Study Purpose:
A 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. The investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Peggy Allred, PT DPT, Cedars-Sinai Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Cedars-Sinai Medical Center
Ashley Fetterman / email hidden; JavaScript is required / 310-423-8497
Los Angles, California, 90048 United States
Full Study Summary:
Cedars-Sinai Medical Center will enroll and collect data on 100 subjects. Subjects will ideally be tested every 1 to 4 months according to each patient's site visit schedule. Subjects will be tested at each visit using ATLIS, the ALSFRS-R questionnaire and EIM.
Study Sponsor:
Cedars-Sinai Medical Center
Participant Duration:
Subjects will be tested every 1 to 6 months for up to two years and no more than 6 times per year. Subjects will be tested at each visit using ATLIS and the ALSFRS-R questionnaire.
Estimated Enrollment:
100
Estimated Study Start Date:
03 / 01 / 2015
Estimated Study Completion Date:
02 / 01 / 2020
Posting Last Modified Date:
04 / 03 / 2018
Date Study Added to neals.org:
03 / 02 / 2015
Minimum Age:
18 Years
Maximum Age:
N/A
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).
- Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.
Cedars-Sinai Medical Center | Recruiting
Ashley Fetterman / 310-423-8497 / email hidden; JavaScript is required
Los Angeles, California
90048
United States