Longitudinal Study of Outcomes Measures in ALS Trials

Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials

A new 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 investigators will compare ATLIS data with data from two commonly used ALS outcomes measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis

Detailed Description

Four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years. Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital capacity testing.

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.

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).

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with ALS

Description

Inclusion Criteria:

• 18 years or older
• clinically possible, laboartory supported probable, probable or clinically definite ALS according to El Escorial Criteria
• capable of providing informed consent

Exclusion Criteria:

• persons with medical conditions that would limit their ability to safely exert maximal force using muscles in their arms and legs (e.g. unstable cardiac, musculoskeletal, or other medical conditions)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 for up to two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 for up to 2 years
Change in Slow Vital Capacity (SVC) between each visit	SVC measures the amount of air you can exhale following a deep breath. For this test, we will ask you to hold a mouthpiece in your mouth, breathe in deeply, and breathe out as much air as you can, up to 5 times.	Every 1 to 4 months for up to two years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: ALS Association
• Investigators: Principal Investigator: Patricia L. Andres, DPT, MS, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (ESTIMATE): July 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: disease progression; outcomes measures; strength measurement
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 2013P000702