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Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy

S

Shriners Hospitals for Children

Status

Completed

Conditions

Duchenne Muscular Dystrophy

Study type

Observational

Funder types

Other

Identifiers

NCT00312247
SHC-79115 (Other Grant/Funding Number)
SHC-DMD-79115

Details and patient eligibility

About

The purpose of this research study is to understand the walking patterns, strength and function changes of boys with Duchenne muscular dystrophy on/off corticosteroids to determine the best timing and treatment options to maintain walking for as long as possible.

Full description

Duchenne muscular dystrophy (DMD) is an X-linked recessive disease of muscle characterized by a progressive loss of functional muscle mass, which is replaced with fibrofatty tissue. Historically, boys with DMD lose the ability to walk between the ages of 8-12 years, due to progressive weakness of the quadriceps coupled with the development of contractures at the hip, knee and ankle. This progressive loss in function necessitates individuals with DMD to spend less time walking and more time in wheelchairs, leading to the development of spinal deformities. Recently, corticosteroids have been shown to reduce the expected loss of muscle strength, extend the time that ambulation and standing are maintained, and minimize or eliminate spinal deformity in individuals with DMD; yet, the side effects of such treatment preclude use in some patients. To date, differences in gait patterns and other markers of disease progression between boys on corticosteroids and those not utilizing such treatment have not been objectively quantified. This lack of knowledge is a major obstacle to determining the most effective treatment for subsets of boys with DMD.

Enrollment

85 patients

Sex

Male

Ages

4 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of DMD
  • Male.
  • Four years of age or older.
  • Ability to walk independently for five minutes to 10 minutes at self-selected speed.
  • Ability to cognitively understand directions for testing procedures.

Exclusion criteria

  • Female
  • Nonambulatory

Trial design

85 participants in 2 patient groups

Boys taking steroids
Description:
Boys who are taking prednisone or deflazacort
Boys who are steroid naive
Description:
Boys who are not taking steroids for a variety of reasons

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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