Longitudinal Study of Outcomes Measures in ALS Trials

NCT01911130 | Completed

• 1 other identifier: 2013P000702
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

outcomes measures; strength measurement; disease progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit

  every 1 to 4 months for up to 2 years

• Change in Slow Vital Capacity (SVC) between each visit

  Every 1 to 4 months for up to two years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with ALS

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ALS Association: collaborator

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia L. Andres, DPT, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 23, 2017

Record last verified: 2015-09

Locations

US (5)