Accurate Test of Limb Isometric Strength (ATLIS) in ALS

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT02374606
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-31
• Last Update Posted: 2018-04-03
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit	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.

Secondary Outcome Measures

Name	Time	Method
Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States