Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis
Sponsor Massachusetts General Hospital
Collaborator ALS Association
Start date July 2013
End date June 2015
Trial size 100 participants
Trial identifier NCT01911130, 2013P000702

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit
time frame: every 1 to 4 months for up to two years

Secondary Outcomes

Measure
Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit
time frame: every 1 to 4 months for up to 2 years
Change in Slow Vital Capacity (SVC) between each visit
time frame: Every 1 to 4 months for up to two years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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)

Additional Information

Official title Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials
Principal investigator Patricia L. Andres, DPT, MS
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.