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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00606918
First received: January 22, 2008
Last updated: May 11, 2011
Last verified: May 2011

January 22, 2008
May 11, 2011
January 2008
September 2010   (final data collection date for primary outcome measure)
isometric strength measures [ Time Frame: cross sectional ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606918 on ClinicalTrials.gov Archive Site
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Validation of a New Device to Measure Neuromuscular Disease Progression
Validation of a New Device to Measure Neuromuscular Disease Progression

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Individuals with ALS

Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders
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  • 1
    Individuals with ALS
  • 2
    Healthy Adults
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606918
MDA-4343
No
Patricia L. Andres, Massachusetts General Hospital
Massachusetts General Hospital
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Principal Investigator: Patricia L. Andres, MS, DPT Mass. General Hospital
Massachusetts General Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP