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Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials

 
Study Focus:
The purpose of the study is to compare the relative sensitivity of 3 outcomes measures in measuring disease progression in patients with ALS over time.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Device
Study Status:
Active, no longer recruiting
Phase:
Not Applicable
Type:
Observational Study
Funding Source:
The ALS Association
Study Chair(s)/Principal Investigator(s):
Patricia L. Andres, DPT, MS (Massachusetts General Hospital)
NEALS Affiliated?
Yes
Study Summary:
A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. We will compare ATLIS data with data from two commonly used ALS outcomes measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years. Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital capacity testing.
Participant Duration:
Total time enrolled in study is up to 2 years. Subjects will spend about 45 minutes at each visit to the clinic (every 1 to 4 months) to complete study procedures.
# of Subjects:
100
Enrollment Start Date:
07/01/2013
Enrollment End Date:
12/01/2014
Posting Last Modified Date:
10/01/2013
Date Study Added to alsconsortium.org:
07/03/2013
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Coordinating Center
Contact Information
Patricia Andres
pandres1@partners.org
(617) 724-8995
Massachusetts General Hospital
1256 Bigelow NCRI 55 Fruit Street
Boston, Massachusetts 02114
UNITED STATES
Other Eligibility Criteria:
Inclusion criteria:
• Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
• Capable of providing informed consent and complying with trial procedures.
• Active movement of at least two limbs at the time of study entry
• Intend to routinely attend clinic for neurological care at the clinical site

Exclusion criteria:
• Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).

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