Duchenne Muscular Dystrophy (DMD)NCT07437378
Relation Between Muscle Architecture and Functional Ability in Children With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy (DMD) and Neuromuscular Disorders, run by Deraya University at 1 site in Egypt.
Trial summary
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle degeneration, pseudohypertrophy, and declining functional mobility. This cross-sectional observational study investigates the relationship between gastrocnemius muscle architecture and functional ability in… Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD), Neuromuscular Disorders, Muscle Architecture
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 10 Nov 2025
- 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 12 years
- Men only
- No healthy volunteers
- Child
Study population: Male children aged 6 to 12 years diagnosed with Duchenne Muscular Dystrophy who were ambulatory and recruited from outpatient pediatric physical therapy clinics. Participants met specific inclusion criteria including Vignos Scale grades 1 to 7 and presence of calf pseudohypertrophy. All participants underwent a single assessment session to evaluate gastrocnemius muscle architecture and functional ability. No therapeutic intervention was administered.
Who may be able to join
- Diagnosed with Duchenne Muscular Dystrophy
- Age 6-12 years
- Ambulatory
- Vignos Scale grades 1-7
- Presence of calf pseudohypertrophy
- Absence of severe cardiac or pulmonary disease
Who cannot join
- Non-ambulatory
- Severe cognitive impairment
- History of lower limb trauma or fracture
- Inability to cooperate with assessment
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Deraya university, faculty of physical therapy
Minya, Menia Governorate
About this study
Official title: Relation Between Gastrocnemius Muscle Architecture and Functional Ability in Ambulatory Children With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle degeneration, pseudohypertrophy, and declining functional mobility. This cross-sectional observational study investigates the relationship between gastrocnemius muscle architecture and functional ability in ambulatory children with DMD. Muscle thickness and fascicle length were assessed using ultrasonography and correlated with motor function and ankle plantarflexion during gait.
Read the detailed description
Duchenne Muscular Dystrophy (DMD) is a genetic neuromuscular disorder characterized by progressive muscle degeneration, fatty infiltration, fibrosis, and loss of functional capacity during childhood. Although pseudohypertrophy may cause apparent enlargement of calf muscles, structural changes do not necessarily reflect muscle quality or functional performance.
This cross-sectional observational study included 26 ambulatory male children aged 6 to 12 years diagnosed with DMD. Participants underwent a single comprehensive assessment session.
Muscle architecture of the medial gastrocnemius muscle was evaluated using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe) to measure muscle thickness and fascicle length.
Functional ability was assessed using:
- The Motor Function Measure (MFM-32)
- The Vignos Scale
- Timed 10-Meter Walk Test
Ankle plantarflexion range of motion during gait was measured using Kinovea motion analysis software with 2D digital video analysis.
Correlation analysis was performed to determine the relationship between muscle architectural parameters and functional ability measures.
No therapeutic intervention, randomization, or group allocation was performed.
- Medical subject headings
- Muscular Dystrophy, Duchenne, Neuromuscular Diseases
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 |
|---|---|---|
| Ambulatory Children With Duchenne Muscular Dystrophy | Male children aged 6 to 12 years diagnosed with Duchenne Muscular Dystrophy and able to ambulate. Participants underwent assessment of gastrocnemius muscle architecture using ultrasonography and evaluation of functional ability using standardized outcome measures during a single assessment session. No intervention was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrocnemius Muscle Thickness and Fascicle Length
Measured using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe).
Measured: Baseline
Functional Ability (Motor Function Measure-32)
Functional performance was assessed using the Motor Function Measure-32 scale.
Measured: Baseline
Ankle Plantarflexion Range of Motion During Gait
Measured using Kinovea 2D motion analysis software.
Measured: Baseline
Timed 10-Meter Walk Test
Time required to walk 10 meters is used to assess ambulatory performance.
Measured: Baseline
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 start10 Sep 2024
- Primary completion31 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437378
- Sponsor's protocol ID
- DU-PT-DMD-ARCH-001
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaudreault N, Gravel D, Nadeau S, Houde S, Gagnon D. Gait patterns comparison of children with Duchenne muscular dystrophy to those of control subjects considering the effect of gait velocity. Gait Posture. 2010 Jul;32(3):342-7. doi: 10.1016/j.gaitpost.2010.06.003.
PubMed 20599384de Lattre C, Payan C, Vuillerot C, Rippert P, de Castro D, Berard C, Poirot I; MFM-20 Study Group. Motor function measure: validation of a short form for young children with neuromuscular diseases. Arch Phys Med Rehabil. 2013 Nov;94(11):2218-26. doi: 10.1016/j.apmr.2013.04.001. Epub 2013 Apr 18.
PubMed 23602884Darras, B. T., et al. (2014). Neuromuscular disorders of infancy, childhood, and adolescence: a clinician's approach, Elsevier.
Bulut N, Karaduman A, Alemdaroglu-Gurbuz I, Yilmaz O, Topaloglu H, Ozcakar L. Ultrasonographic assessment of lower limb muscle architecture in children with early-stage Duchenne muscular dystrophy. Arq Neuropsiquiatr. 2022 May;80(5):475-481. doi: 10.1590/0004-282X-ANP-2021-0038.
PubMed 35195227Berard C, Payan C, Hodgkinson I, Fermanian J; MFM Collaborative Study Group. A motor function measure for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005 Jul;15(7):463-70. doi: 10.1016/j.nmd.2005.03.004.
