Expired Study
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Charlestown, Massachusetts 02129


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.


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.


Study is Available At:


Original ID:

MDA-4343


NCT ID:

NCT00606918


Secondary ID:


Study Acronym:

ATLIS


Brief Title:

Validation of a New Device to Measure Neuromuscular Disease Progression


Official Title:

Validation of a New Device to Measure Neuromuscular Disease Progression


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Patricia L. Andres, MS, DPT
Principal Investigator
Mass. General Hospital

Study Dates

Start Date:January 2008
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 11, 2011
First Received Date:January 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:isometric strength measures
Time Frame:cross sectional
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Individuals with ALS
Study Arm Type:Other
Arm Name:2
Description:Healthy Adults

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital

Samples and Retentions

Study Population: Individuals with ALS
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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