Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy
1 other identifier
observational
N/A
1 country
1
Brief Summary
Nearly all patients with Duchenne's Muscular Dystrophy (DMD) have scoliosis. Posterior instrumented spinal fusion, which is a surgery to correct scoliosis, has been shown to improve quality of life and satisfaction of both parents and families. The progressive muscular weakness leads to the development of scoliosis soon after the child has become unable to walk. The muscular weakness and scoliosis also affect the pulmonary function of these children. Pulmonary Function Tests (PFT) have been used to determine "pulmonary fitness" prior to surgery as a way to determine how well or if the child will tolerate surgery. Children with poor results on the PFT are determined to be too fragile to tolerate such a large operation. The physicians conducting this study feel that the PFT may be inaccurate and that this may not be the best single test to determine "pulmonary fitness". The physicians conducting the study think things like the time of day the study is done, how tired you are when you complete the test, and how well you understand the test may affect the results of the test.
Trial Health
Trial Health Score
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Started Mar 2004
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedFebruary 4, 2015
February 1, 2015
1.4 years
September 13, 2005
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFT training
2 weeks
Study Arms (1)
With and Without PFTs
Eligibility Criteria
You may qualify if:
- Male
- Duchenne's Muscular Dystrophy with diagnosed confirmed by a neurologist
- No longer able to ambulate for any meaningful amount of time
- No previous spinal operation
You may not qualify if:
- Any other type of muscular dystrophy or spinal muscular atrophy
- Tracheotomy
- Contractures of the upper extremities that would preclude using arm span as an estimation for height
- Previous spinal surgery
- Asthma, recurrent pneumonia, or other chronic lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Healthcare of Atlanta @ Scottish Rite
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Schrader, MD
Children's Orthopaedics of Atlanta
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
March 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
February 4, 2015
Record last verified: 2015-02