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

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital - East

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with ALS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Individuals with ALS
2; Healthy Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
isometric strength measures	cross sectional

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Patricia L. Andres, MS, DPT, Mass. General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: January 22, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (ESTIMATE): February 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: ALS; Disease progression; Healthy Adults; Strength testing
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Disease Progression; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neuromuscular Diseases
• Other Study ID Numbers: MDA-4343