We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Validation of a New Device to Measure Neuromuscular Disease Progression (ATLIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00606918
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : May 12, 2011
Information provided by:
Massachusetts General Hospital

Brief 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.

Condition or disease
Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validation of a New Device to Measure Neuromuscular Disease Progression
Study Start Date : January 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Individuals with ALS
Healthy Adults

Primary Outcome Measures :
  1. isometric strength measures [ Time Frame: cross sectional ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with ALS

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606918

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital - East
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Layout table for investigator information
Principal Investigator: Patricia L. Andres, MS, DPT Mass. General Hospital
Layout table for additonal information
Responsible Party: Patricia L. Andres, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00606918    
Other Study ID Numbers: MDA-4343
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011
Keywords provided by Massachusetts General Hospital:
Strength testing
Disease progression
Healthy Adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Disease Progression
Pathologic Processes
Disease Attributes
Neurodegenerative Diseases
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases