Relation Between Muscle Architecture and Functional Ability in Children With Duchenne Muscular Dystrophy
August 26, 2026 updated by: Deraya University
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Menia Governorate
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Minya, Menia Governorate, Egypt
- Deraya university, faculty of physical therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-ambulatory
- Severe cognitive impairment
- History of lower limb trauma or fracture
- Inability to cooperate with assessment
- Lack of parental consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrocnemius Muscle Thickness and Fascicle Length
Time Frame: Baseline
|
Measured using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe).
|
Baseline
|
|
Functional Ability (Motor Function Measure-32)
Time Frame: Baseline
|
Functional performance was assessed using the Motor Function Measure-32 scale.
|
Baseline
|
|
Ankle Plantarflexion Range of Motion During Gait
Time Frame: Baseline
|
Measured using Kinovea 2D motion analysis software.
|
Baseline
|
|
Timed 10-Meter Walk Test
Time Frame: Baseline
|
Time required to walk 10 meters is used to assess ambulatory performance.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Berard 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.
- de 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.
- Darras, B. T., et al. (2014). Neuromuscular disorders of infancy, childhood, and adolescence: a clinician's approach, Elsevier.
- 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.
- 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.
- Akat 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2024
Primary Completion (Actual)
October 31, 2025
Study Completion (Actual)
November 10, 2025
Study Registration Dates
First Submitted
February 22, 2026
First Submitted That Met QC Criteria
February 22, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU-PT-DMD-ARCH-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.