Accurate Test of Limb Isometric Strength (ATLIS) in ALS

• ClinicalTrials.gov Identifier: NCT02374606
• Recruitment Status: Unknown
• First Posted: March 2, 2015
• Last Update Posted: April 3, 2018
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Peggy Allred, PT DPT, Cedars-Sinai Medical Center

Tracking Information

• First Submitted Date: February 24, 2015
• First Posted Date: March 2, 2015
• Last Update Posted Date: April 3, 2018
• Study Start Date: March 2015
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2016)

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.

Original Primary Outcome Measures (submitted: February 24, 2015)

Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 6 months for up to two years ]

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.

Current Secondary Outcome Measures (submitted: February 1, 2016)

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.

Original Secondary Outcome Measures (submitted: February 24, 2015)

Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit [ Time Frame: every 1 to 6 months for up to two years ]

This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.

Current Other Pre-specified Outcome Measures (submitted: February 1, 2016)

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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Accurate Test of Limb Isometric Strength (ATLIS) in ALS
• Official Title: Accurate Test of Limb Isometric Strength (ATLIS) in ALS
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Adults with ALS
• Condition: Amyotrophic Lateral Sclerosis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 24, 2015): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2020
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

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).
• Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02374606
• Other Study ID Numbers: Pro00038868
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Peggy Allred, PT DPT, Cedars-Sinai Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Cedars-Sinai Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peggy Allred, PT DPT; Cedars-Sinai Medical Center

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: March 2018