Validation of a New Device to Measure Neuromuscular Disease Progression

Study Purpose:

This study will enable us to test the reliability and validity of Accurate Test of Limb Isometric Strength (ATLIS)

Disease:

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

Study Type:

Observational Study

Study Category:

Exercise

Study Status:

Not enrolling

Phase:

Not Applicable

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

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

Clinicaltrials.gov ID (11 digit #):

NCT00606918

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital - East
.(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) Charlestown, Massachusetts 02129 United States

Full Study Summary:

There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human 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. This study will enable us to test the reliability and validity of ATLIS.

Study Sponsor:

Massachusetts General Hospital

Participant Duration:

Estimated Enrollment:

120

Estimated Study Start Date:

11/02/2016

Estimated Study Completion Date:

11/02/2016

Posting Last Modified Date:

10/31/2011

Date Study Added to alsconsortium.org:

11/03/2011
  • Eligibility Criteria

    Gender:

    Neals Affiliated, Diseases, Study Type, Study Category, Study Status, Phase

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:

    •All subjects must be at least 18 years old and able to provide informed consent
    •All subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs.
    •Subjects with a diagnosis of laboratory supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial, as determined by their referring neurologist at MGH.
    •All subjects must be able to speak and understand English.
    Exclusion Criteria:

    •Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.

  • Site Contact Information

    Massachusetts General Hospital - East
    Charlestown, Massachusetts 02129
    United States

  • Study Results