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 Category:

Device

Study Status:

Closed

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Patricia L. Andres, DPT, MS (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
Patricia Andres / .(JavaScript must be enabled to view this email address) / (617) 724-8995
.(JavaScript must be enabled to view this email address) 1256 Bigelow NCRI 55 Fruit Street
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 Enrollment:

100

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion criteria:
    • 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

    Exclusion criteria:
    • 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
    Peggy Allred, DPT / .(JavaScript must be enabled to view this email address) / (424) 315-2694
    127 S. San Vicente Blvd.
    Los Angeles, California 90048
    United States

    University of Kentucky
    Tony English, PT, PhD / .(JavaScript must be enabled to view this email address) / (859) 323-1100 x80834
    Department of Physical Therapy Room 204S Wethington Building
    Lexington, Kentucky 40536
    United States

    Massachusetts General Hospital
    Christina Dheel / .(JavaScript must be enabled to view this email address) / 617-643-6252
    1256 Bigelow NCRI 55 Fruit Street
    Boston, Massachusetts 02114
    United States

    Washington University School of Medicine
    Catherine Siener, PT, MHS / .(JavaScript must be enabled to view this email address) / 314-362-8651
    660 S. Euclid
    St. Louis, Missouri 63110
    United States

    Hershey Medical Center
    Beth Stephens / .(JavaScript must be enabled to view this email address) / (717) 531-0003 x 283395#
    Department of Neurology, H037
    Hershey, Pennsylvania 17033
    United States