ALS CLINICAL RESEARCH STUDY - Neuromuscular Disease
Validation of a New Device to Measure Neuromuscular Disease Progression Recruitment Status: Currently Recruiting Healthy Subjects Only Sponsor and Collaborators: MDA Purpose: The purposes of this study are to validate the ATLIS device and to develop a normal databank. The specific aims are to: 1) determine the reliability of the ATLIS device by testing each participate two separate times.; 2) determine the validity of the device by comparing it to the Tufts Quantitative Neuromuscular Exam (TQNE); and 3) develop a normal databank containing tests from at least 500 adults, without physical disability, to be used to develop regression equations for converting data to a percentage of normal. This will allow fair comparisons between different muscle groups and among subjects whose normal strength is quite disparate. Detailed Description: There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in subjects more efficiently. If we could more precisely measure whether an experimental drug slows the progression of ALS or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. Eligibility: Healthy adults at least 18 years of age and have no conditions or injuries that may interfere with your ability to safely generate maximal resistance in the muscles in their arms and legs are eligible to participate. Persons with ALS: Adults with a possible, probable or definite diagnosis of ALS and have no conditions or injuries that may interfere with your ability to safely generate maximal resistance in the muscles in their arms and legs are eligible to participate. Sites and Contact Information: Volunteers: Please see BELOW for a complete list of participating sites. Volunteers may contact individual study coordinators at the participating sites directly. California Pacific Medical Center San Francisco, CA Michelle Mendoza, PT (415) 600-1431 MendozMC@cpmcri.org Massachusetts General Hospital Boston, MA Pat Andres, DPT, MS (617) 724-8995 Pandres1@partners.org University of Kentucky Lexington, KY Tony English, PT, PhD (859) 218-0834 tenglish@uky.edu University of Vermont Burlington, VT Sharon Hallman, PT (802) 847-1902 Sharon.Hallman@vtmednet.org Washington University St. Louis, MO Julaine Florence, DPT (314) 362-6983 florencej@neuro.wustl.edu Jeanine Schierbecker, PT schierbeckerj@neuro.wustl.edu Betsy Malkus, PT, MHS (314) 362-1624 malkusb@neuro.wustl.edu Catherine Siener, PT (314) 362-8651 sienerc@neuro.wustl.edu
Coordinating Center Contact Information: Patricia Andres, MS, DPT MGH East, 13th Street Bldg 149, Rm. 2274 Charlestown, MA 02129 617-724-8995 pandres1@partners.org |