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Validation of a New Device to Measure Neuromuscular Disease Progression

Validation of a New Device to Measure Neuromuscular Disease Progression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00606918
Acronym
ATLIS
Enrollment
120
Registered
2008-02-05
Start date
2008-01-31
Completion date
2010-09-30
Last updated
2011-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Keywords

Strength testing, Disease progression, ALS, Healthy Adults

Brief summary

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
isometric strength measurescross sectional

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026