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

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ClinicalTrials.gov Identifier: NCT00606918
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Massachusetts General Hospital

Study Description
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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

Study Design
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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

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Groups and Cohorts
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Group/Cohort
1
Individuals with ALS
2
Healthy Adults


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

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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


Locations
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United States, Massachusetts
Massachusetts General Hospital - East
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Patricia L. Andres, MS, DPT Mass. General Hospital
More Information
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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
ALS
Healthy Adults
Additional relevant MeSH terms:
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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