Accurate Test of Limb Isometric Strength (ATLIS) in ALS

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Device

Study Status:

Active, currently recruiting

Phase:

Not Applicable

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

Peggy Allred, PT DPT Cedars-Sinai Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT02374606

Neals Affiliated?

No

Coordinating Center Contact Information

Cedars-Sinai Medical Center
Ashley Fetterman / .(JavaScript must be enabled to view this email address) / 310-423-8497
.(JavaScript must be enabled to view this email address) Los Angles, California 90048 United States

Full Study Summary:

A 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. The investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Study Sponsor:

Cedars-Sinai Medical Center

Participant Duration:

Subjects will be tested every 1 to 6 months for up to two years and no more than 6 times per year. Subjects will be tested at each visit using ATLIS and the ALSFRS-R questionnaire.

Estimated Enrollment:

100

Estimated Study Start Date:

02/28/2015

Estimated Study Completion Date:

01/31/2018

Posting Last Modified Date:

11/02/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • 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).
    -Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.

  • Site Contact Information

    Cedars-Sinai Medical Center
    Ashley Fetterman / .(JavaScript must be enabled to view this email address) / 310-423-8497
    Los Angles, California 90048
    United States