Validation of a New Device to Measure Neuromuscular Disease Progression (ATLIS)
| Tracking Information | |||||
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| First Received Date ICMJE | January 22, 2008 | ||||
| Last Updated Date | May 11, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
isometric strength measures [ Time Frame: cross sectional ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00606918 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of a New Device to Measure Neuromuscular Disease Progression | ||||
| Official Title ICMJE | Validation of a New Device to Measure Neuromuscular Disease Progression | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Individuals with ALS |
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| Condition ICMJE | Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00606918 | ||||
| Other Study ID Numbers ICMJE | MDA-4343 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Patricia L. Andres, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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