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

NCT07437378 | Completed

• 1 other identifier: DU-PT-DMD-ARCH-001
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 ambulatory children with DMD. Muscle thickness and fascicle length were assessed using ultrasonography and correlated with motor function and ankle plantarflexion during gait.

Conditions

Duchenne Muscular Dystrophy (DMD); Neuromuscular Disorders; Muscle Architecture

Outcome Measures

Primary Outcomes (4)

• Gastrocnemius Muscle Thickness and Fascicle Length

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

  Single Assessment Session

• Functional Ability (Motor Function Measure-32)

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

  Single Assessment Session

• Ankle Plantarflexion Range of Motion During Gait

  Measured using Kinovea 2D motion analysis software.

  Single Assessment Session

• Timed 10-Meter Walk Test

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

  Single Assessment Session

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Gender Eligibility Details: This study includes male participants only because Duchenne Muscular Dystrophy is an X-linked recessive genetic disorder that primarily affects males. Female carriers are typically asymptomatic or present with milder manifestations and were not included in this study population.
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Non-ambulatory
• Severe cognitive impairment
• History of lower limb trauma or fracture
• Inability to cooperate with assessment
• Lack of parental consent

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Deraya university, faculty of physical therapy

Minya, Menia Governorate, Egypt

Location

Related Publications (6)

• Gaudreault, N., et al. (2010). "Gait patterns comparison of children with Duchenne muscular dystrophy to those of control subjects considering the effect of gait velocity." Gait & Posture 32(3): 342-347.

  BACKGROUND

• De Lattre, C., et al. (2013). "Motor function measure: validation of a short form for young children with neuromuscular diseases." Archives of physical medicine and rehabilitation 94(11): 2218-2226.

  BACKGROUND

• Darras, B. T., et al. (2014). Neuromuscular disorders of infancy, childhood, and adolescence: a clinician's approach, Elsevier.

  BACKGROUND

• Bulut, N., et al. (2022). "Ultrasonographic assessment of lower limb muscle architecture in children with early-stage Duchenne muscular dystrophy." Arquivos de neuro-psiquiatria 80(05): 475-481.

  BACKGROUND

• Bérard, C., et al. (2005). "A motor function measure scale for neuromuscular diseases. Construction and validation study." Neuromuscular disorders 15(7): 463-470.

  BACKGROUND

• Akat, A. and E. Karaöz (2024). "Cell therapy strategies on Duchenne muscular dystrophy: A systematic review of clinical applications." Stem Cell Reviews and Reports 20(1): 138-158.

  BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: September 10, 2024
• Primary Completion: October 31, 2025
• Study Completion: November 10, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)