Accurate Test of Limb Isometric Strength (ATLIS) in ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02374606|
Recruitment Status : Unknown
Verified March 2018 by Peggy Allred, PT DPT, Cedars-Sinai Medical Center.
Recruitment status was: Recruiting
First Posted : March 2, 2015
Last Update Posted : April 3, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Amyotrophic Lateral Sclerosis|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Accurate Test of Limb Isometric Strength (ATLIS) in ALS|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]ATLIS measures isometric strength in 12 muscle groups in the arms and legs. The subject is tested seated in a specially designed chairs with adjustable uprights. The subject's limb is placed in a standard position and maximal force is exerted on the wireless load cell fixed to the upright. Strength data is digitally captured and expressed as a percentage of expected normal.
- Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.
- Exploratory measure: Electrical impedance myography (EIM) data will be compared to ATLIS data. [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]EIM evaluates how electrical current flows through muscle which assists in determining muscle health by measuring electrical current in muscle. 14 muscle groups in the arms and legs will be tested in this study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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).
- Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374606
|Contact: Ashley Fettermanemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Ashley Fetterman 310-423-8497 katherine.fetterman@CSHS.org|
|Principal Investigator:||Peggy Allred, PT DPT||Cedars-Sinai Medical Center|
|Responsible Party:||Peggy Allred, PT DPT, Research Program Administrator/Neuromuscle Program Manager, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
|First Posted:||March 2, 2015 Key Record Dates|
|Last Update Posted:||April 3, 2018|
|Last Verified:||March 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases