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Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT00312247
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : May 19, 2015
Information provided by (Responsible Party):
Michael D. Sussman, MD, Shriners Hospitals for Children

Brief Summary:
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.

Condition or disease
Duchenne Muscular Dystrophy

Detailed 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.

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy
Study Start Date : April 2006
Primary Completion Date : December 2014
Study Completion Date : March 2015

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

Primary Outcome Measures :
  1. Gait pattern [ Time Frame: every six months (2x/year) ]
    computerized assessment of walking

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Boys with DMD who are ambulatory starting at the age of 4 until ambulation ceases

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312247

United States, California
UCLA Department of Orthopaedic Surgery
Los Angeles, California, United States, 90095
Shriners Hospitals for Children
Sacramento, California, United States, 95817
United States, Oregon
Shriners Hospitals for Children
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Shriners Hospitals for Children
Principal Investigator: Michael D Sussman, MD Shriners Hospitals for Children

Additional Information:
Responsible Party: Michael D. Sussman, MD, Principal Investigator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00312247     History of Changes
Other Study ID Numbers: SHC-DMD-79115
SHC-79115 ( Other Grant/Funding Number: Shriners Hospitals for Children )
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Michael D. Sussman, MD, Shriners Hospitals for Children:
Muscle Strength
Energy Cost
Quality of Life

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked