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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00606918

First Posted: February 5, 2008

Last Update Posted: May 12, 2011

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.

Information provided by:

Massachusetts General Hospital

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:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Neuromuscular Disorders

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

isometric strength measures [ Time Frame: cross sectional ]


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

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.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

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


Responsible Party:	Patricia L. Andres, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00606918 History of Changes
Other Study ID Numbers:	MDA-4343
First Submitted:	January 22, 2008
First Posted:	February 5, 2008
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:


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

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