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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
  Purpose

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
Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Validation of a New Device to Measure Neuromuscular Disease Progression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • isometric strength measures [ Time Frame: cross sectional ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Individuals with ALS
2
Healthy Adults

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606918

Locations
United States, Massachusetts
Massachusetts General Hospital - East
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Patricia L. Andres, MS, DPT Mass. General Hospital
  More Information

No publications provided

Responsible Party: Patricia L. Andres, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00606918     History of Changes
Other Study ID Numbers: MDA-4343
Study First Received: January 22, 2008
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Strength testing
Disease progression
ALS
Healthy Adults

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Sclerosis
Motor Neuron Disease
Disease Progression
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on April 14, 2014