Validation of a New Device to Measure Neuromuscular Disease Progression (ATLIS)
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00606918
First received: January 22, 2008
Last updated: May 11, 2011
Last verified: May 2011
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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
U.S. FDA Resources
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606918
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 Disease Progression Neuromuscular Diseases Central Nervous System Diseases Disease Attributes Metabolic Diseases Motor Neuron Disease |
Nervous System Diseases Neurodegenerative Diseases Pathologic Processes Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies |
ClinicalTrials.gov processed this record on February 27, 2015