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Sponsored by: |
Children's Healthcare of Atlanta |
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Information provided by: | Children's Healthcare of Atlanta |
ClinicalTrials.gov Identifier: | NCT00207857 |
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.
Condition |
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Duchenne's Muscular Dystrophy Scoliosis |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | Test-Retest Reliability of Pulmonary Function Tests in Patients With Duchenne's Muscular Dystrophy |
Estimated Enrollment: | 100 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | August 2005 |
All patients with DMD have routine PFT’s every six months as standard of care. You will be randomized in to one of two groups. The group assignment will be chosen by chance, similar to flipping a coin. If you are assigned to group one you will first have your regularly scheduled PFT in the morning. You will be asked to complete a second PFT that afternoon as least 4 hours after the first PFT. You will then be asked to come back to the clinic in two weeks and repeat these PFT’s, once in the morning and once in the afternoon at least 4 hours apart. Each PFT will take approximately 10 to 15 minutes. If you are assigned to group two, you will have your regularly scheduled PFT in the morning and then a second test in the afternoon at least four hours after the first test. After the second PFT you will receive training from a Respiratory Therapist. You will receive teaching handouts to take home and an incentive spirometer and peak flow meter to practice with. You will be asked to practice these tests 2 times a day and record your results. You will then be asked to come back to the clinic in two weeks to repeat 2 PFT’s, once in the morning and again at least 4 hours later. All participants will be asked how they feel at the time of testing.
Ages Eligible for Study: | 6 Years to 21 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elena Morales, BS | elena.morales@choa.org |
United States, Georgia | |
Children's Healthcare of Atlanta @ Scottish Rite | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Elena Morales, BS elena.morales@choa.org | |
Principal Investigator: Tim Schrader, MD |
Principal Investigator: | Tim Schrader, MD | Children's Orthopaedics of Atlanta |
Study ID Numbers: | Duchenne's Muscular Dystrophy |
Study First Received: | September 13, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00207857 |
Health Authority: | United States: Food and Drug Administration |
Duchenne's Muscular Dystrophy Scoliosis |
Spinal Diseases Scoliosis Muscular dystrophy, Duchenne and Becker type Bone Diseases Muscular Dystrophies Muscular Diseases Becker's muscular dystrophy Muscular Disorders, Atrophic |
Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Genetic Diseases, X-Linked Duchenne muscular dystrophy Atrophy Muscular dystrophy |
Spinal Curvatures Nervous System Diseases |