CompletedNCT00606918ATLISUpdated May 12, 2011

Validation of a New Device to Measure Neuromuscular Disease Progression

An observational study in Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-12.

Sponsored by Massachusetts General Hospital · Observational

Study type: Observational
Model: Case-control
Time perspective: Cross-sectional
Enrollment: 120
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

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Keywords

Strength testing
Disease progression
ALS
Healthy Adults

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 120 is above the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Individuals with ALS

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

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 design

Observational model: Case-control
Time perspective: Cross-sectional
Enrollment: 120 participants (estimated)

Groups and cohorts

1
Individuals with ALS
2
Healthy Adults

What researchers measure

Primary outcomes

isometric strength measures
Time frame: cross sectional

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00606918
Lead sponsor: Massachusetts General Hospital
First posted: Feb 5, 2008
Start date: Jan 2008
Primary completion: Sep 2010
Completion: Sep 2010
Last update: May 12, 2011

Study contacts

Patricia L. Andres, MS, DPT

principal investigator · Mass. General Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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