Accurate Test of Limb Isometric Strength (ATLIS) in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Accurate Test of Limb Isometric Strength (ATLIS) in ALS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02374606
• Other study ID #: Pro00038868
• Status: Recruiting
• First received: February 24, 2015
• Last updated: March 31, 2018
• Start date: March 2015
• Est. completion date: February 2020

Study information

• Verified date: March 2018
• Source: Cedars-Sinai Medical Center
• Contact: Ashley Fetterman
• Phone: 310-423-8497
• Email: katherine.fetterman[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory measure: Electrical impedance myography (EIM) data will be compared to ATLIS data.	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.	every 1 to 4 months according to each patient's site visit schedule
Primary	Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit	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.	every 1 to 4 months according to each patient's site visit schedule
Secondary	Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit	This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.	every 1 to 4 months according to each patient's site visit schedule