Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy
2 other identifiers
observational
85
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2006
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 5, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 19, 2015
May 1, 2015
8.7 years
April 5, 2006
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait pattern
computerized assessment of walking
every six months (2x/year)
Secondary Outcomes (4)
muscle strength
every six months (2x/year)
energy cost of walking
every six months (2x/year)
gross motor functional skills
every six months (2x/year)
Step activity Monitor-participation
one week every six months
Study Arms (2)
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
Eligibility Criteria
Boys with DMD who are ambulatory starting at the age of 4 until ambulation ceases
You may qualify if:
- 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.
You may not qualify if:
- Female
- Nonambulatory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UCLA Department of Orthopaedic Surgery
Los Angeles, California, 90095, United States
Shriners Hospitals for Children
Sacramento, California, 95817, United States
Shriners Hospitals for Children
Portland, Oregon, 97239, United States
Related Publications (2)
Sienko Thomas S, Buckon CE, Nicorici A, Bagley A, McDonald CM, Sussman MD. Classification of the gait patterns of boys with Duchenne muscular dystrophy and their relationship to function. J Child Neurol. 2010 Sep;25(9):1103-9. doi: 10.1177/0883073810371002. Epub 2010 Jun 29.
PMID: 20587736RESULTMcDonald CM, McDonald DA, Bagley A, Sienko Thomas S, Buckon CE, Henricson E, Nicorici A, Sussman MD. Relationship between clinical outcome measures and parent proxy reports of health-related quality of life in ambulatory children with Duchenne muscular dystrophy. J Child Neurol. 2010 Sep;25(9):1130-44. doi: 10.1177/0883073810371509. Epub 2010 Jun 17.
PMID: 20558672RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Sussman, MD
Shriners Hospitals for Children
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2006
First Posted
April 7, 2006
Study Start
April 1, 2006
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
May 19, 2015
Record last verified: 2015-05