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Clinical Trials/NCT00312247
NCT00312247
Completed
N/A

Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy

Shriners Hospitals for Children2 sites in 1 country85 target enrollmentApril 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
Shriners Hospitals for Children
Enrollment
85
Locations
2
Primary Endpoint
Gait pattern
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
March 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael D. Sussman, MD

Principal Investigator

Shriners Hospitals for Children

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of DMD
  • 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

  • Nonambulatory

Outcomes

Primary Outcomes

Gait pattern

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

computerized assessment of walking

Secondary Outcomes

  • muscle strength(every six months (2x/year))
  • gross motor functional skills(every six months (2x/year))
  • energy cost of walking(every six months (2x/year))
  • Step activity Monitor-participation(one week every six months)

Study Sites (2)

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