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OpenTrials
Completed

NCT Number: NCT07437378

Relation Between Muscle Architecture and Functional Ability in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gastrocnemius Muscle Thickness and Fascicle Length

    Time frame: Single Assessment Session

    Measured using 2-dimensional ultrasonography (Mindray DP-10, 7.5 MHz probe).

  2. Functional Ability (Motor Function Measure-32)

    Time frame: Single Assessment Session

    Functional performance was assessed using the Motor Function Measure-32 scale.

  3. Ankle Plantarflexion Range of Motion During Gait

    Time frame: Single Assessment Session

    Measured using Kinovea 2D motion analysis software.

  4. Timed 10-Meter Walk Test

    Time frame: Single Assessment Session

    Time required to walk 10 meters is used to assess ambulatory performance.

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

Relation Between Gastrocnemius Muscle Architecture and Functional Ability in Ambulatory Children With Duchenne Muscular Dystrophy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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