Clinical trial NCT01911130: Longitudinal Study of Outcomes Measures in ALS Trials
Official title: Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: outcomes measures
strength measurement
disease progression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2013-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with ALS

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit
timeFrame: 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
timeFrame: every 1 to 4 months for up to 2 years
measure: Change in Slow Vital Capacity (SVC) between each visit
timeFrame: Every 1 to 4 months for up to two years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Patricia L. Andres, DPT, MS
role: PRINCIPAL_INVESTIGATOR
References: