processes are observed in the upper limb muscles following the lower limbs. With the decline in upper limb function towards the middle of the first decade, children lose their feeding and self-care skills. The progression of weakness continues into the second decade. The function of the distal muscles is often preserved enough to allow the use of eating utensils, a pen, or a computer keyboard. Regular monitoring of upper limb function, appropriate rehabilitation programmes, and supportive treatments aimed at improving quality of life are of great importance. The most important things that can be done for this disease are the treatment of complications and improving the quality of life of affected children. Muscle and connective tissue are referred to as 'viscoelastic' tissues because they possess both viscosity and elasticity properties. Very rigid structures are more viscous and less elastic, while soft structures are more elastic and less viscous.
Myotonometry allows us to objectively and quantitatively examine parameters such as the passive stiffness, elasticity, and tone of upper limb muscles, thereby making a significant contribution to current clinical assessments. This enables us to go beyond subjective evaluations and allows for more sensitive monitoring of progressive changes. Myotonometry has generally been used in healthy individuals or in neurological/rheumatological diseases. However, its use in DMD, particularly for upper limb muscles, is limited in the literature. Therefore, your study could be a pioneering work demonstrating the specific applications of the myotonometry device in DMD. This study will be conducted at the Gaziantep Metropolitan Municipality Disability-Free Living Centre. The study is planned as an observational, cross-sectional descriptive study to examine the myotonometric characteristics of the upper limb muscles in individuals diagnosed with Duchenne Muscular Dystrophy (DMD). It is a cross-sectional descriptive study. Thirty male individuals aged 5-18 years with a genetically or biopsy-confirmed diagnosis of DMD will be included in the study. These individuals will be categorised into three groups: 5-8, 9-12, and 13-17 years of age and compared with a healthy peer group. Healthy peers will include children and relatives of academic and administrative staff of the SANKO University Faculty of Health Sciences. As individuals in both groups are under 18 years of age, voluntary consent forms will also be obtained from their families. Only the dominant extremity of each individual included in the study will be measured.
For those participating in the study, demographic information forms and voluntary consent forms will first be completed by their families. Subsequently, for our assessments, the Myoton PRO device will be used to measure the passive mechanical properties (muscle tone, stiffness, elasticity) of our target muscles. To assess upper limb functionality: Nine-Hole PEG Test and 6-Minute Pegboard Test. To assess muscle strength: Muscle Tester (Manual Muscle Testing Device). To assess quality of life: SF-12 Quality of Life Scale.
Assessments will take approximately 30 minutes. Rest periods will be included to prevent fatigue. Families will be present in the assessment environment during the assessments.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of children with Duchenne muscular atrophy | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Duchenne Muscular Dystrophy
Key inclusion criteria (2 listed)
- Individuals with a genetically or biopsy-confirmed diagnosis of DMD.
- Individuals for whom family consent has been obtained
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myoton Pro:
Time frame: 3 months
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.
Nine Hole Peg Test
Time frame: 3 months
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.
6-Minute Pegboard Test (6PBRT)
Time frame: 3 months
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.
Manual muscle testing device
Time frame: 3 months
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.
SF-12
Time frame: 3 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (DMD) and Viscoelastic Property, run by Sanko 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 2 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Myoton Pro: (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.