PubMed 16106528Akat A, Karaoz E. Cell Therapy Strategies on Duchenne Muscular Dystrophy: A Systematic Review of Clinical Applications. Stem Cell Rev Rep. 2024 Jan;20(1):138-158. doi: 10.1007/s12015-023-10653-8. Epub 2023 Nov 13.
PubMed 37955832
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Gastrocnemius Muscle Architecture and Functional Ability in Ambulatory Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT07437378
- Acronym / sponsor ID
- DU-PT-DMD-ARCH-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- 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.
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle degeneration, pseudohypertrophy, and declining functional mobility. This cross-sectional observational study investigates the relationship between gastrocnemius muscle architecture and functional ability in ambulatory children with DMD. Muscle thickness and fascicle length were assessed using ultrasonography and correlated with motor function and ankle plantarflexion during gait.
Detailed description
Duchenne Muscular Dystrophy (DMD) is a genetic neuromuscular disorder characterized by progressive muscle degeneration, fatty infiltration, fibrosis, and loss of functional capacity during childhood. Although pseudohypertrophy may cause apparent enlargement of calf muscles, structural changes do not necessarily reflect muscle quality or functional performance.
This cross-sectional observational study included 26 ambulatory male children aged 6 to 12 years diagnosed with DMD. Participants underwent a single comprehensive assessment session.
Muscle architecture of the medial gastrocnemius muscle was evaluated using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe) to measure muscle thickness and fascicle length.
Functional ability was assessed using:
- The Motor Function Measure (MFM-32)
- The Vignos Scale
- Timed 10-Meter Walk Test
Ankle plantarflexion range of motion during gait was measured using Kinovea motion analysis software with 2D digital video analysis.
Correlation analysis was performed to determine the relationship between muscle architectural parameters and functional ability measures.
No therapeutic intervention, randomization, or group allocation was performed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Children With Duchenne Muscular Dystrophy | – | –Male children aged 6 to 12 years diagnosed with Duchenne Muscular Dystrophy and able to ambulate. Participants underwent assessment of gastrocnemius muscle architecture using ultrasonography and evaluation of functional ability using standardized outcome measures during a single assessment session. No intervention was administered. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male children aged 6 to 12 years diagnosed with Duchenne Muscular Dystrophy who were ambulatory and recruited from outpatient pediatric physical therapy clinics. Participants met specific inclusion criteria including Vignos Scale grades 1 to 7 and presence of calf pseudohypertrophy. All participants underwent a single assessment session to evaluate gastrocnemius muscle architecture and functional ability. No therapeutic intervention was administered.
Key inclusion criteria (6 listed)
- Diagnosed with Duchenne Muscular Dystrophy
- Age 6-12 years
- Ambulatory
- Vignos Scale grades 1-7
- Presence of calf pseudohypertrophy
Key exclusion criteria (5 listed)
- Non-ambulatory
- Severe cognitive impairment
- History of lower limb trauma or fracture
- Inability to cooperate with assessment
- Lack of parental consent
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
Gastrocnemius Muscle Thickness and Fascicle Length
Time frame: Baseline
Measured using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe).
Functional Ability (Motor Function Measure-32)
Time frame: Baseline
Functional performance was assessed using the Motor Function Measure-32 scale.
Ankle Plantarflexion Range of Motion During Gait
Time frame: Baseline
Measured using Kinovea 2D motion analysis software.
Timed 10-Meter Walk Test
Time frame: Baseline
Time required to walk 10 meters is used to assess ambulatory performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 20599384Gaudreault N, Gravel D, Nadeau S, Houde S, Gagnon D. Gait patterns comparison of children with Duchenne muscular dystrophy to those of control subjects considering the effect of gait velocity. Gait Posture. 2010 Jul;32(3):342-7. doi: 10.1016/j.gaitpost.2010.06.003.
- Background: PubMed 23602884de Lattre C, Payan C, Vuillerot C, Rippert P, de Castro D, Berard C, Poirot I; MFM-20 Study Group. Motor function measure: validation of a short form for young children with neuromuscular diseases. Arch Phys Med Rehabil. 2013 Nov;94(11):2218-26. doi: 10.1016/j.apmr.2013.04.001. Epub 2013 Apr 18.
- BackgroundDarras, B. T., et al. (2014). Neuromuscular disorders of infancy, childhood, and adolescence: a clinician's approach, Elsevier.
- Background: PubMed 35195227Bulut N, Karaduman A, Alemdaroglu-Gurbuz I, Yilmaz O, Topaloglu H, Ozcakar L. Ultrasonographic assessment of lower limb muscle architecture in children with early-stage Duchenne muscular dystrophy. Arq Neuropsiquiatr. 2022 May;80(5):475-481. doi: 10.1590/0004-282X-ANP-2021-0038.
- Background: PubMed 16106528Berard C, Payan C, Hodgkinson I, Fermanian J; MFM Collaborative Study Group. A motor function measure for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005 Jul;15(7):463-70. doi: 10.1016/j.nmd.2005.03.004.
- Background: PubMed 37955832Akat A, Karaoz E. Cell Therapy Strategies on Duchenne Muscular Dystrophy: A Systematic Review of Clinical Applications. Stem Cell Rev Rep. 2024 Jan;20(1):138-158. doi: 10.1007/s12015-023-10653-8. Epub 2023 Nov 13.
- 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. This study is not recruiting at the moment.
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 Neuromuscular Disorders, run by Deraya University at 1 site in Egypt.
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 6 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 28 Aug 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 Egypt. 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?
Gastrocnemius Muscle Thickness and Fascicle Length (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT07437378, which also lists 6 linked publications.
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 28 Aug 2026.