Validation of a New Device to Measure Neuromuscular Disease Progression

NCT ID: NCT00606918

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Individuals with ALS

No interventions assigned to this group

2

Healthy Adults

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Patricia L. Andres, MS, DPT

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital - East

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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MDA-4343

Identifier Type: -

Identifier Source: org_study_id

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