Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials
Study Purpose:The purpose of the study is to compare the relative sensitivity of 3 outcomes measures in measuring disease progression in patients with ALS over time.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Observational Study
Study Chair(s)/Principal Investigator(s):Patricia L. Andres, DPT, MS (Massachusetts General Hospital)
Clinicaltrials.gov ID (11 digit #):
Coordinating Center Contact InformationMassachusetts General Hospital
Boston, Massachusetts 02114 United States
Full Study Summary:A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. We will compare ATLIS data with data from two commonly used ALS outcomes measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.
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.
Study Sponsor:The ALS Association
Participant Duration:Total time enrolled in study is up to 2 years. Subjects will spend about 45 minutes at each visit to the clinic (every 1 to 4 months) to complete study procedures.
Estimated Study Start Date:06/30/2013
Estimated Study Completion Date:11/30/2014
Posting Last Modified Date:12/31/2015
Date Study Added to alsconsortium.org:07/02/2013
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?
• 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.
• Active movement of at least two limbs at the time of study entry
• Intend to routinely attend clinic for neurological care at the clinical site
• 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).
Site Contact Information
Cedars-Sinai Medical Center
127 S. San Vicente Blvd.
Los Angeles, California 90048
Washington University School of Medicine
660 S. Euclid
St. Louis, Missouri 63110
University of Kentucky
Department of Physical Therapy Room 204S Wethington Building
Lexington, Kentucky 40536
Hershey Medical Center
Department of Neurology, H037
Hershey, Pennsylvania 17033
Massachusetts General Hospital
1256 Bigelow NCRI 55 Fruit Street
Boston, Massachusetts 02114