Longitudinal Study of Outcomes Measures in ALS Trials
Amyotrophic Lateral Sclerosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials|
- Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 4 months for up to two years ] [ Designated as safety issue: No ]ATLIS measures isometric strength in 12 muscle groups in the arms and legs. The subject is tested seated in a specially designed chairs with adjustable uprights. The subject's limb is placed in a standard position and maximal force is exerted on the wireless load cell fixed to the upright. Strength data is digitally captured and expressed as a percentage of expected normal.
- Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit [ Time Frame: every 1 to 4 months for up to 2 years ] [ Designated as safety issue: No ]This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.
- Change in Slow Vital Capacity (SVC) between each visit [ Time Frame: Every 1 to 4 months for up to two years ] [ Designated as safety issue: No ]SVC measures the amount of air you can exhale following a deep breath. For this test, we will ask you to hold a mouthpiece in your mouth, breathe in deeply, and breathe out as much air as you can, up to 5 times.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years. Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital capacity testing.
- Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
- Capable of providing informed consent and complying with trial procedures.
- Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911130
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Patricia L. Andres, DPT, MS||Massachusetts General Hospital|