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NCT Number: NCT00312247

Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy

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.

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Key information

Age range

4 year–21 year

Sex eligibility

Male

Study type

Observational

Primary location

UCLA Department of Orthopaedic Surgery, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Gait pattern

    Time frame: every six months (2x/year)

    computerized assessment of walking

Secondary outcomes

  1. muscle strength

    Time frame: every six months (2x/year)

    quantitative assessment of strength with a Biodex

  2. energy cost of walking

    Time frame: every six months (2x/year)

    assessment of how much energy it takes to walk, assessed with a Cosmed K4b2

  3. gross motor functional skills

    Time frame: every six months (2x/year)

    assessment of gross motor skills, ie getting up off the floor, ascending/descending stairs

  4. Step activity Monitor-participation

    Time frame: one week every six months

    measurement of the number of steps taken in the community/home environment during weekdays and weekends

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Important dates

Study start
2006
Primary completion
2014
Study completion
2015
First posted
Apr 7, 2006
Registry last updated
May 19, 2015

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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